FDA.reportPublic FDA data

Acne Gel

Manufacturer
SKIN PLUS, LIMITED LIABILITY COMPANY | Freelance Formulations LLC
Effective date
2023-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:24

Label at a glance#

ProductAcne Gel
Active ingredientBENZOYL PEROXIDE
Label structure1 sections

Label contents#

Full prescribing information#

Acne Gel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Acne GelAcne Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN1
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD1
308694benzoyl peroxide 5 % Topical GelSY1

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
82172-230-302023-07-28C16284748780-10191ceaa-6e8d-198a-e063-dbdaa90aec3eAcne Gel 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82172-230-30Acne Gel30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82172-230ACNE GEL (BENZOYL PEROXIDE) GEL [SKIN PLUS, LIMITED LIABILITY COMPANY]11 package rows20230308_f4c8b694-cde5-3b39-e053-2a95a90ac283.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82172-23082172-230-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
SODIUM HYDROXIDE55X04QC32IIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOMER 9404Q93RCW27EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4c8b694-cde6-3b39-e053-2a95a90ac283f4c8b694-cde5-3b39-e053-2a95a90ac2832023-02-15WarningsExact identifier
spl id: f4c8b694-cde6-3b39-e053-2a95a90ac283
spl set id: f4c8b694-cde5-3b39-e053-2a95a90ac283

Reported adverse events (FAERS/openFDA)#

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