ABREVA

Product NDC: 0135-0200
Requested package NDC: 0135-0200-03
11-digit product format: 001350200
Labeler code: 0135
Product ID: 0135-0200_1b525ee7-41df-5a73-e063-6294a90a0b86
Type: HUMAN OTC DRUG
Nonproprietary name: docosanol
Dosage form: CREAM
Route: TOPICAL
Labeler: Haleon US Holdings LLC
Application: NDA020941
Marketing category: NDA
Marketing start: 2010-03-19
Substance: DOCOSANOL
Active strength: 100 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0135-0200	0135-0200-03	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
N020941-001	ABREVA	DOCOSANOL	10%	CREAM / TOPICAL		RLD, RS	2000-07-25

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`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
c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0135-0200-01	2020-10-06	Drug Facts
0135-0200-03	2020-10-06	Drug Facts
0135-0200-04	2020-10-06	Drug Facts
0135-0200-05	2020-10-06	Drug Facts
0135-0200-01	2020-01-31	Drug Facts
0135-0200-03	2020-01-31	Drug Facts
0135-0200-04	2020-01-31	Drug Facts
0135-0200-05	2020-01-31	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0135-0200-01	ABREVA	2 g in 1 TUBE	CREAM	2	16
0135-0200-03	ABREVA	2 g in 1 BOTTLE, PUMP	CREAM	2	16
0135-0200-04	ABREVA	2 g in 1 TUBE	CREAM	2	16
0135-0200-04	ABREVA	2 in 1 PACKAGE	CREAM	2	16
0135-0200-05	ABREVA	2 g in 1 TUBE	CREAM	2	16
0135-0200-05	ABREVA	2 in 1 PACKAGE	CREAM	2	16
0135-0200-06	ABREVA	2 g in 1 BOTTLE, PUMP	CREAM	2	16
0135-0200-06	ABREVA	3 in 1 PACKAGE	CREAM	3	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0200-01	GM - Gram	0135-0200	3ef7e703-fc30-449e-a5cd-21670dfd305d	1	2012-07-24
0135-0200-03	GM - Gram	0135-0200	c31659c2-e299-40ca-a41a-5ac16e279481	1	2012-07-24
0135-0200-05	GM - Gram	0135-0200	70ef30a4-324f-46d2-8b07-d75741ffaa75	1	2017-07-07
0135-0200-06	GM - Gram	0135-0200	623cfb8d-fa47-471d-a8b5-b07e48c439ab	1	2025-02-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCOSANOL	ACTIVE INGREDIENT	9G1OE216XY	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
DOCOSANOL	ACTIVE MOIETY	9G1OE216XY	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SUCROSE DISTEARATE	INACTIVE INGREDIENT	33X4X4B90S	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
SUCROSE STEARATE	INACTIVE INGREDIENT	274KW0O50M	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	ABREVA (DOCOSANOL) CREAM [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0200	ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC]	16	Current NDC, Legacy NDC, 8 package rows	20240621_c39b38a7-dcdd-4c32-8f35-b565c4d3cec6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABREVA	DOCOSANOL	Haleon US Holdings LLC	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	2024-06-20	Warnings	Exact identifier application applno (NDA): 020941 application number: NDA020941 ndc (package): 0135-0200-03 ndc (product): 0135-0200 ndc11 (package): 00135020003

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	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
797534	docosanol 10 % Topical Cream	PSN	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
855205	docosanol 100 MG/ML Topical Cream [Abreva]	SBD	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
797534	docosanol 100 MG/ML Topical Cream	SCD	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
855205	Abreva 10 % Topical Cream	SY	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
797534	docosanol 10 % Topical Cream	SY	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	16
855205	Abreva 10 % Topical Cream	PSN	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5
797534	docosanol 10 % Topical Cream	PSN	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5
855205	docosanol 100 MG/ML Topical Cream [Abreva]	SBD	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5
797534	docosanol 100 MG/ML Topical Cream	SCD	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5
855205	Abreva 10 % Topical Cream	SY	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5
797534	docosanol 10 % Topical Cream	SY	8b292cc5-c9ec-44ab-8c08-ba153a58d9fd	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0200-03	00135020003	2 g in 1 BOTTLE, PUMP (0135-0200-03)	2 g	2010-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2024-06-20	HUMAN OTC DRUG LABEL	16
Drug Facts	A-S Medication Solutions	2021-04-16	HUMAN OTC DRUG LABEL	5