Biba Acne

Product NDC
83834-001
11-digit product format
838340001
Labeler code
83834
Product ID
83834-001_2fc8f2d1-1146-7720-e063-6294a90a7467
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Esthetic Underground, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-15
Marketing end
2026-07-15
Substance
BENZOYL PEROXIDE
Active strength
2.5 g/100mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Biba Acne

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE2.5 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW9WZN9A0GM
Rxcui308689

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83834-001-01Biba Acne30 mL in 1 BOTTLE, PUMPGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83834-001BIBA ACNE (BENZOYL PEROXIDE) GEL [ESTHETIC UNDERGROUND, INC.]2Current NDC, 1 package rows20250309_448eeb45-e6a2-43da-bd04-9844aa0b5dff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN448eeb45-e6a2-43da-bd04-9844aa0b5dff2
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD448eeb45-e6a2-43da-bd04-9844aa0b5dff2
308689benzoyl peroxide 2.5 % Topical GelSY448eeb45-e6a2-43da-bd04-9844aa0b5dff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83834-001-018383400010130 mL in 1 BOTTLE, PUMP (83834-001-01) 30 ml2024-07-152026-07-15NoNoHistorical