AMAZON BASICS DOCOSANOL

Product NDC: 72288-006
11-digit product format: 722880006
Labeler code: 72288
Product ID: 72288-006_479ae2d4-63cb-4e54-b0fc-b0754b7929c1
Type: HUMAN OTC DRUG
Nonproprietary name: DOCOSANOL
Dosage form: CREAM
Route: TOPICAL
Labeler: Amazon.com Services LLC
Application: ANDA217090
Marketing category: ANDA
Marketing start: 2026-03-17
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
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…`

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	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 ndc (product): 72288-006
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: AMAZON BASICS DOCOSANOL
Listing expiration: 2027-12-31

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
3c28a462-c6d6-70ba-e063-6394a90ae8f3	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
72288-006-01	AMAZON BASICS DOCOSANOL	2 g in 1 TUBE	CREAM	2		3
72288-006-01	AMAZON BASICS DOCOSANOL	1 in 1 PACKAGE	CREAM	1		3

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	3c28a462-c6d6-70ba-e063-6394a90ae8f3	3
797534	docosanol 100 MG/ML Topical Cream	SCD	3c28a462-c6d6-70ba-e063-6394a90ae8f3	3
797534	docosanol 10 % Topical Cream	SY	3c28a462-c6d6-70ba-e063-6394a90ae8f3	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72288-006-01	72288000601	1 TUBE in 1 PACKAGE (72288-006-01) / 2 g in 1 TUBE	1 tube	2026-03-17	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOCOSANOL - Amazon.com Services LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED	Amazon.com Services LLC \| Aurohealth LLC \| APL HEALTHCARE LIMITED	2026-03-18	Human OTC Drug Label	3