One product, one panel, one record.
Align Extra Strength Probiotic Supplement — label audit
The label prints both numbers: "Contains 5 x 10⁹ (five billion) live bacteria/CFU when manufactured, and provides an effective level of bacteria (5 x 10⁷ CFU) until at least the 'best by' date." That is a hundredfold gap, and the same label carries the words "Guaranteed potency". What is guaranteed is one percent of the advertised number.
This page is an audit of a label. It records what this product’s panel discloses, what of that could be checked against a primary record, and what could not. The score below ranks this product on that disclosure and on nothing else.
The record this page rests on
- NIH label record
- Label read on
- The most recent dated artefact behind this page. Labels change; this is how old our reading of it is.
- Cohort
- Addendum — outside the founding denominators Torn down 2026-07-31, outside the frozen founding cohort of 27 and outside every D27 denominator.
- How deep this went
- Full forensic teardown Panel transcribed, every strain designator queried, every certification chased to its issuer’s own register, and the literature behind each marketing claim opened and read.
- What did not survive verification
- Part of this page was refuted or could not be reproduced Three things bound what this page may be quoted for. (1) No price exists for this product at any source this pass could reach — the brand's own page has no price, no currency and no cart, and four retailers failed — so no cost per day is published or estimated, and the aggregator figure of $35.23 for a different pack count is deliberately not recorded. (2) The doses used in the trials that built this strain's reputation were not fixed from full texts, so no specific studied-dose figure appears anywhere here. The dose finding as published rests only on the label's own guaranteed floor and on the fact that the floor is where the guarantee is expressed; a number for the trial dose must be verified against primary sources before it is quoted. (3) DSLD 278089 pairs the Extra Strength mass with the regular-strength CFU footnote, so a reader checking that record alone will see different figures than this page reports. The 5 billion / 50 million pair is used because DSLD 180448 and two independent retail listings agree on it. The hundredfold gap itself, which is what this page is about, is quoted verbatim from the label and stands.
The Label Verifiability Score for this product
100.0 out of 100
Rank 1 of the 154 products in this audit the rubric can score. This rank is shared with 18 other products — 19 products sit on 100.0 and are tied. They hold the position jointly; no tiebreaker is applied, because every tiebreaker available here would be a number the rubric deliberately refused to weigh, smuggled back in to make a list look tidier.
The score measures one thing: how much of what you are buying this company tells you, and how much of that survives being checked against a source that is not the company. It does not measure whether the product works — this site holds no efficacy data of its own, and 0 of 294 organism slots in the founding cohort carry a strain with a human randomised trial for any male-specific outcome, so nobody in this category has evidence that would support a ranking by effect.
Computed over 86% of the rubric by weight — the share of the five questions below this record could answer. The remaining question is unanswered, and unanswered is not nought: it leaves the divisor rather than dragging the score down. That share travels with the number and is never dropped — this score over 86% of the weight and the same score over all of it are different claims.
| Component | Weight | What was counted, and where | Fraction | Weight × fraction |
|---|---|---|---|---|
| Strain identity printed on the panel | 0.24 | 1 of 1 organism slot carries a printed strain designator. | 1 / 1 = 1.0000 | 0.2400 |
| Per-organism amount printed | 0.20 | 1 of 1 organism slot has an amount of its own; the rest are inside a blend total. | 1 / 1 = 1.0000 | 0.2000 |
| What the CFU count is measured against | 0.22 | Potency basis "both-endpoints": CFU figure printed yes, single basis stated yes, basis reaches expiry yes — 3 of 3. | 3 / 3 = 1.0000 | 0.2200 |
| Printed designators that lead to a human trial | 0.20 | 1 of 1 checked organism slot resolves to at least one human randomised trial under the designator exactly as printed. This counts whether the identity leads to a trial, never what the trial found. | 1 / 1 = 1.0000 | 0.2000 |
| Certification confirmed at the issuer’s own register | 0.14 | Every certification on this record is brand-asserted with the register unreachable, or not yet queried. An unreachable register is a fact about the verification infrastructure, not about this brand, so it may not move its position. | Not answered | — excluded from the divisor, not counted as nought |
0.8600 — the last column added up — divided by 0.86, the weight this record could answer, is 1.0000. Multiplied by 100 and rounded to one decimal, that is the 100.0 above.
