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 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
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
2026-02-19 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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