One product, one panel, one record.
Ortho Molecular Products Ortho Biotic 100 (SKU 474030 / 474060) — label audit
The entire premise of this product is that 100 billion CFU does something 20 billion cannot, and the only citation offered for a dose-threshold effect is an in-vitro dendritic-cell experiment on Lactobacillus rhamnosus Lcr35 — a strain that is not in the bottle.
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 Audited 2026-07-31, outside the frozen founding cohort of 27 and outside every D27 denominator.
- How deep this went
- Label audit — the lighter pass What the label says, what basis it gives for its CFU number, whether the strains are coded, whether a government label record exists — checked and published. No full claim inventory was written for this SKU. It is a real result, and it is a shallower one than the teardowns above it, which is why the page says so before you weigh it against them.
- What did not survive verification
- Part of this page was refuted or could not be reproduced The brand's current product-information sheet and the NIH Dietary Supplement Label Database disagree about what is in this product, and the disagreement could not be resolved. DSLD 174639 — flagged on-market, carrying this product's own SKU number and UPC — transcribes the Lactobacillus rhamnosus slot as Lr-32. The brand's current sheet (LT-PDN-044-D, panel V4) prints GG. The other five organisms are identical across both sources. This page publishes the current sheet's values because that is what the brand publishes today, but no reformulation claim is made or implied: what is quotable is only that the brand's own current sheet and the federal label database disagree about which L. rhamnosus strain this product contains. Resolving it needs a physical bottle or a statement from the brand, and neither was obtained. Separately, no brand price exists to verify — see the price note.
The Label Verifiability Score for this product
59.7 out of 100
Rank 72 of the 154 products in this audit the rubric can score. This rank is shared with 7 other products — 8 products sit on 59.7 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 | 6 of 6 organism slots carry a printed strain designator. | 6 / 6 = 1.0000 | 0.2400 |
| Per-organism amount printed | 0.20 | 0 of 6 organism slots have an amount of its own; the rest are inside a blend total. | 0 / 6 = 0.0000 | 0.0000 |
| What the CFU count is measured against | 0.22 | Potency basis "none-stated": CFU figure printed yes, single basis stated no, basis reaches expiry no — 1 of 3. | 1 / 3 = 0.3333 | 0.073333 |
| Printed designators that lead to a human trial | 0.20 | 6 of 6 checked organism slots resolve 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. | 6 / 6 = 1.0000 | 0.2000 |
| Certification confirmed at the issuer’s own register | 0.14 | No certifier register has been queried for this product. Not checked is not the same as holds nothing. | Not answered | — excluded from the divisor, not counted as nought |
0.513333 — the last column added up — divided by 0.86, the weight this record could answer, is 0.5969. Multiplied by 100 and rounded to one decimal, that is the 59.7 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 | Proprietary Blend 423 mg (100 Billion CFU) |
| What that count is measured against | No basis stated |
| Strain designators | All organisms coded |
| Organism slots transcribed here | 6 — the full panel |
| Marketed as | Unisex |
The panel prints "100 Billion CFU" with no temporal qualifier. The product page and product-information sheet contain only the generic sentence "For a probiotic to be effective, it must be shelf-stable through the expiration date" — a statement about probiotics in general, not a guarantee about this product. The brand's sibling SKU, Ortho Biotic Capsules, does carry "Guaranteed potency at expiration." This one does not.
The panel’s own words on potency, verbatim.
A CFU number appears with no temporal basis of any kind. A count with no basis is not a quantity; there is no date at which it is claimed to be true.
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 |
|---|---|---|---|---|
| Lactobacillus acidophilus | La-14 | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
| Lactobacillus paracasei | Lpc-37 | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
| Bifidobacterium bifidum | Bb-02 | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
| Bifidobacterium lactis | Bl-04 | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
| Lactobacillus plantarum | Lp-115 | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
| Lactobacillus rhamnosus | GG | — not stated separately | Human RCT | PubMed E-utilities, exact designator with randomized controlled trial[pt] |
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 174639 (opens in a new tab) captured On-market. "Ortho Biotic 100 Billion CFU", product #474030, UPC 6 15033 01474 2. This record transcribes L. rhamnosus as Lr-32, which the brand's current sheet does not.
