Proactiv MD Adapalene

Product NDC
11410-958
11-digit product format
114100958
Labeler code
11410
Product ID
11410-958_47d20188-59f7-d011-e063-6294a90a39fa
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Alchemee, LLC
Application
ANDA215940
Marketing category
ANDA
Marketing start
2023-11-16
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
Proactiv MD Adapalene
Brand name suffix
Acne Treatment
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-958-15Proactiv MD AdapaleneAcne Treatment15 g in 1 TUBEGEL155
11410-958-15Proactiv MD AdapaleneAcne Treatment1 in 1 BOXGEL15
11410-958-45Proactiv MD AdapaleneAcne Treatment1 in 1 BOXGEL15
11410-958-45Proactiv MD AdapaleneAcne Treatment45 g in 1 TUBEGEL455
11410-958-15Proactiv MD Kit15 g in 1 TUBEGEL15 g in 1000.1 g in 100g2
11410-958-15Proactiv MD Kit1 in 1 BOXGEL0.1 g in 100g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11410-958PROACTIV MD ADAPALENE ACNE TREATMENT (ADAPALENE) GEL [ALCHEMEE, LLC]3Current NDC, 4 package rows20250309_0a9b3755-c0db-4282-e063-6394a90a0c08.zip
11410-958PROACTIV MD KIT (MD KIT) KIT [ALCHEMEE, LLC]1Current NDC20240726_1d142dba-145c-fb33-e063-6394a90a88b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN0a9b3755-c0db-4282-e063-6394a90a0c085
307731adapalene 0.001 MG/MG Topical GelSCD0a9b3755-c0db-4282-e063-6394a90a0c085
307731adapalene 0.1 % Topical GelSY0a9b3755-c0db-4282-e063-6394a90a0c085
307731adapalene 0.1 % Topical GelPSN1d142dba-145c-fb33-e063-6394a90a88b62
307731adapalene 0.001 MG/MG Topical GelSCD1d142dba-145c-fb33-e063-6394a90a88b62
307731adapalene 0.1 % Topical GelSY1d142dba-145c-fb33-e063-6394a90a88b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11410-958-15114100958151 TUBE in 1 BOX (11410-958-15) / 15 g in 1 TUBE1 tube2023-11-16NoNoHistorical
11410-958-45114100958451 TUBE in 1 BOX (11410-958-45) / 45 g in 1 TUBE1 tube2023-11-16NoNoHistorical