OTC Drug Establishment Registration + Labeler Code (FDA)
FDA drug establishment registration and labeler code request for makers of OTC drugs such as sunscreens and acne products.
- Signed by a qualified safety assessor
- Regulator-ready, or we revise it free
- Delivered in 24, 48 or 72 hours
Trusted by brands including
Service details
Everything included, explained
Quick answer
Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them must register with FDA and obtain a labeler code before listing products. We prepare and submit both as SPL files through FDA's electronic system. FDA fees and laboratory testing are extra. £1,450.
What's included in your establishment registration
| Document | What it is |
|---|---|
| Product check | Confirms your products are OTC drugs and the relevant monograph |
| Labeler code request | Prepared and submitted as an SPL file |
| Establishment registration | Prepared and submitted as an SPL file |
| US agent check | Confirms the US agent for a foreign establishment |
| Annual renewal date | Registration renewed each year, 1 October to 31 December |
Who this service is for
- Manufacturers of sunscreen, acne, antiperspirant and anti-dandruff products
- UK and EU brands making SPF products for the US
- Amazon US sellers asked for drug registration
What this service does not include
- Laboratory testing. Laboratory testing, lab fees and test reports are not included. SPF and other monograph tests are arranged separately.
- FDA fees. Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.
- Product (NDC) listings. Available separately per SKU.
- A US agent. Foreign establishments need one; available on request.
- FDA approval. FDA does not issue registration certificates or verification letters, and registration or listing is not FDA approval.
How it works
- Send your details Establishment, products, formulas and DUNS number.
- Check We confirm the products are OTC monograph drugs.
- Submit We submit the labeler code request and the establishment registration.
- Confirmed We send your labeler code and registration confirmation. FDA processing time varies and is outside our control, so we do not guarantee a date.
What is OTC drug establishment registration?
Under FD&C Act section 510 and 21 CFR Part 207, establishments that manufacture, repack or relabel drugs for the US must register with FDA and list each drug. Many personal-care products are OTC monograph drugs: sunscreens, acne treatments with benzoyl peroxide or salicylic acid, antiperspirants and anti-dandruff products. Registration is made in Structured Product Labeling (SPL) format, and a labeler code is needed before NDC listing. Foreign establishments must name a US agent.
What we submit
Labeler code:
- Company details and DUNS number.
Establishment registration:
- Establishment name, address and DUNS.
- Business operations such as manufacture or relabel.
- US agent and importer for foreign establishments.
What you receive
- Labeler code once assigned
- Establishment registration confirmation
- SPL files submitted
- Annual renewal date
Legal framework
- FD&C Act section 510 — drug establishment registration and listing
- 21 CFR Part 207 — registration, listing and NDC rules
- FD&C Act section 505G — OTC monograph drugs
- FD&C Act section 744M — OTC monograph drug user fees (OMUFA)
Official sources:
Why brands choose Phoenix
- Cosmetic or drug check first — so you register correctly.
- SPL prepared for you.
- Clear about fees and testing before you order.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
Selling SPF or acne products in the US? Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Is sunscreen a cosmetic or a drug in the US?
A drug. Sunscreens are OTC monograph drugs, so the establishment must register with FDA and list each product.
What is a labeler code?
The first part of a National Drug Code. FDA assigns it to the company before products can be listed.
Are FDA fees included?
No. Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
How often must drug establishment registration be renewed?
Every year, between 1 October and 31 December.
How much does the service cost?
£1,450 per establishment. FDA processing time varies and is outside our control, so we do not guarantee a date.