DOCOSANOL

Product NDC: 0713-0353
11-digit product format: 007130353
Labeler code: 0713
Product ID: 0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4
Type: HUMAN OTC DRUG
Nonproprietary name: Docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: Cosette Pharmaceuticals, Inc.
Application: ANDA215839
Marketing category: ANDA
Marketing start: 2024-01-04
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A215839-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2022-05-03

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
2026-08-18 06:07:40	2026-07	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215839-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-05-03	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: DOCOSANOL
Listing expiration: 2026-12-31

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
ccbb5e6d-cb85-449c-a480-28225d744f4d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0713-0353-02	DOCOSANOL	2 g in 1 TUBE	CREAM	2	1
0713-0353-02	DOCOSANOL	1 in 1 CARTON	CREAM	1	1
0713-0353-62	DOCOSANOL	1 in 1 CARTON	CREAM	1	1
0713-0353-62	DOCOSANOL	2 g in 1 BOTTLE, PUMP	CREAM	2	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0353-02	GM - Gram	0713-0353	097b2fc1-e3d5-42b1-9696-1020c932e3be	1	2024-04-05
0713-0353-62	GM - Gram	0713-0353	1b278199-be99-4d22-8cbc-f1d3b1adb714	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0353	DOCOSANOL CREAM [COSETTE PHARMACEUTICALS, INC.]	1	Current NDC, 4 package rows	20240105_ccbb5e6d-cb85-449c-a480-28225d744f4d.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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCOSANOL	DOCOSANOL	CVS Pharmacy, Inc.	336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b	2026-03-13	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839
Docosanol	DOCOSANOL	Leader/ Cardinal Health 110, Inc.	ed18ecb7-70ce-4037-a738-6b159e364d62	2025-12-25	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839
Docosanol	DOCOSANOL	Alembic Pharmaceuticals Limited	a87a077d-9b0e-490d-b4ac-26c7045828db	2025-05-08	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839
DOCOSANOL	DOCOSANOL	Rugby Laboratories	6f8d6375-8188-42e9-a048-e8a554122ff3	2024-05-23	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839
DOCOSANOL	DOCOSANOL	Cosette Pharmaceuticals, Inc.	ccbb5e6d-cb85-449c-a480-28225d744f4d	2024-01-04	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839 ndc (product): 0713-0353
Docosanol	DOCOSANOL	Alembic Pharmaceuticals Inc.	86450000-1810-4739-9801-59beb7c19e67	2023-12-22	Warnings	Exact identifier application applno (ANDA): 215839 application number: ANDA215839

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	ccbb5e6d-cb85-449c-a480-28225d744f4d	1
797534	docosanol 100 MG/ML Topical Cream	SCD	ccbb5e6d-cb85-449c-a480-28225d744f4d	1
797534	docosanol 10 % Topical Cream	SY	ccbb5e6d-cb85-449c-a480-28225d744f4d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0713-0353-02	00713035302	1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE	1 tube	2024-01-04	No	No	Current
0713-0353-62	00713035362	1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP		2024-01-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Docosanol Cream, 10%	Cosette Pharmaceuticals, Inc. \| Alembic Pharmaceuticals Limited	2024-01-04	HUMAN OTC DRUG LABEL	1