FDA.reportPublic FDA data

Asepxia Acne Treatment

Product NDC
50066-064
11-digit product format
500660064
Labeler code
50066
Product ID
50066-064_23f810d6-c9d8-4ef6-e063-6294a90aeaf2
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
Genomma Lab USA
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-05
Substance
SALICYLIC ACID
Active strength
20 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Asepxia Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
910d4320-bf89-436a-a8d4-54d001281deeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-064-01Asepxia Acne Treatment1 in 1 CARTONCREAM13
50066-064-01Asepxia Acne Treatment28 g in 1 TUBECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-064ASEPXIA ACNE TREATMENT (SALICYLIC ACID) CREAM [GENOMMA LAB USA]3Current NDC, 2 package rows20241010_910d4320-bf89-436a-a8d4-54d001281dee.zip

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 21 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Shaant Pore Purifying Face ScrubSALICYLIC ACIDCodex Labs Corporationd806e749-ea2c-4db4-af65-a1f8afce1b0e2025-11-21WarningsExact identifier
application number: M006
Shaant Spot Hero Drying Acne TreatmentSULFURCodex Labs Corporation24fa844b-e4ce-46de-a2d6-e9e863888a552025-11-21WarningsExact identifier
application number: M006
Shaant Hydrating Body ScrubSALICYLIC ACIDCodex Labs Corporation64a176a1-7dc4-44f8-8b3d-4349460a17b02025-11-21WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.4401fff2-725f-8ff0-e063-6294a90ae9ba2025-11-20WarningsExact identifier
application number: M006
CAVOREAL Plus Salicylic Acid Anti Acne with BHA HASALICYLIC ACIDGuangzhou Meijiao Medical Biotechnology Co., Ltd.440a3a73-7136-f8b2-e063-6394a90a744d2025-11-20WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming and Soothing Clay MaskSALICYLIC ACIDTHG Beauty USA LLC23a3d093-e89b-ddaf-e063-6394a90aaa6a2025-11-14WarningsExact identifier
application number: M006
Daily MedsSALICYLIC ACIDBioelements, Inc.3ffb6cd0-c529-4420-8da8-de52838d8a642025-11-14WarningsExact identifier
application number: M006
Naturium Encapsulated Salicylic Acid Moisturizer 0.75%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a4a0de1-6feb-bf9a-e063-6394a90a32d92025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Body 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a5b80fb-caec-eb56-e063-6294a90a238b2025-11-14WarningsExact identifier
application number: M006
Naturium Salicylic Acid Serum 2%SALICYLIC ACIDe.l.f. Cosmetics, Inc0a28640e-37f8-9a74-e063-6294a90a15b72025-11-14WarningsExact identifier
application number: M006
Naturium Sulfur Spot Treatment 8%SULFURe.l.f. Cosmetics, Inc0a4a9aed-5eeb-f648-e063-6394a90a1d762025-11-14WarningsExact identifier
application number: M006
Acne Spot TreatmentSALICYLIC ACID ACNE TREATMENTCosMedical Technologies23bd8842-5237-4131-e054-00144ff8d46c2025-11-13WarningsExact identifier
application number: M006
Overnight Spot TreatmentACNE TREATMENTCosMedical Technologies23bde802-d84a-1ecc-e054-00144ff88e882025-11-13WarningsExact identifier
application number: M006
Personox Ultimate Scrub CleanserSALICYLIC ACIDStonebridge Consultants LLC2b8b5134-ad05-3345-e063-6294a90a87512025-11-12WarningsExact identifier
application number: M006
Clinicians ComplexSULFURCosmed Dermaceuticals, Inc.256e3e4e-2219-45f8-ab78-a6a541767de82025-11-11WarningsExact identifier
application number: M006
CLEARSYNERGYSALICYLIC ACIDSRL ENTERPRISES LLCdf0a4398-4c21-421a-a7dd-92149b1dc8a62025-11-11WarningsExact identifier
application number: M006
Clinicians ComplexSULFURSkinSx.com, Inc.0f13770a-774b-49ad-8417-02928371682a2025-11-11WarningsExact identifier
application number: M006
AzelaqSALICYLIC ACIDMETHODIQ INC.43084456-e452-07d9-e063-6294a90a36c82025-11-10WarningsExact identifier
application number: M006
DapinaqSALICYLIC ACIDMETHODIQ INC.43417b1a-ff07-32da-e063-6294a90aa9032025-11-10WarningsExact identifier
application number: M006
DuolaqSALICYLIC ACIDMETHODIQ INC.4341d931-897d-c298-e063-6394a90a4d6f2025-11-10WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSN910d4320-bf89-436a-a8d4-54d001281dee3
317152salicylic acid 20 MG/ML Topical CreamSCD910d4320-bf89-436a-a8d4-54d001281dee3
317152salicylic acid 2 % Topical CreamSY910d4320-bf89-436a-a8d4-54d001281dee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50066-064-01500660064011 TUBE in 1 CARTON (50066-064-01) / 28 g in 1 TUBE1 tube2024-09-05NoNoCurrent