Replenix Acne

Product NDC
51326-411
11-digit product format
513260411
Labeler code
51326
Product ID
51326-411_3f4c6873-4988-477e-b77e-0d4d981eb76d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Topiderm, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-01-22
Substance
BENZOYL PEROXIDE
Active strength
50 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui308694

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51326-411-572023-10-17C16284748780-1f386c649-b378-0266-e053-dadaa90a7c1aReplenix ® Acne Gel 5%
51326-411-572023-01-30C16284748780-1f386c649-b378-0266-e053-dadaa90a7c1aReplenix ® Acne Gel 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51326-411-57Replenix Acne57 g in 1 TUBEGEL573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51326-411REPLENIX ACNE (BENZOYL PEROXIDE) GEL [TOPIDERM, INC]3Current NDC, Legacy NDC, 1 package rows20231108_03d4c298-8f44-41f7-b086-96ae836152bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSN03d4c298-8f44-41f7-b086-96ae836152bb3
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD03d4c298-8f44-41f7-b086-96ae836152bb3
308694benzoyl peroxide 5 % Topical GelSY03d4c298-8f44-41f7-b086-96ae836152bb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51326-411-575132604115757 g in 1 TUBE (51326-411-57) 57 g1993-01-220000-00-00NoNoCurrent