epiduo forte
- Product NDC
- 0299-5906
- 11-digit product format
- 002995906
- Labeler code
- 0299
- Product ID
- 0299-5906_253bb988-14bf-4654-e063-6394a90a0fe0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- adapalene and benzoyl peroxide
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Galderma Laboratories, L.P.
- Application
- NDA207917
- Marketing category
- NDA
- Marketing start
- 2015-07-01
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- epiduo forte
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ADAPALENE | 3 mg/g |
| BENZOYL PEROXIDE | 25 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 1L4806J2QF, W9WZN9A0GM |
| Rxcui | 1663745, 1663747 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ADAPALENE | ACTIVE INGREDIENT | 1L4806J2QF | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| BENZOYL PEROXIDE | ACTIVE INGREDIENT | W9WZN9A0GM | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| ADAPALENE | ACTIVE MOIETY | 1L4806J2QF | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| BENZOYL PEROXIDE | ACTIVE MOIETY | W9WZN9A0GM | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) | INACTIVE INGREDIENT | M4PPW69Y4H | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| POLOXAMER 124 | INACTIVE INGREDIENT | 1S66E28KXA | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| SORBITAN MONOOLEATE | INACTIVE INGREDIENT | 06XEA2VD56 | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0299-5906 | EPIDUO FORTE (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.] | 8 | Current NDC, Legacy NDC, 15 package rows | 20241027_f4e5d381-098a-4c93-9ff0-002cae46daac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0299-5906-00 | 00299590600 | 2 g in 1 TUBE (0299-5906-00) | 2 g | 2019-11-01 | 0000-00-00 | Yes | No | Current |
| 0299-5906-02 | 00299590602 | 1 TUBE in 1 BLISTER PACK (0299-5906-02) / 2 g in 1 TUBE | 1 tube | 2015-07-01 | 0000-00-00 | Yes | No | Current |
| 0299-5906-05 | 00299590605 | 1 TUBE in 1 BLISTER PACK (0299-5906-05) / 5 g in 1 TUBE | 1 tube | 2015-07-01 | 0000-00-00 | Yes | No | Current |
| 0299-5906-15 | 00299590615 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-15) / 15 g in 1 BOTTLE, PUMP | | 2015-07-01 | 0000-00-00 | No | No | Current |
| 0299-5906-30 | 00299590630 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-30) / 30 g in 1 BOTTLE, PUMP | | 2015-07-01 | 0000-00-00 | No | No | Current |
| 0299-5906-45 | 00299590645 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-45) / 45 g in 1 BOTTLE, PUMP | | 2015-07-01 | 0000-00-00 | No | No | Current |
| 0299-5906-60 | 00299590660 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-60) / 60 g in 1 BOTTLE, PUMP | | 2015-07-01 | 0000-00-00 | No | No | Current |
| 0299-5906-70 | 00299590670 | 1 BOTTLE, PUMP in 1 CARTON (0299-5906-70) / 70 g in 1 BOTTLE, PUMP | | 2015-07-01 | 0000-00-00 | No | No | Current |