FDA.reportPublic FDA data

DIFFERIN

Product NDC
0299-5918
11-digit product format
002995918
Labeler code
0299
Product ID
0299-5918_cc125ed9-1ac8-491e-8eba-bd55426fc825
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA021753
Marketing category
NDA
Marketing start
2009-09-15
Marketing end
2027-02-01
Substance
ADAPALENE
Active strength
3 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
ADAPALENE3 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui722111, 722113

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
0299-5918-02DIFFERIN2 g in 1 TUBEGEL212
0299-5918-15DIFFERIN1 in 1 CARTONGEL112
0299-5918-15DIFFERIN15 g in 1 TUBEGEL1512
0299-5918-25DIFFERIN1 in 1 CARTONGEL112
0299-5918-25DIFFERIN45 g in 1 BOTTLE, PUMPGEL4512
0299-5918-45DIFFERIN1 in 1 CARTONGEL112
0299-5918-45DIFFERIN45 g in 1 TUBEGEL4512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5918-25GM - Gram0299-591827ec8349-9bed-432a-afe3-d801b233153912013-02-13
0299-5918-45GM - Gram0299-59183fdd8c1a-9bc0-4af0-9503-2165de1c206b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
ADAPALENEACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Carbomer Homopolymer Type CINACTIVE INGREDIENT4Q93RCW27EDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Poloxamer 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]8
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 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5918DIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]12Current NDC, Legacy NDC, 7 package rows20240113_a0031324-92a6-4c11-90e2-c2818f7278ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
722111adapalene 0.3 % Topical GelPSNa0031324-92a6-4c11-90e2-c2818f7278ec12
722113Differin 0.3 % Topical GelPSNa0031324-92a6-4c11-90e2-c2818f7278ec12
722113adapalene 0.003 MG/MG Topical Gel [Differin]SBDa0031324-92a6-4c11-90e2-c2818f7278ec12
722111adapalene 0.003 MG/MG Topical GelSCDa0031324-92a6-4c11-90e2-c2818f7278ec12
722111adapalene 0.3 % Topical GelSYa0031324-92a6-4c11-90e2-c2818f7278ec12
722113Differin 0.003 MG/MG Topical GelSYa0031324-92a6-4c11-90e2-c2818f7278ec12
722113Differin 0.3 % Topical GelSYa0031324-92a6-4c11-90e2-c2818f7278ec12
722113Differin 3 MG per GM Topical GelSYa0031324-92a6-4c11-90e2-c2818f7278ec12
722111adapalene 0.3 % Topical GelPSN5183ead4-9735-4535-b4f1-8dcb417eef022
722113Differin 0.3 % Topical GelPSN5183ead4-9735-4535-b4f1-8dcb417eef022
722113adapalene 0.003 MG/MG Topical Gel [Differin]SBD5183ead4-9735-4535-b4f1-8dcb417eef022
722111adapalene 0.003 MG/MG Topical GelSCD5183ead4-9735-4535-b4f1-8dcb417eef022
722111adapalene 0.3 % Topical GelSY5183ead4-9735-4535-b4f1-8dcb417eef022
722113Differin 0.003 MG/MG Topical GelSY5183ead4-9735-4535-b4f1-8dcb417eef022
722113Differin 0.3 % Topical GelSY5183ead4-9735-4535-b4f1-8dcb417eef022
722113Differin 3 MG per GM Topical GelSY5183ead4-9735-4535-b4f1-8dcb417eef022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5918-02002995918022 g in 1 TUBE (0299-5918-02) 2 g2009-09-150000-00-00NoNoCurrent
0299-5918-15002995918151 TUBE in 1 CARTON (0299-5918-15) > 15 g in 1 TUBE1 tube2009-09-150000-00-00NoNoCurrent
0299-5918-25002995918251 BOTTLE, PUMP in 1 CARTON (0299-5918-25) / 45 g in 1 BOTTLE, PUMP2009-09-152027-02-01NoNoCurrent
0299-5918-45002995918451 TUBE in 1 CARTON (0299-5918-45) > 45 g in 1 TUBE1 tube2009-09-150000-00-00NoNoCurrent