FDA.reportPublic FDA data

Differin

Product NDC
0299-4910
11-digit product format
002994910
Labeler code
0299
Product ID
0299-4910_7d2ef345-753e-4f6c-bb76-15fae398a44d
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA020380
Marketing category
NDA
Marketing start
2016-07-08
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Differin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui153183, 307731

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
0299-4910-00Differin2 g in 1 TUBEGEL210
0299-4910-00Differin1 in 1 BLISTER PACKGEL110
0299-4910-10Differin15 g in 1 BOTTLE, PUMPGEL1510
0299-4910-10Differin1 in 1 CARTONGEL110
0299-4910-15Differin1 in 1 CARTONGEL110
0299-4910-15Differin15 g in 1 TUBEGEL1510
0299-4910-40Differin45 g in 1 BOTTLE, PUMPGEL4510
0299-4910-40Differin1 in 1 CARTONGEL110
0299-4910-45Differin45 g in 1 TUBEGEL4510
0299-4910-45Differin1 in 1 CARTONGEL110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-4910-15GM - Gram0299-491051b9f33c-ce52-4c6d-b7b6-a2262b14d48a12017-04-05
0299-4910-45GM - Gram0299-4910b6000226-6bf7-4cd1-ac85-128fba44a55512017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-4910DIFFERIN (ADAPALENE) GEL [GALDERMA LABORATORIES, L.P.]10Current NDC, Legacy NDC, 10 package rows20221213_0739d631-171b-42a8-bd55-0022b8df2d8a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN0739d631-171b-42a8-bd55-0022b8df2d8a10
153183Differin 0.1 % Topical GelPSN0739d631-171b-42a8-bd55-0022b8df2d8a10
153183adapalene 0.001 MG/MG Topical Gel [Differin]SBD0739d631-171b-42a8-bd55-0022b8df2d8a10
307731adapalene 0.001 MG/MG Topical GelSCD0739d631-171b-42a8-bd55-0022b8df2d8a10
307731adapalene 0.1 % Topical GelSY0739d631-171b-42a8-bd55-0022b8df2d8a10
153183Differin 0.001 MG/MG Topical GelSY0739d631-171b-42a8-bd55-0022b8df2d8a10
153183Differin 0.1 % Topical GelSY0739d631-171b-42a8-bd55-0022b8df2d8a10
153183Differin 1 MG per GM Topical GelSY0739d631-171b-42a8-bd55-0022b8df2d8a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-4910-00002994910001 TUBE in 1 BLISTER PACK (0299-4910-00) / 2 g in 1 TUBE1 tube2016-07-080000-00-00NoNoCurrent
0299-4910-10002994910101 BOTTLE, PUMP in 1 CARTON (0299-4910-10) / 15 g in 1 BOTTLE, PUMP2020-01-010000-00-00NoNoCurrent
0299-4910-15002994910151 TUBE in 1 CARTON (0299-4910-15) / 15 g in 1 TUBE1 tube2016-07-080000-00-00NoNoCurrent
0299-4910-40002994910401 BOTTLE, PUMP in 1 CARTON (0299-4910-40) / 45 g in 1 BOTTLE, PUMP2020-01-010000-00-00NoNoCurrent
0299-4910-45002994910451 TUBE in 1 CARTON (0299-4910-45) / 45 g in 1 TUBE1 tube2016-07-080000-00-00NoNoCurrent