FDA.reportPublic FDA data

5 Acne Med

Product NDC
70707-155
Requested package NDC
70707-155-15
11-digit product format
707070155
Labeler code
70707
Product ID
70707-155_d12b0cdb-222a-2cdc-e053-2a95a90ad411
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Face Reality, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-10-15
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70707-15570707-155-15DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
70707-155-155 Acne Med1 in 1 CARTONGEL13
70707-155-155 Acne Med44 mL in 1 TUBEGEL443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-1555 ACNE MED (BENZOYL PEROXIDE) GEL [FACE REALITY, INC.]3Legacy NDC, 2 package rows20240606_d860756d-d74a-4d50-8af0-4ccbcc756a88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNd860756d-d74a-4d50-8af0-4ccbcc756a883
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDd860756d-d74a-4d50-8af0-4ccbcc756a883
308694benzoyl peroxide 5 % Topical GelSYd860756d-d74a-4d50-8af0-4ccbcc756a883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70707-155-15707070155151 TUBE in 1 CARTON (70707-155-15) > 44 mL in 1 TUBE1 tube2011-10-150000-00-00NoNoCurrent