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Health Care (OTC drugs)

Amazon OTC drug listing compliance, checked before Amazon checks it

Checked against FDA OTC monographs, Drug Facts and NDC rules, the FTC, and CPSC child-resistant packaging rules.

Health Care (OTC drugs)
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  • Never connects to Seller Central
  • Every finding cites its rule
  • 14-day trial on every plan
Health Care (OTC drugs) product from the Verid8 test catalog
OTCImage 2 · label
Critical

Label shows NDC 71234-008-01; no match in FDA’s NDC Directory.

NDC not found in FDA’s NDC Directory
§ 21 CFR Part 207 · live NDC check
Suggested rewriteList the product with FDA, or use the NDC FDA has on file.

Which OTC drug products does Verid8 cover?

Verid8 detects each product’s sub-type and applies the rules for it. If it can’t tell, it asks you.

  • Sunscreen
  • Hand sanitizer
  • Acne
  • Pain relief
  • Antiperspirant
  • First aid
  • Homeopathic
  • SPF moisturizers
  • SPF lip balm
Coverage

What does Verid8 check on an OTC drug listing?

01

Listing copy and claims

  • Claims outside the Drug Facts “Uses”
  • Prohibited sunscreen terms: “sunblock”, “waterproof”
  • Kill-rate and disease-prevention claims on antiseptics
  • Claims beyond the monograph
02

Label and images

  • Drug Facts panel, section by section
  • NDC
  • Expiration date and lot
  • SPF and broad-spectrum statements
03

Documents and obligations

  • FDA establishment registration
  • NDC listing
  • SPF and broad-spectrum test reports
  • Certificate for child-resistant packaging
Example findings

What does a scan catch in OTC drug listings?

Real findings from our planted-violation test listings. The brands are fictitious; the rules are not.

OTCImage 2 · label
Critical

Label shows NDC 71234-008-01; no match in FDA’s NDC Directory.

NDC not found in FDA’s NDC Directory
§ 21 CFR Part 207 · live NDC check
Suggested rewriteList the product with FDA, or use the NDC FDA has on file.
OTCTitle
High

SPF 50 Waterproof Sunblock Lotion, 6 oz

Prohibited sunscreen terms
§ 21 CFR 201.327(g)
Suggested rewriteSPF 50 Broad Spectrum Sunscreen Lotion, Water Resistant (80 minutes), 6 oz
OTCBullet 1
High

Kills 99.99% of germs and prevents the flu.

Claim outside the Drug Facts Uses
§ 21 CFR 201.66(c)(4)
Suggested rewriteHand sanitizer to help reduce bacteria that potentially can cause disease.
OTCImage 5 · Drug Facts
Medium

Drug Facts image is missing “Inactive ingredients”.

Incomplete Drug Facts panel
§ 21 CFR 201.66(c)
Suggested rewriteShow the complete Drug Facts panel in the gallery.
Amazon

What does Amazon require for OTC drug listings?

The main Amazon requirements for this category. Verid8 checks the listing side of each one.

Check in Seller Central ↗
Drug Facts imagesAmazon asks for images of the full Drug Facts panel so shoppers can read it before buying.
Expiration datesOTC products need an expiration date and enough remaining shelf life to be received at FBA.
Restricted productsPrescription drugs and products FDA has warned about can’t be listed.
Dangerous goods reviewAlcohol-based sanitizers and aerosol sunscreens are flammable, so Amazon asks for a safety data sheet.
Rules and sources

Which regulators and rules apply?

FDAOTC monographs (CARES Act, 2020)What each OTC category may claimFDA21 CFR 201.66Drug Facts labelingFDA21 CFR 201.327Sunscreen labeling and testingFDA21 CFR Part 207Establishment registration and NDCFTCFTC Act §5Deceptive advertisingCPSCPPPA · 16 CFR 1700Child-resistant packaging
Related rulesEach rule gets its own page in the public rule library: the rule in plain English, its source, and a violating and a compliant example.
FAQ

OTC compliance questions

Does a sunscreen listing need a Drug Facts label?

Yes. Sunscreens are OTC drugs in the US, so the label and the listing images must show a complete Drug Facts panel.

Why can’t I call my sunscreen “sunblock” or “waterproof”?

FDA bars both terms on sunscreen labels (21 CFR 201.327(g)), because no sunscreen blocks all UV or is fully waterproof. Use “water resistant (40 or 80 minutes)” if the product passed that test.

Does my OTC product need an NDC?

Yes. OTC drugs must be listed with FDA, and the listing gives the product its NDC. Verid8 checks each NDC live against FDA’s NDC Directory.

Can a hand sanitizer say it kills 99.99% of germs?

Not as a stand-alone claim. The listing should match the Drug Facts Uses, and FDA has warned sellers about kill-rate and disease-prevention claims.

What is an establishment registration?

The facility that makes or relabels an OTC drug must register with FDA and renew every year. Verid8 tracks the registration and its renewal date.

Does Verid8 read the Drug Facts panel?

Yes. It reads the panel from your images and checks each section, and the claims in your copy, against it.

Related guides

All guides →
GuideAmazon Sunscreen Listings: The SPF Claims 21 CFR 201.327 ForbidsGuideAmazon's Document Request for OTC Pain Relievers: GCC, PPPA and ISO 17025GuideHand Sanitizer on Amazon: Why Kills 99.9% of Germs Gets FlaggedGuideThe NDC on Your Amazon OTC Listing: What FDA and Amazon Each Require
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