DOCOSANOL

Product NDC: 46122-800
11-digit product format: 461220800
Labeler code: 46122
Product ID: 46122-800_d6559957-0082-42b1-a43d-7c92cbd8b1a8
Type: HUMAN OTC DRUG
Nonproprietary name: DOCOSANOL
Dosage form: CREAM
Route: TOPICAL
Labeler: Amerisource Bergen
Application: ANDA217090
Marketing category: ANDA
Marketing start: 2024-10-01
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
A217090-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2024-03-01

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	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`6a51e52b5d6a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217090-001	DOCOSANOL	10%	CREAM / TOPICAL	2024-03-01	`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
d6559957-0082-42b1-a43d-7c92cbd8b1a8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-800-36	DOCOSANOL	2 g in 1 TUBE	CREAM	2		1
46122-800-36	DOCOSANOL	1 in 1 PACKAGE	CREAM	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-800-36	GM - Gram	46122-800	987198da-f685-4da4-8bc3-30376280d0ce	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-800	DOCOSANOL CREAM [AMERISOURCE BERGEN]	1	Current NDC, 2 package rows	20241009_d6559957-0082-42b1-a43d-7c92cbd8b1a8.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	Aurohealth LLC	9f361f24-a0a1-4e43-a158-8c830c9adca7	2026-06-10	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090
AMAZON BASICS DOCOSANOL	DOCOSANOL	Amazon.com Services LLC	3c28a462-c6d6-70ba-e063-6394a90ae8f3	2026-03-18	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090
DOCOSANOL	DOCOSANOL	KROGER COMPANY	16ae0976-2940-27ae-e063-6394a90a62e8	2025-12-11	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090
Cold Sore Treatment Docosanol	DOCOSANOL	Blistex Inc.	bcdd51a9-210c-4d92-b67e-e3ac16c99812	2025-04-11	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090
DOCOSANOL	DOCOSANOL	Amerisource Bergen	d6559957-0082-42b1-a43d-7c92cbd8b1a8	2024-10-01	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090 ndc (product): 46122-800
Julie Cold Sore Treatment	DOCOSANOL	Julie Products Inc	113372a4-58de-f829-e063-6294a90a4eb1	2024-07-19	Warnings	Exact identifier application applno (ANDA): 217090 application number: ANDA217090

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	d6559957-0082-42b1-a43d-7c92cbd8b1a8	1
797534	docosanol 100 MG/ML Topical Cream	SCD	d6559957-0082-42b1-a43d-7c92cbd8b1a8	1
797534	docosanol 10 % Topical Cream	SY	d6559957-0082-42b1-a43d-7c92cbd8b1a8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46122-800-36	46122080036	1 TUBE in 1 PACKAGE (46122-800-36) / 2 g in 1 TUBE	1 tube	2024-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOCOSANOL - Amerisource Bergen \| Aurohealth LLC \| APL HEALTHCARE LIMITED	Amerisource Bergen \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2024-10-01	Human OTC Drug Label	1