- Dated capture of the brand’s own page — ompi-orthobiotic100-pdn-b2-LT-PDN-044-D-2026-07-31https://www.orthomolecularproducts.com/product/ortho-biotic-100 — Address given, not linked: this site does not link out to the products it audits. captured The Supplement Facts panel is not on the product page — the panel tab sits behind a practitioner login. The panel above was transcribed from the brand's own product-information sheet, ompi-orthobiotic100_pdn-b2.pdf, doc code LT-PDN-044-D, panel version V4, linked from the PDP and fetched directly. The PDP returned HTTP 200. Also declared on the panel: Calories 5, Total Carbohydrate under 1 g, Sodium 5 mg, Potassium 95 mg (2% DV). Other ingredients: microcrystalline cellulose, hypromellose, silicon dioxide, magnesium stearate. No S. boulardii — the label reads "free of ... yeast". This sheet is also the source of the eleven-item reference list in the findings.
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, 6 organism slots carry 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.
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 high-dose-1700-genes-claim-built-on-in-vitro-study-of-a-strain-not-in-the-product
Front of the product sheet, verbatim: "Shown to activate over 1,700 genes involved in immune and inflammatory signaling, high-dose probiotics improve immune function, maintain a healthy gut-immune barrier, and maintain normal inflammatory balance." The supporting citation is Evard B et al., "Dose-dependent immunomodulation of human dendritic cells by the probiotic Lactobacillus rhamnosus Lcr35", PLoS ONE 2011;6(4):e18735. Three problems, all checkable: the study is on Lcr35 and this product contains GG; it is human dendritic cells in vitro, not a human trial, and gene activation in cultured cells is not "improve immune function" in a person; and the product's entire premise — "Going beyond the threshold of traditional probiotic support, high-dose probiotics influence GI health and immunity in ways lower-dose probiotics cannot" — rests on it. The same claim with the same citation also appears on the 20-billion sibling SKU's sheet.
The record: Brand PDF ompi-orthobiotic100_pdn-b2.pdf, doc LT-PDN-044-D, front page and ref 11; PLoS ONE 2011;6(4):e18735 — open ithttps://www.orthomolecularproducts.com/product/ortho-biotic-100 — Address given, not linked: this site does not link out to the products it audits.
Finding 2 cfu-basis-unstated-while-the-sibling-sku-guarantees-potency-at-expiration
Ortho Biotic Capsules carries "Guaranteed potency at expiration." This product carries only the generic "For a probiotic to be effective, it must be shelf-stable through the expiration date." Same brand, same product family, same page template, same PDF format — the guarantee is present on one and absent on the other. A same-brand asymmetry with every confounder removed.
The record: Brand PDF LT-PDN-044-D versus LT-PDN-107-E, both read 2026-07-31
Finding 3 hundred-billion-cfu-with-zero-per-strain-allocation
Six organisms behind a single 423 mg, 100-billion-CFU proprietary blend. The largest opaque pool in its batch.
The record: Brand PDF LT-PDN-044-D, panel V4
Finding 4 not-one-of-eleven-references-is-a-human-rct-on-a-contained-strain
The B. lactis claim (refs 7, 8) cites NCC2818 while the product contains Bl-04. The L. plantarum claim (ref 10) cites Biocenol™ LP96 in gnotobiotic pigs while the product contains Lp-115. The L. paracasei claim (ref 4) cites NTU 101 while the product contains Lpc-37. The B. bifidum claim (ref 6) is Fooks and Gibson, mixed-culture fermentation — in vitro — while the product contains Bb-02. The L. acidophilus claim (ref 2) is the Danisco "probiotic identity card", a supplier marketing document. Ref 1 is Lipski E, "Digestive Wellness", 1996, a trade paperback. Of eleven references, not one is a human randomised trial on a strain this product actually contains.
The record: Brand PDF LT-PDN-044-D reference list, read 2026-07-31
Finding 5 bb-02-substituted-for-bb-06-versus-the-sibling-sku-undiscussed
The B. bifidum slot is Bb-02 here and Bb-06 in Ortho Biotic Capsules. Bb-02 has one RCT-tagged PubMed record; Bb-06 has two. Neither is well studied and the substitution is not mentioned anywhere.
The record: Brand PDFs LT-PDN-044-D and LT-PDN-107-E, panels compared 2026-07-31
Finding 6 most-expensive-per-day-in-its-batch-for-its-least-substantiated-feature
$2.45 per day at reseller pricing, the highest in its audit batch, for a formula whose distinguishing feature is a dose whose rationale rests on an in-vitro study of a strain that is not present.
