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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`caaa826d4ba7…`
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…`

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABREVA	DOCOSANOL	Haleon US Holdings LLC	bf02c8c5-af60-41f1-a202-38a97491a720	2024-06-20	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Treatment	DOCOSANOL	H E B	a94bc3d7-3bc5-4ed6-9bc9-46df1e2c3c2d	2023-10-12	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister	DOCOSANOL	H E B	d9c5f237-62a2-4cba-920d-2c7aa0434b0e	2023-10-12	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Care One (Retail Business Services, LLC.)	c3f386e2-68da-4d64-809a-e170d473731d	2023-10-05	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754 ndc (product): 72476-922
Docosanol	DOCOSANOL	MEIJER, INC.	3eb9cf4a-4be8-4648-b63c-2eb7377588cf	2023-06-06	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Meijer Distribution Inc.	15c51055-2a07-4a0f-b140-89af34aa90db	2023-06-06	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754 ndc (product): 79481-9220
Cold Sore Fever Blister Treatment	DOCOSANOL	FSA Store Inc. (Caring Mills)	c17cc31f-bd2e-4da2-bba4-54b6b8b1ebf7	2022-12-01	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754 ndc (product): 81522-923
Cold Sore Treatment	DOCOSANOL	FSA Store Inc. (Caring Mills)	a46e4d60-e84b-44a9-9d54-4861dbe91c59	2022-12-01	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754 ndc (product): 81522-922
Docosanol	DOCOSANOL	Care One (Retail Business Services, LLC.)	3587f8f0-99ab-4493-adde-0dfd0911170d	2022-10-21	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754 ndc (product): 72476-492
Cold Sore Treatment	DOCOSANOL	P & L Development, LLC	15d1a6c5-4a61-48f3-b45e-a7e34cbeb294	2022-10-18	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
62011-0433	Docosanol	Docosanol	Strategic Sourcing Services LLC	ANDA	Current
62011-0433	Docosanol	Docosanol	Strategic Sourcing Services LLC	ANDA	Current
68016-052	Docosanol	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
68016-052	Docosanol	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
68016-052	Docosanol	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
68016-052	Docosanol	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
68016-344	Cold Sore Fever Blister Treatment	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
68016-344	Cold Sore Fever Blister Treatment	Docosanol	Chain Drug Consortium, LLC	ANDA	Current
70000-0517	Docosanol	Docosanol	Cardinal Health (Leader) 70000	ANDA	Current
70000-0517	Docosanol	Docosanol	Cardinal Health (Leader) 70000	ANDA	Current
70000-0517	Docosanol	Docosanol	Cardinal Health (Leader) 70000	ANDA	Current
72476-492	Docosanol	Docosanol	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-492	Docosanol	Docosanol	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-922	Docosanol	Docosanol	Care One (Retail Business Services, LLC.)	ANDA	Current
72476-922	Docosanol	Docosanol	Care One (Retail Business Services, LLC.)	ANDA	Current
76162-900	Cold Sore Fever Blister Treatment	Docosanol	Topco Associates	ANDA	Current
79481-9220	Cold Sore Fever Blister Treatment	Docosanol	Meijer Distribution Inc.	ANDA	Current
79903-011	Docosanol	Docosanol	WALMART INC.	ANDA	Current
79903-011	Docosanol	Docosanol	WALMART INC.	ANDA	Current
79903-011	Docosanol	Docosanol	WALMART INC. (see also Equate)	ANDA	Current
79903-118	Docosanol	Docosanol	WALMART INC.	ANDA	Current
81522-922	Cold Sore Treatment	Docosanol	FSA Store Inc.	ANDA	Current
81522-922	Cold Sore Treatment	Docosanol	FSA Store Inc. (Caring Mills)	ANDA	Current
81522-923	Cold Sore Fever Blister Treatment	Docosanol	FSA Store Inc.	ANDA	Current
81522-923	Cold Sore Fever Blister Treatment	Docosanol	FSA Store Inc. (Caring Mills)	ANDA	Current

Documents#

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