FDA.reportPublic FDA data

Differin

Product NDC
0299-5912
11-digit product format
002995912
Labeler code
0299
Product ID
0299-5912_676f04a0-99a9-484f-9d40-62f710ea7fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA022502
Marketing category
NDA
Marketing start
2010-03-31
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
0 g/100mL
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5912-02ML - Milliliter0299-59122f2d7727-e3b8-4ee4-82ee-45fa779ca38612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Carbomer Homopolymer Type AINACTIVE INGREDIENTF68VH75CJCDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Medium-chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Poloxamer 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ADIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Carbomer Homopolymer Type AINACTIVE INGREDIENTF68VH75CJCDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Medium-chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Poloxamer 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5912DIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]14Legacy NDC20241027_78b3c1f9-0fc2-4075-6cf0-454a492e6ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905385adapalene 0.1 % Topical LotionPSN5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 0.1 % Topical LotionPSN5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387adapalene 1 MG/ML Topical Lotion [Differin]SBD5c7981be-509d-4dc1-a6b6-78e047942cdd2
905385adapalene 1 MG/ML Topical LotionSCD5c7981be-509d-4dc1-a6b6-78e047942cdd2
905385adapalene 0.1 % Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 0.1 % Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 1 MG/ML Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5912-010029959120115 mL in 1 BOTTLE (0299-5912-01) 15 ml2010-04-270000-00-00NoNoCurrent
0299-5912-02002995912021 BOTTLE, PUMP in 1 CARTON (0299-5912-02) > 59 mL in 1 BOTTLE, PUMP2010-04-270000-00-00NoNoCurrent