FDA.reportPublic FDA data

Curist Acne Relief

Product NDC
72559-015
11-digit product format
725590015
Labeler code
72559
Product ID
72559-015_4821e693-2293-b60e-e063-6294a90a7d86
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Little Pharma, Inc.
Application
ANDA091314
Marketing category
ANDA
Marketing start
2022-08-15
Substance
ADAPALENE
Active strength
.1 g/100g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Curist Acne Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1L4806J2QF
Rxcui307731

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
72559-015-13Curist Acne Relief45 g in 1 TUBEGEL453
72559-015-13Curist Acne Relief1 in 1 CARTONGEL13
72559-015-17Curist Acne Relief2 in 1 PACKAGE, COMBINATIONGEL23
72559-015-17Curist Acne Relief1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72559-015CURIST ACNE RELIEF (ADAPALENE) GEL [LITTLE PHARMA, INC.]2Current NDC, Legacy NDC, 4 package rows20241107_e6380880-5299-0826-e053-2a95a90a1942.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSNe6380880-5299-0826-e053-2a95a90a19423
307731adapalene 0.001 MG/MG Topical GelSCDe6380880-5299-0826-e053-2a95a90a19423
307731adapalene 0.1 % Topical GelSYe6380880-5299-0826-e053-2a95a90a19423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72559-015-13725590015131 TUBE in 1 CARTON (72559-015-13) / 45 g in 1 TUBE1 tube2022-08-150000-00-00NoNoCurrent
72559-015-17725590015172 CARTON in 1 PACKAGE, COMBINATION (72559-015-17) / 1 TUBE in 1 CARTON / 45 g in 1 TUBE2 carton2024-06-21NoNoHistorical