ABREVA

Product NDC: 0135-0300
11-digit product format: 001350300
Labeler code: 0135
Product ID: 0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8
Type: HUMAN OTC DRUG
Nonproprietary name: docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: Haleon US Holdings LLC
Application: ANDA208754
Marketing category: ANDA
Marketing start: 2022-03-25
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
A208754-001	DOCOSANOL	DOCOSANOL	10%	CREAM / TOPICAL			2018-11-19

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.

Product history page 1 of 2 · 41 observed 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	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208754-001	DOCOSANOL	10%	CREAM / TOPICAL	2018-11-19	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ABREVA
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
797534	Internal RxNorm lookup
855205	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
bf02c8c5-af60-41f1-a202-38a97491a720	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0300-01	ABREVA	2 g in 1 TUBE	CREAM	2	5
0135-0300-01	ABREVA	1 in 1 PACKAGE	CREAM	1	5
0135-0300-02	ABREVA	2 in 1 PACKAGE	CREAM	2	5
0135-0300-02	ABREVA	2 g in 1 TUBE	CREAM	2	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0300-01	GM - Gram	0135-0300	1968a6b0-e0d0-44c0-bab1-5eaf4faa11f8	1	2023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0300	ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC, 4 package rows	20240621_bf02c8c5-af60-41f1-a202-38a97491a720.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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	ac3280b7-00aa-46cd-84e2-0a11992028ab	2026-07-09	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	The Kroger Co.	42b46e02-4d1f-411e-be9e-227f62ba5a86	2026-06-23	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	WALMART INC. (see also Equate)	f283ffd8-860a-4e97-8e22-94b907f75c8d	2026-04-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	P & L Development, LLC	e88e49b9-c292-48c5-b19e-630ffa6447e7	2026-04-02	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	45cfa88b-8146-4349-99cc-beec70455709	2026-02-18	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	TARGET Corporation	f68bd51a-9166-47a1-81f7-e379a93ab823	2026-01-22	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	a578c749-4264-4d5c-9357-ed482a04fb8b	2026-01-15	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Walgreens	73178cbc-21f8-4fc1-8d31-50601f10dbd4	2025-12-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	e06fd4cf-cd92-4cae-94b7-abab95e97ebd	2025-12-29	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	United Natural Foods, Inc. dba UNFI	7dd527af-878c-4150-86d0-69881b5e3f8f	2025-11-17	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4286c19b-8c81-40f6-8d97-cfebba87c174	2025-10-10	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Family Dollar (FAMILY WELLNESS)	40297d6b-1096-467b-906c-701959884566	2025-10-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Topco Associates	65351744-0438-4416-ae1f-9169fc21d813	2025-09-11	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Strategic Sourcing Services LLC	3faf583c-90d2-4620-93ea-d763191ab452	2025-09-09	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	b62ee383-631a-4220-8dfd-48ec67bb0a63	2025-09-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	WALMART INC. (see also Equate)	cb2c7675-8045-4c38-8479-7d819d808664	2025-08-22	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	Best Choice (Valu Merchandisers Company)	ea458b65-8144-4671-857a-33b19c453e05	2025-08-21	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Chain Drug Consortium, LLC	86406372-9e95-43b9-b275-5661141a085b	2025-06-26	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Docosanol	DOCOSANOL	AAFES/Your Military Exchanges	b056ad46-bf48-4468-8b65-9e80176b6c52	2025-05-08	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754
Cold Sore Fever Blister Treatment	DOCOSANOL	Safeway, Inc.	5871e578-d16e-4f07-a32e-5263f9ca0a6a	2024-08-21	Warnings	Exact identifier application applno (ANDA): 208754 application number: ANDA208754

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
855205	Abreva 10 % Topical Cream	PSN	bf02c8c5-af60-41f1-a202-38a97491a720	5
797534	docosanol 10 % Topical Cream	PSN	bf02c8c5-af60-41f1-a202-38a97491a720	5
855205	docosanol 100 MG/ML Topical Cream [Abreva]	SBD	bf02c8c5-af60-41f1-a202-38a97491a720	5
797534	docosanol 100 MG/ML Topical Cream	SCD	bf02c8c5-af60-41f1-a202-38a97491a720	5
855205	Abreva 10 % Topical Cream	SY	bf02c8c5-af60-41f1-a202-38a97491a720	5
797534	docosanol 10 % Topical Cream	SY	bf02c8c5-af60-41f1-a202-38a97491a720	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0300-01	00135030001	1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE	1 tube	2022-03-25	0000-00-00	No	No	Current
0135-0300-02	00135030002	2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE	2 tube	2022-04-25	0000-00-00	No	No	Current