FDA.reportPublic FDA data

MEDPURA Benzoyl Peroxide

Product NDC
71399-9234
11-digit product format
713999234
Labeler code
71399
Product ID
71399-9234_4849d778-5066-277d-e063-6294a90a798a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Akron Pharma Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-13
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEDPURA Benzoyl Peroxide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui142034, 308696

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
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
71399-9234-52023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-82023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-52023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-82023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-9234-5MEDPURA Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484
71399-9234-8MEDPURA Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-9234-5GM - Gram71399-9234df744d6d-319b-46ad-b3a9-c346997d6d4412021-12-08
71399-9234-8GM - Gram71399-9234e565aaaf-8150-49ab-a5fd-c211d0321f6e12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-9234MEDPURA BENZOYL PEROXIDE (BENZOYL PEROXIDE) LIQUID [AKRON PHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20240922_1b051efe-054b-42a0-915a-b87885bd3c54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN1b051efe-054b-42a0-915a-b87885bd3c544
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN1b051efe-054b-42a0-915a-b87885bd3c544
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD1b051efe-054b-42a0-915a-b87885bd3c544
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD1b051efe-054b-42a0-915a-b87885bd3c544
142034benzoyl peroxide 10 % Medicated Liquid SoapSY1b051efe-054b-42a0-915a-b87885bd3c544
308696benzoyl peroxide 5 % Medicated Liquid SoapSY1b051efe-054b-42a0-915a-b87885bd3c544

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-9234-571399923405148 mL in 1 BOTTLE (71399-9234-5) 148 ml2024-09-130000-00-00NoNoCurrent
71399-9234-871399923408237 mL in 1 BOTTLE (71399-9234-8) 237 ml2024-09-130000-00-00NoNoCurrent