What is NDC 0713-0353?

0713-0353 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Docosanol?

35 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Docosanol NDC 0713-0353 | National Drug Code

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	0071303530200713035302	1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBEMarketed from Jan 4, 2024
0713-0353-62	0071303536200713035362	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.NDC labeler code 0713
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, 2027
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)

About NDC 0713-0353

What is NDC 0713-0353?: 0713-0353 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Docosanol.
What is the active ingredient?: Docosanol.
Who is the labeler?: Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Docosanol?: 35 other product NDCs are listed under this name. See all Docosanol NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Docosanol NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Docosanol	Docosanol 100 mg/g	CreamTopical	BIONPHARMA INC.	69452-550	69452-0550-0269452-0550-61
Docosanol	Docosanol 100 mg/g	CreamTopical	Dr.Reddys' Laboratories Inc	43598-946	43598-0946-0243598-0946-1343598-0946-22
Docosanol	Docosanol 100 mg/g	CreamTopical	Dr.Reddys' Laboratories Inc	43598-044	43598-0044-0243598-0044-33
Docosanol	Docosanol 100 mg/g	CreamTopical	KLM Laboratories Private Limited	84725-001	84725-0001-0184725-0001-0284725-0001-09
Docosanol	Docosanol 100 mg/g	CreamTopical	Leader/ Cardinal Health 110, Inc.	70000-0743	70000-0743-01
Docosanol	Docosanol 100 mg/g	CreamTopical	WALMART INC. (see also Equate)	79903-402	79903-0402-1079903-0402-20
Docosanol	Docosanol 100 mg/g	CreamTopical	Publix Super Markets Inc.	41415-660	41415-0660-03
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-682	46708-0682-0146708-0682-03
Docosanol	Docosanol 100 mg/g	CreamTopical	H2-Pharma, LLC	61269-881	61269-0881-35
Docosanol	Docosanol 100 mg/g	CreamTopical	YYBA Corp	73581-004	73581-0004-0273581-0004-0373581-0004-10+1 more

All 36 Docosanol NDCs

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	Rugby Laboratories	0536-1427
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Limited	46708-682
Docosanol	Docosanol 100 mg/g	CreamTopical	CVS Pharmacy, Inc.	51316-763
Docosanol	Docosanol 100 mg/g	CreamTopical	Alembic Pharmaceuticals Inc.	62332-682
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