adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel
- RxCUI
- 1663745
- RxNorm name
- adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel
- Display name
- Adapalene/Benzoyl peroxide (Topical)
- Full name
- adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel
- Term type
- SCD
- Status
- Active
- Strength
- 0.3-2.5%
- Dose form
- Gel
- Route
- Topical
- Updated
- 2026-10-20 20:50:17
RxNorm Status History#
- Status
- Active
- Source
- RXNORM
- Current
- YES
- Release start
- 092015
- Active start
- 092015
- Multiple ingredient
- YES
- Branded
- NO
Ingredients And Strength#
| Ingredient | Strength | Base | Basis of strength |
|---|---|---|---|
| benzoyl peroxide | 0.025 MG / 1 MG | benzoyl peroxide | benzoyl peroxide |
| adapalene | 0.003 MG / 1 MG | adapalene | adapalene |
Dose Form Concepts#
| Dose form | RxCUI |
|---|---|
| Topical Gel | 346286 |
Derived Ingredient Concepts#
| Ingredient | RxCUI |
|---|---|
| benzoyl peroxide | 1418 |
| adapalene | 60223 |
Source Vocabulary Codes#
| Code type | Values | Count | Category |
|---|---|---|---|
| PRESCRIBABLE | Y | 1 | ATTRIBUTES |
| RXNAV_STR | adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel | 1 | NAMES |
| RxNorm Name | adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel | 1 | NAMES |
| RxNorm Synonym | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel | 1 | NAMES |
| TTY | SCD | 1 | ATTRIBUTES |
| SPL_SET_ID | 11 linked values
| 11 | CODES |
| RxCUI | 1663745 | 1 | CODES |
| MMSL_CODE | 2 | CODES |
FDA NDC Products And Packages#
| Package NDC | Product NDC | Name | Labeler | Application |
|---|---|---|---|---|
| 0480-3154-45 | 0480-3154 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Teva Pharmaceuticals, Inc. | ANDA209641 |
| 45802-853-45 | 45802-853 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide | Padagis Israel Pharmaceuticals Ltd | ANDA212464 |
| 46708-662-45 | 46708-662 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide topical | Alembic Pharmaceuticals Limited | ANDA214185 |
| 51672-1384-4 | 51672-1384 | Adapalene and Benzoyl Peroxide ADAPALENE and BENZOYL PEROXIDE | Sun Pharmaceutical Industries, Inc. | ANDA209148 |
| 51672-1384-9 | 51672-1384 | Adapalene and Benzoyl Peroxide ADAPALENE and BENZOYL PEROXIDE | Sun Pharmaceutical Industries, Inc. | ANDA209148 |
| 59651-604-46 | 59651-604 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Aurobindo Pharma Limited | ANDA217384 |
| 59651-604-60 | 59651-604 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Aurobindo Pharma Limited | ANDA217384 |
| 62332-662-45 | 62332-662 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide topical | Alembic Pharmaceuticals Inc. | ANDA214185 |
| 63629-9322-1 | 63629-9322 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide | Bryant Ranch Prepack | ANDA212464 |
| 68308-662-45 | 68308-662 | adapalene and benzoyl peroxide adapalene and benzoyl peroxide | Mayne Pharma Inc. | NDA207917 |
| 70771-1716-3 | 70771-1716 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Zydus Lifesciences Limited | ANDA214553 |
| 70771-1716-4 | 70771-1716 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Zydus Lifesciences Limited | ANDA214553 |
| 72162-1432-2 | 72162-1432 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide | Bryant Ranch Prepack | ANDA212464 |
| 72578-119-02 | 72578-119 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Viona Pharmaceuticals Inc | ANDA214553 |
| 72578-119-04 | 72578-119 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | Viona Pharmaceuticals Inc | ANDA214553 |
Drugs@FDA Applications#
| Application | NDC | Name | Marketing category | Labeler |
|---|---|---|---|---|
| ANDA209641 | 0480-3154 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | ANDA | Teva Pharmaceuticals, Inc. |
| ANDA212464 | 45802-853 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide | ANDA | Padagis Israel Pharmaceuticals Ltd |
| ANDA214185 | 46708-662 | ADAPALENE AND BENZOYL PEROXIDE adapalene and benzoyl peroxide topical | ANDA | Alembic Pharmaceuticals Limited |
| ANDA209148 | 51672-1384 | Adapalene and Benzoyl Peroxide ADAPALENE and BENZOYL PEROXIDE | ANDA | Sun Pharmaceutical Industries, Inc. |
| ANDA217384 | 59651-604 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | ANDA | Aurobindo Pharma Limited |
| NDA207917 | 68308-662 | adapalene and benzoyl peroxide adapalene and benzoyl peroxide | NDA AUTHORIZED GENERIC | Mayne Pharma Inc. |
| ANDA214553 | 70771-1716 | Adapalene and benzoyl peroxide Adapalene and benzoyl peroxide | ANDA | Zydus Lifesciences Limited |
UNII Substances#
No records found.
