FDA.reportPublic FDA data

DIFFERIN

Product NDC
0299-5910
11-digit product format
002995910
Labeler code
0299
Product ID
0299-5910_79d4f186-a6fc-4fe5-9ca6-246c32317efd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA020380
Marketing category
NDA
Marketing start
1996-05-31
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
0299-5910-45GM - Gram0299-59108007b5fa-60c6-410d-af6a-5a43533254be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
adapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
adapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Carbomer Homopolymer Type CINACTIVE INGREDIENT4Q93RCW27EDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Edetate disodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Hydrochloric acidINACTIVE INGREDIENTQTT17582CBDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Poloxamer 182INACTIVE INGREDIENTJX0HIX6OAGDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) GEL [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSNe616d076-9e99-46ea-b69a-5858673341422
153183Differin 0.1 % Topical GelPSNe616d076-9e99-46ea-b69a-5858673341422
153183adapalene 0.001 MG/MG Topical Gel [Differin]SBDe616d076-9e99-46ea-b69a-5858673341422
307731adapalene 0.001 MG/MG Topical GelSCDe616d076-9e99-46ea-b69a-5858673341422
307731adapalene 0.1 % Topical GelSYe616d076-9e99-46ea-b69a-5858673341422
153183Differin 0.001 MG/MG Topical GelSYe616d076-9e99-46ea-b69a-5858673341422
153183Differin 0.1 % Topical GelSYe616d076-9e99-46ea-b69a-5858673341422
153183Differin 1 MG per GM Topical GelSYe616d076-9e99-46ea-b69a-5858673341422