What is NDC 61269-881?

61269-881 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

H2-Pharma, LLC, NDC labeler code 61269. 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 61269-881 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61269-881Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61269-0881Add 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
61269-881-35	6126908813561269088135	2 g in 1 TUBE (61269-881-35)Marketed from Apr 10, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: H2-Pharma, LLCNDC labeler code 61269
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212385
Marketing start: Apr 10, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 61269-881_f2757843-0b78-46be-a22c-bcdf3a433464SPL ID f2757843-0b78-46be-a22c-bcdf3a433464SPL set ID f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5RxCUI 797534UNII 9G1OE216XY

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

N461269088135 followed by a unit qualifier and the quantity

Package 61269-0881-35. 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 Apr 14, 2025.

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 61269-881

What is NDC 61269-881?: 61269-881 is the product NDC for Docosanol, Docosanol 100 mg/g cream, listed with the FDA by H2-Pharma, LLC. It has 1 package NDC, 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?: H2-Pharma, LLC, NDC labeler code 61269. 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	YYBA Corp	73581-004	73581-0004-0273581-0004-0373581-0004-10+1 more
Docosanol	Docosanol 100 mg/g	CreamTopical	Amerisource Bergen	46122-800	46122-0800-36

All 36 Docosanol NDCs

Other NDCs under ANDA 212385

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

FDA NDC Directory listings under ANDA 212385
Product	Strength	Form · route	Labeler	Product NDC
Cold Sore Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	P & L Development, LLC	59726-112
Cold Sore Fever Blisterdocosanol	Docosanol 100 mg/g	CreamTopical	P & L Development, LLC	59726-221
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Meijer Distribution Inc.	79481-0065
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Safeway, Inc.	21130-605
Docosanol	Docosanol 100 mg/g	CreamTopical	H2-Pharma, LLC	61269-989
Cold Sore Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	P & L Development, LLC	59726-922
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Walgreens	0363-6510
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	The Kroger Co.	30142-869
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-859
Docosanol	Docosanol 100 mg/g	CreamTopical	AAFES/Your Military Exchanges	55301-112
Docosanol	Docosanol 100 mg/g	CreamTopical	Care One (Retail Business Services, LLC.)	72476-965
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	TARGET Corporation	11673-769
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Strategic Sourcing Services LLC	70677-1255
Docosanol	Docosanol 100 mg/g	CreamTopical	Encube Ethicals, Inc.	21922-023
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	WALMART INC. (see also Equate)	79903-248
Docosanol	Docosanol 100 mg/g	CreamTopical	Safeway, Inc.	21130-770
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Sportpharm LLC	85766-239
Cold Sore Fever Blisterdocosanol	Docosanol 100 mg/g	CreamTopical	H E B	37808-661
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	55910-550
Cold Sore Fever Blister Treatmentdocosanol	Docosanol 100 mg/g	CreamTopical	H E B	37808-765

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