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed RxNorm Mappings#
| Set ID | RxNorm mappings | Terms | SPL version | Label | Effective |
|---|---|---|---|---|---|
| 91161d2f-8990-4268-bd74-f60cf33aa2a1 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 101 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | 20240115 |
| ceae42d9-0264-4a52-a17a-af68b2538ff9 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 100 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | 20240313 |
| 73a32997-23da-46b6-8652-7197f55c9847 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 9 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | 20250521 |
| f4e5d381-098a-4c93-9ff0-002cae46daac | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 8 | These highlights do not include all the information needed to use EPIDUO FORTE safely and effectively. See full prescribing information for EPIDUO FORTE. EPIDUO ® FORTE (adapalene and benzoyl peroxide) topical gel. Initial U.S. Approval: 2015 | 20241024 |
| 13fc72e9-7178-4a8b-9fe8-d88ba591dac8 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 7 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | 20250702 |
| 56541736-c70e-4fcd-9614-6cfdc5044136 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 4 | These highlights do not include all the information needed to use Adapalene and Benzoyl Peroxide gel safely and effectively. See full prescribing information for Adapalene and Benzoyl Peroxide gel. Adapalene and Benzoyl Peroxide topical gel 0.3%/2.5% Initial U.S. Approval: 2015 | 20220831 |
| 3a0fa489-4720-4760-a476-2317aef5a231 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 3 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE GEL. ADAPALENE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2015 | 20250613 |
| d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 3 | ADAPALENE and BENZOYL PEROXIDE gel, USP | 20250613 |
| 05babd5f-18ab-4646-8962-cb000ed0f9a8 | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 2 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL . ADAPALENE and BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | 20220501 |
| 2d4e5111-4f9f-42dd-8cf7-56bdc51fbbad | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 1 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | 20250527 |
| 92dcba02-f42f-482d-8cd5-2b5ab8fa540a | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [PSN] · adapalene 0.003 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [SCD] · adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel [SY] | 3 | 1 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | 20220602 |
Recently Linked DailyMed Labels#
| Set ID | Title | Manufacturer | Effective |
|---|---|---|---|
| 25e4ee12-f43a-4c87-9e34-64e91d06a368 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE GEL. ADAPALENE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2015 | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 20260723 |
| 13fc72e9-7178-4a8b-9fe8-d88ba591dac8 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | 20250702 |
| 3a0fa489-4720-4760-a476-2317aef5a231 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE GEL. ADAPALENE and BENZOYL PEROXIDE gel, for topical use Initial U.S. Approval: 2015 | Viona Pharmaceuticals Inc | Zydus Lifesciences Limited | 20250613 |
| d374a9b9-3ee9-4bc4-bcb9-a947d76cb6e5 | ADAPALENE and BENZOYL PEROXIDE gel, USP | Zydus Lifesciences Limited | 20250613 |
| 2d4e5111-4f9f-42dd-8cf7-56bdc51fbbad | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | Alembic Pharmaceuticals Limited | 20250527 |
| 73a32997-23da-46b6-8652-7197f55c9847 | These highlights do not include all the information needed to use ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE AND BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE AND BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | Alembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited | 20250521 |
| ceae42d9-0264-4a52-a17a-af68b2538ff9 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | Bryant Ranch Prepack | 20240313 |
