Docosanol NDC 0713-0353

NDC codes

FDA NDC Directory

Product NDC (as listed)0713-0353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00713-0353Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0713-0353-02	00713035302	1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBEMarketed from Jan 4, 2024
0713-0353-62	00713035362	1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMPMarketed from Jan 4, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Docosanol
Generic name (nonproprietary): docosanol
Active ingredients: Docosanol — 100 mg/g
Dosage form: Cream
Route: Topical
Labeler: Cosette Pharmaceuticals, Inc.
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215839
Marketing start: Jan 4, 2024
Listing expires: Dec 31, 2026
Identifiers: Product ID 0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4SPL ID e4d903b2-6585-4e80-a58e-128fe69cf1d4SPL set ID ccbb5e6d-cb85-449c-a480-28225d744f4dRxCUI 797534UNII 9G1OE216XYUPC 0307130353021

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400713035302 followed by a unit qualifier and the quantity

Package 00713-0353-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 4, 2024.

Indications (excerpt from the label)

Uses • treats cold sores/fever blisters on the face or lips • shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215839

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 215839
Product	Strength	Form · route	Labeler	Product NDC
Docosanol	Docosanol 100 mg/g	CreamTopical	CVS Pharmacy, Inc.	51316-763
Docosanol	Docosanol 100 mg/g	CreamTopical	Rugby Laboratories	0536-1427
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-682
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-682
Docosanol	Docosanol 100 mg/g	CreamTopical	Leader/ Cardinal Health 110, Inc.	70000-0672
Docosanol	Docosanol 100 mg/g	CreamTopical	Leader/ Cardinal Health 110, Inc.	70000-0743