See this product’s row in the full ranking, alongside the other 153 scored products, or read what each of the five components asks and how to check it .
What this label discloses
Everything in this table is what the product itself states — on the printed panel, on the brand’s own page, or in the label record the manufacturer filed. Nothing in it is checked yet; checking is the next section.
| Disclosure | As recorded |
|---|---|
| CFU as printed | 5 x 10⁹ (five billion) live bacteria/CFU when manufactured; an effective level of bacteria (5 x 10⁷ CFU) until at least the "best by" date |
| What that count is measured against | Both endpoints printed |
| Strain designators | All organisms coded |
| Organism slots transcribed here | 1 — the full panel |
| Marketed as | Unisex |
"Contains 5 x 10⁹ (five billion) live bacteria/CFU when manufactured, and provides an effective level of bacteria (5 x 10⁷ CFU) until at least the 'best by' date." Retail copy makes the sleight explicit: "5X Extra Strength^ comes in a once-a-day capsule and is guaranteed to deliver an effective level of probiotics through the best by date." "An effective level" is the term of art doing the work — the brand defines it, and it is one percent of the headline.
The panel’s own words on potency, verbatim.
The panel prints both a manufacture figure and an expiration figure, so the decline over shelf life is readable off the label itself.
Every organism on the panel carries a printed strain designator. Whether those designators lead anywhere is a separate question, answered below.
| Organism as printed | Designator as printed | Quantity as printed | What the designator resolves to | The query we ran |
|---|---|---|---|---|
| Bifidobacterium longum subsp. longum | 35624 | 17.5 mg | Human RCT | ("Bifidobacterium 35624"[tiab] OR "Bifidobacterium longum 35624"[tiab] OR "Bifidobacterium infantis 35624"[tiab] OR "UCC35624"[tiab] OR "NCIMB 41003"[tiab]) AND randomized controlled trial[pt] AND humans[mh] |
What of that is verifiable
A disclosure is verifiable when a reader can open a record that neither we nor the brand controls and see the same thing. Below is every dated artefact this page rests on. What is absent from this list is not verified, however reasonable it sounds.
- NIH Dietary Supplement Label Database record — DSLD 180448 (opens in a new tab) captured The 2018 Align Extra Strength record. Source of the 5 x 10⁹ / 5 x 10⁷ footnote quoted verbatim, confirmed independently on two retail listings (21-count and 42-count).
- NIH Dietary Supplement Label Database record — DSLD 278089 (opens in a new tab) captured The 2022 record, UPC 0 37000 50505 1, 17.5 mg. Its CFU footnote is the regular-strength one and contradicts 180448 and both retail listings — recorded here as a transcription carryover, and flagged rather than papered over.
- NIH Dietary Supplement Label Database record — DSLD 278084 (opens in a new tab) captured Regular-strength Align, 28 count, UPC 0 37000 14343 7 — 4 mg and the 1x10⁹ / 1x10⁷ footnote. The comparator for the "5X" claim. Record 278088 (14 ct, UPC 0 37000 93952 8) matches it.
- Dated capture of the brand’s own page — align-extra-strength-pdp-2026-07-31https://www.alignprobiotics.com/en-us/products/probiotics-digestive-support/extra-strength-probiotic-supplement — Address given, not linked: this site does not link out to the products it audits. captured Fetched HTTP 200. Its Next.js payload was parsed in full — no price, no cart, no absolute CFU, and a Supplement Facts panel that exists only as an image.
How many of its strains have a human trial for what it is sold for
Across the frozen founding cohort, 0 of 294 organism slots (0.0%) carry an organism with a human randomised controlled trial for any male-specific outcome. Not for this product — for all 27 of the founding teardowns, taken together. That is the number to hold against any men’s probiotic, including this one.
Two further founding-cohort figures for context: only 43 of 294 organism slots carry a strain with any human RCT at all under the exact code printed on the label, and only 2 of 27 products have a published human trial of the finished formula — the thing actually in the bottle. All three figures divide by the frozen cohort of 27 teardowns and 294 organism slots, never by every teardown on this site.
For this product specifically, 1 organism slot carries a strain with a human RCT under the exact designator printed on the label.
