ADAPALENE and BENZOYL PEROXIDE gel, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2025-06-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 21:35:24

Label at a glance#

ProductAdapalene and benzoyl peroxide

Active ingredientADAPALENE, BENZOYL PEROXIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Adapalene and benzoyl peroxide gel, USP 0.3%/2.5%

NDC 70771-1716-4

45 g

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1663745	adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel	PSN	3
1663745	adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel	SCD	3
1663745	adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ADAPALENE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
91d0a1ed-5d14-5017-c7aa-3602ee038695	Product name	3	20210111
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810
5c3dfd42-8936-4261-a420-cfcbbf3030aa	Product name	2	20161206
08f39758-2d46-8afe-73ca-39fe69052a2b	Product name	1	20140508
8ae7bcde-1dd2-b073-852b-f464987f7427	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70771-1716-3	Adapalene and benzoyl peroxide	1 in 1 BOTTLE, PUMP	GEL	1	3
70771-1716-3	Adapalene and benzoyl peroxide	60 g in 1 BOTTLE, PUMP	GEL	60	3
70771-1716-4	Adapalene and benzoyl peroxide	1 in 1 BOTTLE, PUMP	GEL	1	3
70771-1716-4	Adapalene and benzoyl peroxide	45 g in 1 BOTTLE, PUMP	GEL	45	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Adapalene and benzoyl peroxide
ADAPALENE
BENZOYL PEROXIDE
1-PROPANESULFONIC ACID, 2-METHYL-2-((1-OXO-2-PROPEN-1-YL)AMINO)-, SODIUM SALT (1:1), POLYMER WITH 2-PROPENAMIDE
DOCUSATE SODIUM
EDETATE DISODIUM
GLYCERIN
ISOHEXADECANE
POLOXAMER 124
POLYSORBATE 80
PROPYLENE GLYCOL
SORBITAN MONOOLEATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1716	70771-1716-4, 70771-1716-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ADAPALENE	1L4806J2QF	ACTIB
BENZOYL PEROXIDE	W9WZN9A0GM	ACTIB
1-PROPANESULFONIC ACID, 2-METHYL-2-((1-OXO-2-PROPEN-1-YL)AMINO)-, SODIUM SALT (1:1), POLYMER WITH 2-PROPENAMIDE	5F4963KLHS	IACT
DOCUSATE SODIUM	F05Q2T2JA0	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOHEXADECANE	918X1OUF1E	IACT
POLOXAMER 124	1S66E28KXA	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITAN MONOOLEATE	06XEA2VD56	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A214553-001	ADAPALENE AND BENZOYL PEROXIDE	ADAPALENE; BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB		2022-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A214553-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214553-001	ADAPALENE AND BENZOYL PEROXIDE	0.3%;2.5%	GEL / TOPICAL	AB	2022-06-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A214553-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A214553-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214553-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214553-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214553-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214553-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214553-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214553-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214553-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214553-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214553-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214553-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214553-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214553-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214553-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214553-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214553-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214553-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214553-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214553-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214553-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214553-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214553-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214553-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214553-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214553-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214553-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214553-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214553-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214553-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214553-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214553-001	AB	1	`a50c72e98297…`

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
Adapalene and benzoyl peroxide	ADAPALENE AND BENZOYL PEROXIDE	Zydus Lifesciences Limited	d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5	2025-06-13		Exact identifier ndc (package): 70771-1716-3 ndc (package): 70771-1716-4 ndc (product): 70771-1716 ndc11 (package): 70771171603 ndc11 (package): 70771171604 spl id: 2825a88e-4c88-4703-9128-ad478f3aae28 spl set id: d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5

Reported adverse events (FAERS/openFDA)#

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