The record: Oakway Naturals listing at $73.60 for 30 capsules, formula 474030, read 2026-07-31
Finding 7 vitasecure-and-vcaps-are-the-only-marks-and-neither-is-a-certification
No third-party certification is claimed. The Seals/Symbols entries are VitaSecure, Ortho Molecular's own product-authentication programme, and Vcaps, a Lonza capsule supplier brand. Free-from claims — "gluten, corn, yeast, artificial colors and flavors" — are self-declared with no certifier named. The label also carries "Professional Strength: Not for sale through Amazon.com."
The record: DSLD 174639 label transcription and brand PDF LT-PDN-044-D, 2026-07-31 — open it (opens in a new tab)
Finding 8 price-gated-behind-a-practitioner-login
A consumer cannot compare cost per day without going through a third-party reseller.
The record: orthomolecularproducts.com product page, login wall, 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.
- Third-party certification
- No certifier register has been queried for this product. An empty certification list on this page means not checked — it does not mean the product holds nothing.
- A US retail price, and therefore the cost per day
- Ortho Molecular does not publish a price. The product page requires a practitioner login, so no brand MSRP is retrievable. The only figure found is a third-party reseller price — Oakway Naturals at $73.60 for 30 capsules, a listing that confirms the count ("Ortho Biotic® 100 - 30 Capsules (Formula: 474030)") — which at the label's one-capsule serving works out to $2.45 per day on a reseller basis, the most expensive per day in its audit batch. A reseller price is not a brand MSRP and is not published here as this product's price, and no cost per day is derived from it.
- A men’s-versus-women’s label diff
- The same brand’s women’s SKU has not been compared against this panel.
- A brand MSRP, and therefore an authoritative cost per day
- Ortho Molecular gates price behind a practitioner login. See the price note.
- Which label is currently shipping
- DSLD 174639 (2018, on-market) transcribes L. rhamnosus as Lr-32; the brand's current sheet (LT-PDN-044-D, panel V4) prints GG. The disagreement can be proved; which label is on the shelf cannot be, without a physical bottle or a statement from the brand.
- How the 100 billion CFU is split across the six organisms
- Not disclosed. This is the largest undifferentiated CFU pool in its audit batch. The average is about 16.7 billion per organism, but nothing on the label prevents 99 billion of the cheapest one.
- Whether the high-dose premise has any human evidence behind it
- The product's distinguishing feature is its dose, and the only citation offered for a dose-threshold effect is an in-vitro dendritic-cell study of a strain the product does not contain. No human dose-response evidence for this formula was found or cited.
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.
Everything about this product is the dose. It is the sibling of a 20-billion SKU, it costs roughly twice as much per day, and the argument for the difference is printed on the front of its own sheet:
“Going beyond the threshold of traditional probiotic support, high-dose probiotics influence GI health and immunity in ways lower-dose probiotics cannot.”
The evidence offered for that threshold is a single citation, and it is worth naming precisely: Evard et al., PLoS ONE 2011, “Dose-dependent immunomodulation of human dendritic cells by the probiotic Lactobacillus rhamnosus Lcr35.” The strain is Lcr35. This product contains GG. The experiment is human dendritic cells in a dish, not people. Gene activation in cultured cells is not “improve immune function” in a person, and the same claim with the same citation is also printed on the 20-billion sibling’s sheet — where it is used to sell a lower dose.
Widen the lens and the pattern holds. Of the sheet’s eleven references, not one is a human randomised trial on a strain this product contains. The B. lactis claim cites NCC2818 (product has Bl-04). The L. plantarum claim cites Biocenol™ LP96, in gnotobiotic pigs (product has Lp-115). The L. paracasei claim cites NTU 101 (product has Lpc-37). The B. bifidum claim is an in-vitro fermentation study (product has Bb-02). The L. acidophilus claim is a supplier marketing document. And the general opener is a 1996 trade paperback.
The disclosure itself is a single 423 mg number holding 100 billion CFU across six organisms. On average that is about 16.7 billion each. Nothing on the label prevents 99 billion of the cheapest one.
The most useful comparison here needs no other brand. Ortho Biotic Capsules — same company, same product family, same page template, same PDF format — prints “Guaranteed potency at expiration.” This product prints only “For a probiotic to be effective, it must be shelf-stable through the expiration date”, which is a statement about probiotics as a class and a guarantee about nothing. One product makes the promise and the other does not, and every confounder a reader could raise about cross-brand comparisons is gone.