DOCOSANOL

Product NDC: 61269-981
11-digit product format: 612690981
Labeler code: 61269
Product ID: 61269-981_eb9407e5-ced9-48f1-aecd-ae40906d50da
Type: HUMAN OTC DRUG
Nonproprietary name: DOCOSANOL
Dosage form: CREAM
Route: TOPICAL
Labeler: H2-Pharma, LLC
Application: ANDA208754
Marketing category: ANDA
Marketing start: 2021-06-29
Marketing end: 0000-00-00
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61269-981		D	Discontinued by firm		2026-08-03
excluded package	package	61269-981	61269-981-35	D	Discontinued by firm		2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208754-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2018-11-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61269-981-35	GM - Gram	61269-981	3e51d098-b6b3-4f41-9a41-0e9befe0b50f	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61269-981	DOCOSANOL CREAM [H2-PHARMA, LLC]	3	Legacy NDC	20250413_a921a653-aedd-43c2-b84f-429a4aada79a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	ac3280b7-00aa-46cd-84e2-0a11992028ab	2026-07-09	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	The Kroger Co.	42b46e02-4d1f-411e-be9e-227f62ba5a86	2026-06-23	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	WALMART INC. (see also Equate)	f283ffd8-860a-4e97-8e22-94b907f75c8d	2026-04-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	P & L Development, LLC	e88e49b9-c292-48c5-b19e-630ffa6447e7	2026-04-02	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	45cfa88b-8146-4349-99cc-beec70455709	2026-02-18	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	TARGET Corporation	f68bd51a-9166-47a1-81f7-e379a93ab823	2026-01-22	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	a578c749-4264-4d5c-9357-ed482a04fb8b	2026-01-15	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	73178cbc-21f8-4fc1-8d31-50601f10dbd4	2025-12-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	e06fd4cf-cd92-4cae-94b7-abab95e97ebd	2025-12-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	United Natural Foods, Inc. dba UNFI	7dd527af-878c-4150-86d0-69881b5e3f8f	2025-11-17	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4286c19b-8c81-40f6-8d97-cfebba87c174	2025-10-10	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Family Dollar (FAMILY WELLNESS)	40297d6b-1096-467b-906c-701959884566	2025-10-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Topco Associates	65351744-0438-4416-ae1f-9169fc21d813	2025-09-11	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Strategic Sourcing Services LLC	3faf583c-90d2-4620-93ea-d763191ab452	2025-09-09	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	b62ee383-631a-4220-8dfd-48ec67bb0a63	2025-09-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	cb2c7675-8045-4c38-8479-7d819d808664	2025-08-22	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Best Choice (Valu Merchandisers Company)	ea458b65-8144-4671-857a-33b19c453e05	2025-08-21	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Chain Drug Consortium, LLC	86406372-9e95-43b9-b275-5661141a085b	2025-06-26	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	AAFES/Your Military Exchanges	b056ad46-bf48-4468-8b65-9e80176b6c52	2025-05-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Safeway, Inc.	5871e578-d16e-4f07-a32e-5263f9ca0a6a	2024-08-21	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9G1OE216XY	DOCOSANOL	661-19-8	DOCOSANOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61269-981-35	61269098135	1 TUBE in 1 PACKAGE (61269-981-35) > 2 g in 1 TUBE	1 tube	2021-06-29	0000-00-00	No	No	Current