FDA.reportPublic FDA data

EPIDUO

Product NDC
0299-5908
11-digit product format
002995908
Labeler code
0299
Product ID
0299-5908_253bbb0c-966a-0d65-e063-6294a90a5f07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene and benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA022320
Marketing category
NDA
Marketing start
2008-12-08
Substance
ADAPALENE; BENZOYL PEROXIDE
Active strength
1; 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5908-00EPIDUO2 g in 1 TUBEGEL213
0299-5908-00EPIDUO1 in 1 BLISTER PACKGEL113
0299-5908-02EPIDUO2 g in 1 TUBEGEL213
0299-5908-25EPIDUO1 in 1 CARTONGEL113
0299-5908-25EPIDUO45 g in 1 BOTTLE, PUMPGEL4513
0299-5908-45EPIDUO45 g in 1 TUBEGEL4513
0299-5908-45EPIDUO1 in 1 CARTONGEL113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5908-25GM - Gram0299-59087a1bab7c-31c9-4436-9ff3-8be1d65f187f12012-07-24
0299-5908-45GM - Gram0299-59085ce91e78-f486-4e20-9b3e-68d39bf02c4712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ADAPALENEACTIVE INGREDIENT1L4806J2QFEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
ADAPALENEACTIVE MOIETY1L4806J2QFEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
edetate disodiumINACTIVE INGREDIENT7FLD91C86KEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
glycerinINACTIVE INGREDIENTPDC6A3C0OXEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
IsohexadecaneINACTIVE INGREDIENT918X1OUF1EEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
poloxamer 124INACTIVE INGREDIENT1S66E28KXAEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
propylene glycolINACTIVE INGREDIENT6DC9Q167V3EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
Sorbitan MonooleateINACTIVE INGREDIENT06XEA2VD56EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
WaterINACTIVE INGREDIENT059QF0KO0REPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]9
ADAPALENEACTIVE INGREDIENT1L4806J2QFEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
ADAPALENEACTIVE MOIETY1L4806J2QFEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
IsohexadecaneINACTIVE INGREDIENT918X1OUF1EEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
poloxamer 124INACTIVE INGREDIENT1S66E28KXAEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HEPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Sorbitan MonooleateINACTIVE INGREDIENT06XEA2VD56EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0REPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5908EPIDUO (ADAPALENE AND BENZOYL PEROXIDE) GEL [GALDERMA LABORATORIES, L.P.]13Current NDC, Legacy NDC, 7 package rows20241027_a0610f87-3b39-458a-afa3-66be1fefd1de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSNa0610f87-3b39-458a-afa3-66be1fefd1de13
830648Epiduo 0.1 % / 2.5 % Topical GelPSNa0610f87-3b39-458a-afa3-66be1fefd1de13
830648adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]SBDa0610f87-3b39-458a-afa3-66be1fefd1de13
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCDa0610f87-3b39-458a-afa3-66be1fefd1de13
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSYa0610f87-3b39-458a-afa3-66be1fefd1de13
830648Epiduo (adapalene 0.1 % / benzoyl peroxide 2.5 %) Topical GelSYa0610f87-3b39-458a-afa3-66be1fefd1de13
830648Epiduo (adapalene 1 MG / benzoyl peroxide 25 MG) per GM Topical GelSYa0610f87-3b39-458a-afa3-66be1fefd1de13
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelPSN67002593-3bd3-4e91-a48f-9f7483e579a02
830648Epiduo 0.1 % / 2.5 % Topical GelPSN67002593-3bd3-4e91-a48f-9f7483e579a02
830648adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical Gel [Epiduo]SBD67002593-3bd3-4e91-a48f-9f7483e579a02
829539adapalene 0.001 MG/MG / benzoyl peroxide 0.025 MG/MG Topical GelSCD67002593-3bd3-4e91-a48f-9f7483e579a02
829539adapalene 0.1 % / benzoyl peroxide 2.5 % Topical GelSY67002593-3bd3-4e91-a48f-9f7483e579a02
830648Epiduo (adapalene 0.1 % / benzoyl peroxide 2.5 %) Topical GelSY67002593-3bd3-4e91-a48f-9f7483e579a02
830648Epiduo (adapalene 1 MG / benzoyl peroxide 25 MG) per GM Topical GelSY67002593-3bd3-4e91-a48f-9f7483e579a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5908-00002995908001 TUBE in 1 BLISTER PACK (0299-5908-00) / 2 g in 1 TUBE1 tube2008-12-080000-00-00YesNoCurrent
0299-5908-02002995908022 g in 1 TUBE (0299-5908-02) 2 g2008-12-080000-00-00YesNoCurrent
0299-5908-25002995908251 BOTTLE, PUMP in 1 CARTON (0299-5908-25) / 45 g in 1 BOTTLE, PUMP2008-12-080000-00-00NoNoCurrent
0299-5908-45002995908451 TUBE in 1 CARTON (0299-5908-45) / 45 g in 1 TUBE1 tube2008-12-080000-00-00NoNoCurrent