| 91161d2f-8990-4268-bd74-f60cf33aa2a1 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | Bryant Ranch Prepack | 20240115 |
| 0baf6f07-2420-45c9-8ddd-53d5c292dd04 | These highlights do not include all the information needed to use Adapalene and Benzoyl Peroxide gel safely and effectively. See full prescribing information for Adapalene and Benzoyl Peroxide gel. Adapalene and Benzoyl Peroxide gel, 0.3%/2.5% is for topical use. Initial U.S. Approval: 2015 | TEVA PHARMACEUTICALS USA, INC | G Production Inc. | 20221128 |
| 56541736-c70e-4fcd-9614-6cfdc5044136 | These highlights do not include all the information needed to use Adapalene and Benzoyl Peroxide gel safely and effectively. See full prescribing information for Adapalene and Benzoyl Peroxide gel. Adapalene and Benzoyl Peroxide topical gel 0.3%/2.5% Initial U.S. Approval: 2015 | Mayne Pharma Inc. | G Production Inc. | 20220831 |
| 92dcba02-f42f-482d-8cd5-2b5ab8fa540a | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL. ADAPALENE and BENZOYL PEROXIDE topical gel, 0.3%/2.5% Initial U.S. Approval: 2015 | Padagis Israel Pharmaceuticals Ltd | 20220602 |
| 05babd5f-18ab-4646-8962-cb000ed0f9a8 | These highlights do not include all the information needed to use ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL safely and effectively. See full prescribing information for ADAPALENE and BENZOYL PEROXIDE TOPICAL GEL . ADAPALENE and BENZOYL PEROXIDE topical gel Initial U.S. Approval: 2015 | Teva Pharmaceuticals, Inc. | 20220501 |
Drug Classes#
| Source | Class ID | Class | Type | Relationship | Drug concept |
|---|---|---|---|---|---|
| ATC | D10AE | Peroxides | ATC1-4 | benzoyl peroxide | |
| ATC | D10AD | Retinoids for topical use in acne | ATC1-4 | adapalene | |
| FDASPL | D012176 | Retinoids | CHEM | has_chemical_structure | adapalene |
| FDASPL | N0000175607 | Retinoid | EPC | has_epc | adapalene |
| MEDRT | D000068816 | Adapalene | CHEM | has_ingredient | adapalene |
| MEDRT | D001585 | Benzoyl Peroxide | CHEM | has_ingredient | benzoyl peroxide |
| MEDRT | D000152 | Acne Vulgaris | DISEASE | may_treat | adapalene |
| MEDRT | D000152 | Acne Vulgaris | DISEASE | may_treat | benzoyl peroxide |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | adapalene |
| MEDRT | D004342 | Drug Hypersensitivity | DISEASE | ci_with | benzoyl peroxide |
| MEDRT | D012393 | Rosacea | DISEASE | may_treat | benzoyl peroxide |
| MEDRT | N0000000170 | Free Radical Scavenging Activity | MOA | has_moa | benzoyl peroxide |
| MEDRT | N0000000242 | Transcription Factor Activity | MOA | has_moa | adapalene |
| MEDRT | N0000008342 | Cellular Division Phase Alteration | PE | has_pe | adapalene |
| MEDRT | N0000008344 | Cellular Growth Phase Arrest | PE | has_pe | adapalene |
| MEDRT | N0000175676 | Decreased Epithelial Proliferation | PE | has_pe | adapalene |
| MEDRT | N0000008663 | Decreased Immunologically Active Molecule Activity | PE | has_pe | adapalene |
| MEDRT | N0000009982 | Decreased Sebaceous Gland Activity | PE | has_pe | benzoyl peroxide |
| MEDRT | N0000009982 | Decreased Sebaceous Gland Activity | PE | has_pe | adapalene |
| MEDRT | N0000009973 | Keratin Alteration | PE | has_pe | adapalene |
Properties#
| Category | Property | Value |
|---|---|---|
| ATTRIBUTES | AVAILABLE_STRENGTH | 0.003 MG/MG / 0.025 MG/MG |
| ATTRIBUTES | GENERAL_CARDINALITY | MULTI |
| ATTRIBUTES | HUMAN_DRUG | US |
| ATTRIBUTES | RXNAV_HUMAN_DRUG | US |
| ATTRIBUTES | SCHEDULE | 0 |
| CODES | ANDA | ANDA209148 |
| CODES | ANDA | ANDA209641 |
| CODES | ANDA | ANDA212464 |
| CODES | ANDA | ANDA214185 |
| CODES | ANDA | ANDA214553 |
| CODES | ANDA | ANDA217384 |
| CODES | VUID | 4034677 |
| NAMES | Prescribable Synonym | adapalene 0.3 % / benzoyl peroxide 2.5 % Topical Gel |
| SOURCES | Source | Gold Standard Alchemy |
| SOURCES | Source | Metathesaurus FDA Structured Product Labels |
| SOURCES | Source | Micromedex RED BOOK |
| SOURCES | Source | Multum MediSource Lexicon |
| SOURCES | Source | National Drug Data File Plus Source Vocabulary |
| SOURCES | Source | Veterans Health Administration National Drug File |