Docosanol

Product NDC: 0591-2981
11-digit product format: 005912981
Labeler code: 0591
Product ID: 0591-2981_294a4de8-ef94-4cdc-aa5d-d9683bee59ca
Type: HUMAN OTC DRUG
Nonproprietary name: Docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: Actavis Pharma, Inc.
Application: ANDA208754
Marketing category: ANDA
Marketing start: 2019-04-05
Marketing end: 2022-10-31
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
unfinished product	product	0591-2981		UNFINISHED	Active or certified unfinished drug listing	2026-10-12
unfinished package	package	0591-2981	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	2026-10-12
excluded product	product	0591-2981		D	Discontinued by firm	2026-10-12
excluded package	package	0591-2981	0591-2981-35	D	Discontinued by firm	2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 54 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f268b84574a6…`	`26285f5ac5df…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`27f29a85d7e4…`	`1372111e901f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0591-2981-35	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	0591-2981-00	UNFINISHED	Active or certified unfinished drug listing	unfinished / ndc_unfinished.zip	`906f6e251498…`	`bf70b80e44f0…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-10-28 04:53 UTC	2022-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCOSANOL	100 mg/g

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2981-35	GM - Gram	0591-2981	3e9f6052-f043-4b94-b4fe-808504e6701e	1	2019-04-11

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
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
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
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
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
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

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
0591-2981-00	00591298100	1080 TUBE in 1 BOX (0591-2981-00) / 2 g in 1 TUBE	1080 tube	05-APR-19				Current
0591-2981-35	00591298135	1 TUBE in 1 PACKAGE (0591-2981-35) > 2 g in 1 TUBE	1 tube	2019-04-05	2022-10-31	No	No	Current