FDA.reportPublic FDA data

Differin

Product NDC
0299-5915
11-digit product format
002995915
Labeler code
0299
Product ID
0299-5915_e308ee59-596a-4f36-b4b7-85012575041d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene
Dosage form
CREAM
Route
TOPICAL
Labeler
GALDERMA LABORATORIES, L.P
Application
NDA020748
Marketing category
NDA
Marketing start
2009-11-24
Marketing end
2027-05-31
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Differin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui284420, 313852

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
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
0299-5915-45Differin45 g in 1 TUBECREAM458
0299-5915-45Differin1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5915-45GM - Gram0299-5915aceb62d6-9220-449c-92bb-c65240edd2a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
SqualaneINACTIVE INGREDIENTGW89575KF9DIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
TrolamineINACTIVE INGREDIENT9O3K93S3TKDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
ADAPALENEACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
ADAPALENEACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9DIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5915DIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]7Current NDC, Legacy NDC, 2 package rows20221209_ab4b2120-57fc-6c61-b239-37c21789c065.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313852adapalene 0.1 % Topical CreamPSNab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 0.1 % Topical CreamPSNab4b2120-57fc-6c61-b239-37c21789c0658
284420adapalene 1 MG/ML Topical Cream [Differin]SBDab4b2120-57fc-6c61-b239-37c21789c0658
313852adapalene 1 MG/ML Topical CreamSCDab4b2120-57fc-6c61-b239-37c21789c0658
313852adapalene 0.1 % Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 0.1 % Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 1 MG/ML Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5915-45002995915451 TUBE in 1 CARTON (0299-5915-45) / 45 g in 1 TUBE1 tube2009-11-242027-05-31NoNoCurrent