Docosanol

Product NDC: 62011-0433
11-digit product format: 620110433
Labeler code: 62011
Product ID: 62011-0433_5174f877-30bf-47d7-8b88-0b34f713e1a0
Type: HUMAN OTC DRUG
Nonproprietary name: Docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: Strategic Sourcing Services LLC
Application: ANDA208754
Marketing category: ANDA
Marketing start: 2019-10-30
Marketing end: 2026-12-30
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Current FDA listing: Yes

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: Yes
Brand name base: Docosanol

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCOSANOL	100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9G1OE216XY	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797534	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3faf583c-90d2-4620-93ea-d763191ab452	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62011-0433-1	Docosanol	2 g in 1 TUBE	CREAM	2		4
62011-0433-1	Docosanol	1 in 1 PACKAGE	CREAM	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0433-1	GM - Gram	62011-0433	4ae64934-2bca-45bd-848b-2249b695f9a1	1	2021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0433	DOCOSANOL CREAM [STRATEGIC SOURCING SERVICES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231021_3faf583c-90d2-4620-93ea-d763191ab452.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
797534	docosanol 10 % Topical Cream	PSN	3faf583c-90d2-4620-93ea-d763191ab452	4
797534	docosanol 100 MG/ML Topical Cream	SCD	3faf583c-90d2-4620-93ea-d763191ab452	4
797534	docosanol 10 % Topical Cream	SY	3faf583c-90d2-4620-93ea-d763191ab452	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62011-0433-1	62011043301	1 TUBE in 1 PACKAGE (62011-0433-1) / 2 g in 1 TUBE	1 tube	2019-10-30	2026-12-30	No	No	Current