Cold Sore Fever Blister Treatment

Product NDC: 81522-112
11-digit product format: 815220112
Labeler code: 81522
Product ID: 81522-112_788e64c2-c330-4488-aa87-35fdd7fed014
Type: HUMAN OTC DRUG
Nonproprietary name: Docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: FSA Store Inc. (Caring Mills)
Application: ANDA212385
Marketing category: ANDA
Marketing start: 2023-12-31
Marketing end: 2027-08-28
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212385-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2022-10-07

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
2026-09-14 22:38:34	2026-08	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212385-001	DOCOSANOL	10%	CREAM / TOPICAL	2022-10-07	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Cold Sore Fever Blister Treatment

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
fe67f56e-4c35-40cb-8a75-174a873f2900	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81522-112-07	Cold Sore Fever Blister Treatment	2 g in 1 TUBE	CREAM	2		4
81522-112-07	Cold Sore Fever Blister Treatment	1 in 1 PACKAGE	CREAM	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-112	COLD SORE FEVER BLISTER TREATMENT (DOCOSANOL) CREAM [FSA STORE INC. (CARING MILLS)]	3	Current NDC, 2 package rows	20240127_fe67f56e-4c35-40cb-8a75-174a873f2900.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 2 of 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOCOSANOL	DOCOSANOL	H2-Pharma, LLC	48c029bd-c061-4228-b66f-a70a297185b7	2023-07-20	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Meijer Distribution Inc.	f00f46a0-2746-4538-93b6-09930d9c110c	2023-07-19	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	H E B	98726ef3-ae48-4447-86de-17d37d2324cd	2023-07-19	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385
Cold Sore Fever Blister Treatment	DOCOSANOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	edeae56f-6061-45a7-a79d-845a60306799	2023-07-07	Warnings	Exact identifier application applno (ANDA): 212385 application number: ANDA212385

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	fe67f56e-4c35-40cb-8a75-174a873f2900	4
797534	docosanol 100 MG/ML Topical Cream	SCD	fe67f56e-4c35-40cb-8a75-174a873f2900	4
797534	docosanol 10 % Topical Cream	SY	fe67f56e-4c35-40cb-8a75-174a873f2900	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81522-112-07	81522011207	1 TUBE in 1 PACKAGE (81522-112-07) / 2 g in 1 TUBE	1 tube	2023-12-31	2027-08-28	No	No	Historical