Cold Sore Treatment Docosanol

Product NDC: 10157-2124
11-digit product format: 101572124
Labeler code: 10157
Product ID: 10157-2124_75847eb8-3765-4c32-8c4c-f39b22d3aab3
Type: HUMAN OTC DRUG
Nonproprietary name: DOCOSANOL
Dosage form: CREAM
Route: TOPICAL
Labeler: Blistex Inc.
Application: ANDA217090
Marketing category: ANDA
Marketing start: 2025-05-01
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: Cold Sore Treatment 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
bcdd51a9-210c-4d92-b67e-e3ac16c99812	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10157-2124-2	Cold Sore Treatment Docosanol	1 in 1 BLISTER PACK	CREAM	1		1
10157-2124-2	Cold Sore Treatment Docosanol	2 g in 1 TUBE	CREAM	2		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10157-2124	COLD SORE TREATMENT DOCOSANOL (DOCOSANOL) CREAM [BLISTEX INC.]	1	Current NDC, 2 package rows	20250501_bcdd51a9-210c-4d92-b67e-e3ac16c99812.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 ndc (product): 10157-2124
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

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	bcdd51a9-210c-4d92-b67e-e3ac16c99812	1
797534	docosanol 100 MG/ML Topical Cream	SCD	bcdd51a9-210c-4d92-b67e-e3ac16c99812	1
797534	docosanol 10 % Topical Cream	SY	bcdd51a9-210c-4d92-b67e-e3ac16c99812	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
10157-2124-2	10157212402	1 TUBE in 1 BLISTER PACK (10157-2124-2) / 2 g in 1 TUBE	1 tube	2025-05-01	No	No	Current