A word on what a designator has to clear before it counts here. The organism must be named with the exact strain code that appears in the trial, the trial must be in humans, and the code must return that trial when a reader searches it. A species name does not qualify: the trials in this field are of strains, and a species contains thousands of them.
What it costs per day
What certification it holds, checked at the issuer’s own register
A badge on a bottle is a claim like any other. Every row below was checked — or not checked — at the certifier’s own public register, never at the badge. Across the frozen founding cohort, 2 of 27 products hold a certification we could confirm at the issuer — a founding-cohort figure, not a count over every teardown on this site.
| Programme | Status at the issuer | Checked |
|---|---|---|
| Any third-party certification | Not checked | 31 July 2026 |
| "Each lot is DNA tested" | Not checked | not checked |
Any third-party certification
We have not queried this register for this product. It does not mean the product holds nothing.
None is claimed, so there is no issuer register to check. A word-boundary scan of the brand page for NSF, USP Verified, Informed-Choice, Non-GMO Project, ConsumerLab, cGMP, third-party tested and certified by returned zero hits on every term. What is claimed is gluten free, soy free, vegetarian, "No refrigeration required", "Guaranteed potency", and "Each lot is DNA tested to ensure it contains our unique strain".
"Each lot is DNA tested"
We have not queried this register for this product. It does not mean the product holds nothing.
In-house testing, brand-asserted, with no issuer, no standard named and no certificate published. It is identity testing — whether the right organism is present — and says nothing about viable count, potency at expiry or contaminants. It must not be allowed to read as third-party certification.
How it differs from the same brand’s women’s version
Across the fourteen same-brand men’s-versus-women’s label diffs run inside the frozen founding cohort, zero men’s or default formulas contain a probiotic strain, identified by designator, that was selected on male-specific evidence. In eight of the fourteen the sex-specific differentiator is a botanical or a mineral, and in five of the fourteen the women’s SKU is better-specified, cheaper, or both — “better-specified” meaning the panel that discloses more, never the panel with more in it. The rule behind each of those counts, and all fourteen pairs classified against it , are published in full. Diffs run on teardowns added since sit outside this fourteen, and outside the sentence above.
Every finding on this page, with the record behind it
Finding 1 hundredfold-gap-between-advertised-and-guaranteed-potency
5,000,000,000 CFU when manufactured against 50,000,000 CFU guaranteed until best-by. Ninety-nine percent of the advertised dose is not guaranteed for any of the product's shelf life. The single worst potency-disclosure structure found in this project — and, in fairness, the label does print both numbers, which most of this category does not.
The record: DSLD 180448, footnote verbatim, confirmed independently on two retail listings (21 ct and 42 ct) — open it (opens in a new tab)
Finding 2 guaranteed-potency-badge-over-a-one-percent-guarantee
The label carries the words "Guaranteed potency" while what is guaranteed is the 50 million, not the 5 billion. "An effective level" is brand-defined and appears as no number at all on the brand's own site.
The record: DSLD 180448 label copy against alignprobiotics.com product page, both 2026-07-31 — open it (opens in a new tab)
Finding 3 brand-page-states-no-absolute-cfu-at-all
The token "billion" appears zero times on the product page. The only potency statement is relative — "5x the active CFUs vs. Align capsules" — and the Supplement Facts exists only inside a product JPEG. A shopper on Align's own site cannot learn the dose in any unit.
The record: Full scan of the alignprobiotics.com Next.js payload and page text, 2026-07-31 — open ithttps://www.alignprobiotics.com/en-us/products/probiotics-digestive-support/extra-strength-probiotic-supplement — Address given, not linked: this site does not link out to the products it audits.
Finding 4 supplement-facts-is-machine-unreadable
Image-only on the brand site — the panel's alt text reads "Supplement Facts label for probiotic capsules containing Bifidobacterium longum, showing 21 servings per container with orange border." The mass and the CFU footnote had to be recovered from the government record and retail listings.
The record: alignprobiotics.com product page, image altText verbatim, 2026-07-31
Finding 5 five-x-claim-is-measured-at-manufacture
Regular-strength Align is 4 mg and "1x10⁹ (one billion) … when manufactured, and provides an effective level (1 x 10⁷ CFU) until at least 'best by' date". So "5X more good bacteria" is 17.5 mg against 4 mg — 4.4 times by mass, 5 times by at-manufacture CFU. The comparison is made at the point most favourable to the claim.
