Home NDC 72578-119 Adapalene and benzoyl peroxide
Product NDC 72578-119
11-digit product format 725780119
Labeler code 72578
Product ID 72578-119_edefb257-b872-45cb-a882-fa6991d6cb57
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Adapalene and benzoyl peroxide
Dosage form GEL
Route TOPICAL
Labeler Viona Pharmaceuticals Inc
Application ANDA214553
Marketing category ANDA
Marketing start 2022-06-06
Substance ADAPALENE; BENZOYL PEROXIDE
Active strength 3; 25 mg/g; mg/g
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
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 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 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 RLD / RS Approval date Source SHA-256 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# Additional Listing Data#
Finished product Yes
Brand name base Adapalene and benzoyl peroxide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ADAPALENE 3 mg/g BENZOYL PEROXIDE 25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1L4806J2QF Internal UNII lookup W9WZN9A0GM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1663745 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72578-119-02 Adapalene and benzoyl peroxide 60 g in 1 BOTTLE, PUMP GEL 60 3 72578-119-02 Adapalene and benzoyl peroxide 1 in 1 BOTTLE, PUMP GEL 1 3 72578-119-04 Adapalene and benzoyl peroxide 1 in 1 BOTTLE, PUMP GEL 1 3 72578-119-04 Adapalene and benzoyl peroxide 45 g in 1 BOTTLE, PUMP GEL 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72578-119 ADAPALENE AND BENZOYL PEROXIDE GEL [VIONA PHARMACEUTICALS INC] 2 Current NDC, Legacy NDC, 4 package rows 20221007_3a0fa489-4720-4760-a476-2317aef5a231.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72578-119-02 72578011902 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-02) / 60 g in 1 BOTTLE, PUMP 2022-06-06 0000-00-00 No No Current 72578-119-04 72578011904 1 BOTTLE, PUMP in 1 BOTTLE, PUMP (72578-119-04) / 45 g in 1 BOTTLE, PUMP 2022-06-06 0000-00-00 No No Current