Application 212385

Type: ANDA
Sponsor: ENCUBE

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
A212385-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2022-10-07

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.

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	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a50c72e98297…`

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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Sore Fever Blister Treatment	DOCOSANOL	Sportpharm LLC	e3e6c0b0-399f-41e4-9df9-109ee2917995	2026-07-12	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	518bd432-f0d0-4fc4-944c-b9d1a01e2064	2026-07-09	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Treatment	DOCOSANOL	P & L Development, LLC	53cd18dc-bece-473e-a116-df6c88fe6fe7	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Topco Associates	73348ce7-5b08-49ad-ba59-6f54887f819b	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Docosanol	DOCOSANOL	Care One (Retail Business Services, LLC.)	9f31b742-4170-4219-80e3-2a5a71b3483e	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Safeway, Inc.	85bfd33e-9404-4483-b76c-0ee519aad731	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	FSA Store Inc. (Caring Mills)	fe67f56e-4c35-40cb-8a75-174a873f2900	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister	DOCOSANOL	H E B	71b2bb18-4a48-42c2-b03a-dccf581a0d97	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ecf678b-d08a-4082-9d01-4468865a94b2	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Strategic Sourcing Services LLC	8a6bb379-bc3a-4ad2-9ecd-8fe1870873d8	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	TARGET Corporation	b332d558-bbe0-4d62-a51f-f07a228e6dca	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Docosanol	DOCOSANOL	Walgreens	1500df4d-0c69-4590-a67f-d11edcccd90c	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	WALMART INC. (see also Equate)	fe56bf08-1efd-4996-a276-06b6039085f3	2025-12-29	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Treatment	DOCOSANOL	P & L Development, LLC	20d2480b-44b5-499f-8670-01d6a4e4cb34	2025-12-05	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Docosanol	DOCOSANOL	Encube Ethicals, Inc.	5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd	2025-09-08	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385 ndc (product): 21922-023
DOCOSANOL	DOCOSANOL	H2-Pharma, LLC	f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5	2025-04-14	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Docosanol	DOCOSANOL	AAFES/Your Military Exchanges	11272b21-295d-49b3-83bf-5f71899340c5	2025-03-07	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister	DOCOSANOL	P & L Development, LLC	a71d2510-03c7-4724-b77b-12dd6451eb98	2025-01-03	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	The Kroger Co.	07fc9c8d-dee7-4a69-bb7a-0f3001a4ebb3	2024-10-17	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Docosanol	DOCOSANOL	Safeway, Inc.	d5ba34f8-42ab-4997-b06b-ea4e754b44d1	2024-08-21	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21922-023	Docosanol	Docosanol	Encube Ethicals Private Limited	ANDA	Current