The record: DSLD 278084 and DSLD 278088 against DSLD 180448 — open it (opens in a new tab)
Finding 6 guaranteed-floor-sits-below-the-studied-dose
The "20+ years of research" behind this strain was done at doses the guarantee does not promise. Whether a buyer receives a studied dose depends entirely on how old the box is, and nothing on the label lets them find out.
The record: DSLD 180448 footnote against the strain's randomised literature (8 RCTs under the alias block)
Finding 7 dna-testing-presented-where-certification-would-go
"Each lot is DNA tested to ensure it contains our unique strain" is in-house identity testing with no issuer, no standard and no published certificate. It says nothing about viable count, potency at expiry or contaminants.
The record: alignprobiotics.com product page, read 2026-07-31
Finding 8 efficacy-substituted-by-authority
The persuasive load is carried by claims that are not efficacy claims. "#1 Doctor and #1 Gastroenterologist recommended probiotic brand‡" is footnoted to ProVoice 2008-2023 and ProVoice 2013-2023 surveys — a survey of what doctors recommend, not a trial of whether it works. "4 out of 5 people felt more confident with their digestive health after using Align Probiotic" is footnoted to "1,612 Align user reviews from alignprobiotics.com as of 3/31/2021" — self-reported confidence from the brand's own website reviews, five years stale, uncontrolled. Feeling more confident about digestive health is not having better digestive health.
The record: alignprobiotics.com product page claim footnotes, verbatim, 2026-07-31 — open ithttps://www.alignprobiotics.com/en-us/products/probiotics-digestive-support/extra-strength-probiotic-supplement — Address given, not linked: this site does not link out to the products it audits.
Finding 9 no-price-on-the-brands-own-site
No price field, no currency field, no cart and no buy button in the page payload. Align is retailer-only, and none of four retailers could be read this session either.
The record: Full parse of the alignprobiotics.com Next.js payload, 2026-07-31
Finding 10 government-record-carries-a-contradictory-cfu-footnote
DSLD 278089 pairs the Extra Strength mass of 17.5 mg with the regular-strength footnote of 1x10⁹ / 1x10⁷. DSLD 180448 and two independent retail listings all give 5x10⁹ / 5x10⁷. A citation trap for anyone checking one source.
The record: DSLD 278089 against DSLD 180448 and two retail listings — open it (opens in a new tab)
Finding 11 contains-milk-and-titanium-dioxide
Sodium caseinate and titanium dioxide (color) are both in the ingredient list, and neither is disclosed above the fold — worth reading beside a competitor on the same shelf that markets its carton as "100% titanium dioxide free".
The record: Brand-supplied ingredient statements on two retail listings, read 2026-07-31
What we could not verify
Every gap below is published rather than deleted. Most are derived automatically from the empty fields in this page’s own record, so a gap cannot be hidden by leaving a box blank.
- Any third-party certification status
- None is claimed, so there is no issuer register to check. A word-boundary scan of the brand page for NSF, USP Verified, Informed-Choice, Non-GMO Project, ConsumerLab, cGMP, third-party tested and certified by returned zero hits on every term. What is claimed is gluten free, soy free, vegetarian, "No refrigeration required", "Guaranteed potency", and "Each lot is DNA tested to ensure it contains our unique strain".
- "Each lot is DNA tested" status
- In-house testing, brand-asserted, with no issuer, no standard named and no certificate published. It is identity testing — whether the right organism is present — and says nothing about viable count, potency at expiry or contaminants. It must not be allowed to read as third-party certification.
- A US retail price, and therefore the cost per day
- Unverified at every source, and the brand publishes none. The Next.js payload behind Align's own product page was parsed in full: it contains no price field, no currency field, no cart and no buy button. Align is retailer-only and its own site is informational. Retailer fetches all failed — Amazon buybox geo-suppressed for the session, CVS 403, Walmart bot-blocked, Target 404. A SingleCare aggregator page surfaced in search asserting "$35.23 for 28 capsules"; that is a different count from a price aggregator, and it is not recorded as this product's price. Being unable to price a #1-doctor-recommended pharmacy product from the brand's own site is itself a finding about this category.
