Application 208754

Type: ANDA
Sponsor: P AND L

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOCOSANOL	DOCOSANOL	CREAM;TOPICAL	10%	No	No

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…`

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 ndc (product): 0363-9222
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 ndc (product): 30142-981
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 ndc (product): 11673-846
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 ndc (product): 0363-9220
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 ndc (product): 41163-724
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 ndc (product): 55910-963
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 ndc (product): 49035-259
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 ndc (product): 55301-877
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 ndc (product): 21130-823

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 105 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0300	ABREVA	docosanol	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0135-0300	ABREVA	docosanol	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreens	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreens	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreens	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreens	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreen Company	ANDA	Current
0363-2981	Docosanol	Docosanol	Walgreens	ANDA	Current
0363-9220	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9220	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9222	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9222	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9222	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9222	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0363-9222	Cold Sore Fever Blister Treatment	Docosanol	Walgreens	ANDA	Current
0472-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0472-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0472-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0591-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0591-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0591-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
0591-2981	Docosanol	Docosanol	Actavis Pharma, Inc.	ANDA	Current
11673-846	Cold Sore Fever Blister Treatment	Docosanol	TARGET Corporation	ANDA	Current
11673-846	Cold Sore Fever Blister Treatment	Docosanol	TARGET Corporation	ANDA	Current
11673-926	Cold Sore Fever Blister Treatment	Docosanol	TARGET Corporation	ANDA	Current
11673-926	Cold Sore Fever Blister Treatment	Docosanol	TARGET Corporation	ANDA	Current
11673-926	Cold Sore Fever Blister Treatment	Docosanol	TARGET Corporation	ANDA	Current
11822-0951	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-0951	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-0951	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3927	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3927	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3927	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3951	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3951	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-3977	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
11822-4763	Cold Sore Fever Blister Treatment	Docosanol	Rite Aid Corporation	ANDA	Current
21130-422	Docosanol	Docosanol	Safeway, Inc.	ANDA	Current
21130-422	Docosanol	Docosanol	Safeway, Inc.	ANDA	Current
21130-422	Docosanol	Docosanol	Safeway, Inc.	ANDA	Current
21130-823	Cold Sore Fever Blister Treatment	Docosanol	Safeway, Inc.	ANDA	Current
21130-823	Cold Sore Fever Blister Treatment	Docosanol	Safeway, Inc.	ANDA	Current
30142-322	Cold Sore Fever Blister	Docosanol	The Kroger Co.	ANDA	Current
30142-322	Cold Sore Fever Blister	Docosanol	The Kroger Co.	ANDA	Current
30142-322	Cold Sore Fever Blister	Docosanol	The Kroger Co.	ANDA	Current
30142-981	Cold Sore Fever Blister Treatment	Docosanol	The Kroger Co.	ANDA	Current
30142-981	Cold Sore Fever Blister Treatment	Docosanol	The Kroger Co.	ANDA	Current
37808-223	Cold Sore Fever Blister	Docosanol	H E B	ANDA	Current
37808-223	Cold Sore Fever Blister	Docosanol	H E B	ANDA	Current
37808-229	Cold Sore Treatment	Docosanol	H E B	ANDA	Current
37808-229	Cold Sore Treatment	Docosanol	H E B	ANDA	Current
37808-229	Cold Sore Treatment	Docosanol	H E B	ANDA	Current
41163-722	Docosanol	Docosanol	EQUALINE (SuperValu)	ANDA	Current
41163-722	Docosanol	Docosanol	EQUALINE (SuperValu)	ANDA	Current
41163-722	Docosanol	Docosanol	EQUALINE (SuperValu)	ANDA	Current
41163-724	Docosanol	Docosanol	EQUALINE (SuperValu)	ANDA	Current
41163-724	Docosanol	Docosanol	EQUALINE (SuperValu)	ANDA	Current
41250-867	Docosanol	Docosanol	MEIJER, INC.	ANDA	Current
41250-867	Docosanol	Docosanol	MEIJER, INC.	ANDA	Current
41250-932	Docosanol	Docosanol	MEIJER, INC.	ANDA	Current
41250-932	Docosanol	Docosanol	MEIJER, INC.	ANDA	Current
46122-624	Docosanol	Docosanol	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-624	Docosanol	Docosanol	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-681	Docosanol	Docosanol	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-681	Docosanol	Docosanol	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
46122-681	Docosanol	Docosanol	AmerisourceBergen (Good Neighbor Pharmacy) 46122	ANDA	Current
49035-259	Docosanol	Docosanol	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
49035-259	Docosanol	Docosanol	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ANDA	Current
49035-259	Docosanol	Docosanol	EQUATE (Wal-Mart Stores, Inc.)	ANDA	Current
55301-877	Docosanol	Docosanol	AAFES/Your Military Exchanges	ANDA	Current
55301-877	Docosanol	Docosanol	AAFES/Your Military Exchanges	ANDA	Current
55301-922	Docosanol	Docosanol	AAFES/Your Military Exchanges	ANDA	Current
55301-922	Docosanol	Docosanol	AAFES/Your Military Exchanges	ANDA	Current
55301-922	Docosanol	Docosanol	AAFES/Your Military Exchanges	ANDA	Current
55910-722	Docosanol	Docosanol	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-722	Docosanol	Docosanol	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
55910-963	Cold Sore Fever Blister Treatment	Docosanol	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ANDA	Current
59726-924	Cold Sore Treatment	Docosanol	P & L Development, LLC	ANDA	Current
59726-924	Cold Sore Treatment	Docosanol	P & L Development, LLC	ANDA	Current
61269-981	DOCOSANOL	DOCOSANOL	H2-Pharma, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56857	ORIG	2018-12-20