FDA.reportPublic FDA data

Acne Med 5%

Product NDC
70707-211
11-digit product format
707070211
Labeler code
70707
Product ID
70707-211_0c8655bc-43b2-2b67-e063-6394a90aafa3
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Face Reality, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Med 5%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/mL

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
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
70707-211-15Acne Med 5%1 in 1 CARTONGEL15
70707-211-15Acne Med 5%44 mL in 1 BOTTLE, WITH APPLICATORGEL445

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-211ACNE MED 5% (BENZOYL PEROXIDE) GEL [FACE REALITY, LLC]5Current NDC, Legacy NDC, 2 package rows20231215_454983d2-4b11-6268-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSN454983d2-4b11-6268-e054-00144ff8d46c5
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD454983d2-4b11-6268-e054-00144ff8d46c5
308694benzoyl peroxide 5 % Topical GelSY454983d2-4b11-6268-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70707-211-017070702110130 mL in 1 TUBE (70707-211-01) 30 ml2016-12-300000-00-00NoNoCurrent
70707-211-027070702110260 mL in 1 TUBE (70707-211-02) 60 ml2016-12-300000-00-00NoNoCurrent
70707-211-15707070211151 BOTTLE, WITH APPLICATOR in 1 CARTON (70707-211-15) / 44 mL in 1 BOTTLE, WITH APPLICATOR2023-01-01NoNoHistorical