- A men’s-versus-women’s label diff
- The same brand’s women’s SKU has not been compared against this panel.
- The price, at any source
- Align's own product page carries no price, no currency field, no cart and no buy button; Amazon was geo-suppressed, CVS 403'd, Walmart bot-blocked and Target 404'd. No cost per day is computed or estimated here.
- The dose used in the trials that built this strain's reputation
- The classic IBS work is understood to have dosed on the order of 1 x 10⁸ CFU a day, against a guaranteed floor of 5 x 10⁷ at best-by. Full texts were not pulled in this pass to fix the exact trial doses, so that figure is directional only and is not published as a number anywhere on this page. The shape of the problem does not depend on it: whether a buyer receives a studied dose depends entirely on how old the box is, and the label gives no way to know, because the guarantee is expressed at the floor rather than at purchase.
- Which CFU footnote belongs to this SKU in DSLD 278089
- Record 278089 ("Align Probiotic Extra Strength", UPC 0 37000 50505 1) lists 17.5 mg — the Extra Strength mass — but attaches the footnote "1x10⁹ … 1 x 10⁷", which is the regular-strength footnote carried by records 278084 and 278088. Against it, DSLD 180448 (also Extra Strength, also 17.5 mg) and two independent retail listings all give 5x10⁹ / 5x10⁷. 278089's footnote is treated here as a transcription carryover and the 5 billion / 50 million figures are used. Flagged because a reader checking 278089 alone will see a different number than this page reports and deserves to know why.
How to check every line of this page yourself
Nothing on this page requires trusting us. Every claim above resolves to a record you can open:
- Open the NIH Dietary Supplement Label Database record linked at the top of this page. It is the label the manufacturer filed, not our transcription of it.
- Compare the CFU line and the suggested-use line against the disclosure table above. If they disagree with us, we are wrong and we want to know.
- Take any strain designator from the panel and run the query printed beside it. The query is published precisely so you can get a different answer than we did.
- Divide the price by the number of days the label’s own dose instructions make the container last. That arithmetic is the whole of the cost-per-day row.
- Search the certifier’s own register for this product, not for the brand. A company can participate in a programme without this product being on its list.
Align prints both ends of its potency curve, and the arithmetic between them is the story.
“Contains 5 x 10⁹ (five billion) live bacteria/CFU when manufactured, and provides an effective level of bacteria (5 x 10⁷ CFU) until at least the ‘best by’ date.”
Five billion at the factory. Fifty million guaranteed to best-by. A hundredfold gap — ninety-nine percent of the advertised dose is not guaranteed for any of the product’s shelf life. And the label carries the words “Guaranteed potency”. What is guaranteed is one percent of the number on the box.
The retail copy names the trick without meaning to: “guaranteed to deliver an effective level of probiotics through the best by date.” “An effective level” is the term of art doing all the work. The brand defines it. It is 1% of the headline.
Two smaller versions of the same move. The “5X more good bacteria” claim is 17.5 mg against regular-strength Align’s 4 mg — 4.4 times by mass, five times by at-manufacture CFU, which is the comparison point most favourable to the claim. And on Align’s own website the token “billion” appears zero times: the only potency statement is a ratio against the brand’s own weaker product, and the Supplement Facts exists only inside a JPEG. A shopper on the brand’s site cannot learn the dose in any unit at all.
None of which is a knock on the strain. Bifidobacterium longum subsp. longum 35624 is real, deposited (also NCIMB 41003 / UCC35624), and carries eight randomised controlled trials clustering on IBS. One of one disclosed strains is matchable to human evidence. The problem is that the guarantee is expressed at the floor, so whether a buyer ever receives a studied dose depends entirely on how old the box is — and nothing on the label lets them find out.
Then the claims that carry the persuasion. “#1 Doctor and #1 Gastroenterologist recommended probiotic brand” is a survey of what doctors recommend, not a trial of whether it works. “4 out of 5 people felt more confident with their digestive health” is footnoted to 1,612 of the brand’s own website reviews as of 31 March 2021. Feeling more confident about your digestive health is not having better digestive health.
And there is no price. Not on the brand’s own site — no price field, no cart, no buy button anywhere in the page payload. Being unable to price a #1-doctor-recommended pharmacy product from the company that makes it is its own finding about how this category works.