OTC Drug Listing with FDA (NDC), per SKU
FDA drug listing and NDC assignment for each OTC product and pack size.
- 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
Each OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug listing SPL with your labeler code, product code and package codes, including the Drug Facts label, and submit it. Your establishment must already be registered. Testing is excluded. £395 per SKU.
What's included in your drug listing
| Document | What it is |
|---|---|
| NDC assignment | Product and package codes built on your labeler code |
| Listing SPL | Active ingredients, dosage form, route and monograph |
| Label upload | Drug Facts label and packaging included in the SPL |
| Submission | Through FDA's electronic system |
Who this listing is for
- Brands with a registered OTC drug establishment
- Sellers of sunscreen, acne, antiperspirant and anti-dandruff products
- Brands adding new SKUs or pack sizes
What this listing does not include
- Laboratory testing. Laboratory testing, lab fees and test reports are not included.
- Establishment registration and labeler code. Available separately.
- Drug Facts label review. Available separately.
- FDA fees. Any FDA OMUFA facility fee is extra and passed through at cost; the current amount is confirmed at order.
How it works
- Send your product Formula, labels and pack sizes.
- Prepare We assign codes and build the listing SPL.
- Submit We submit the listing.
- Confirmed We send your NDCs. FDA processing time varies and is outside our control, so we do not guarantee a date.
What is OTC drug listing?
Under 21 CFR Part 207, each drug in US commercial distribution must be listed with FDA, and each product and pack receives a National Drug Code (NDC). For OTC monograph drugs like sunscreens and acne treatments, the listing names the active ingredients, the monograph and the Drug Facts label. Listings are updated each June and December when information changes.
What the listing contains
Product data:
- Active and inactive ingredients.
- Dosage form and route.
- Monograph or marketing category.
Packaging:
- Package NDCs for each pack size.
- Label and carton images.
What you receive
- NDC for the product and each pack size
- Submitted listing SPL
- A reminder of the June and December update windows
Legal framework
- FD&C Act section 510(j) — drug listing
- 21 CFR Part 207 — listing and NDC format
- 21 CFR 201.66 — Drug Facts labelling
Official sources:
Why brands choose Phoenix
- NDCs set up correctly from the start.
- Works with our registration and label services.
- Reviewed by Syed Muhammad Shamuel Shees, US Regulatory Lead.
List each SKU before you sell. Order above, or message us on WhatsApp on +44 7346 009332.
Frequently asked questions
Does every OTC product need an NDC?
Yes. Each drug listed with FDA receives an NDC, with a package code for each pack size.
Do I need establishment registration first?
Yes. The establishment must be registered and have a labeler code before products are listed.
Is the price per product?
Yes. £395 per SKU.
Is testing included?
No. Laboratory testing, lab fees and test reports are not included.
When must listings be updated?
In June and December each year if the listing information has changed.
Does an NDC mean FDA approval?
No. An NDC and listing do not mean FDA has approved the product.