FDA.reportPublic FDA data

Asepxia Acne

Product NDC
50066-063
11-digit product format
500660063
Labeler code
50066
Product ID
50066-063_23e98099-6451-2965-e063-6394a90a697a
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Genomma Lab USA
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-21
Substance
SALICYLIC ACID
Active strength
18.6 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID18.6 mg/mL

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
1146709Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e8de726-480c-44c7-82c8-ce66412d881eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-063-04Asepxia Acne1 in 1 CARTONLIQUID13
50066-063-04Asepxia Acne118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-063ASEPXIA ACNE (SALICYLIC ACID) LIQUID [GENOMMA LAB USA]3Current NDC, 2 package rows20241009_9e8de726-480c-44c7-82c8-ce66412d881e.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 16 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proactiv Renewing CleanserBENZOYL PEROXIDEAlchemee, LLC85c22f3a-b6c5-44a2-959c-532c6456ec302026-01-07WarningsExact identifier
application number: M006
Proactiv Repairing TreatmentBENZOYL PEROXIDEAlchemee, LLC9bbf6db0-ff80-44d2-b81b-40080ca46b922026-01-07WarningsExact identifier
application number: M006
Proactiv Deep Cleansing WashSALICYLIC ACIDTHE PROACTIV COMPANY LLC4a2bd12d-f166-43cf-b175-d20affc805262026-01-07WarningsExact identifier
application number: M006
Proactiv Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
application number: M006
Proactiv Skin Purifying MaskSULFURTHE PROACTIV COMPANY LLC9f0eb12b-4da1-4498-9ffb-de8235264d9b2026-01-07WarningsExact identifier
application number: M006
Proactiv Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
application number: M006
Proactivplus Skin Smoothing ExfoliatorBENZOYL PEROXIDEAlchemee, LLCb56b63d6-5635-4fd4-9517-8b08c3cbf9aa2026-01-07WarningsExact identifier
application number: M006
Proactivplus Smoothing BHA CleanserSALICYLIC ACIDAlchemee, LLC14b9a54c-9993-385e-e063-6394a90a27de2026-01-07WarningsExact identifier
application number: M006
Proactiv Blemish Control Body CreamSALICYLIC ACIDAlchemee, LLC164d2c7f-5f1e-d0a8-e063-6294a90a95f22026-01-07WarningsExact identifier
application number: M006
Proactiv Redness Correcting TreatmentSALICYLIC ACIDAlchemee, LLC25ca582d-158f-2c97-e063-6394a90a56582026-01-07WarningsExact identifier
application number: M006
Proactiv Acne Clearing BodySALICYLIC ACIDAlchemee, LLC22559e3a-3ca4-fb38-e063-6394a90ada9e2026-01-07WarningsExact identifier
application number: M006
Proactiv MD KitMD KITAlchemee, LLC1d142dba-145c-fb33-e063-6394a90a88b62026-01-07WarningsExact identifier
application number: M006
Proactiv Clean Beginner BundleCLEAN KITAlchemee, LLC201e1b5e-555a-92c0-e063-6394a90a13602026-01-07WarningsExact identifier
application number: M006
Proactiv Plus KitSOLUTIONS KITAlchemee, LLC1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42026-01-07WarningsExact identifier
application number: M006
Proactiv Solution KitSOLUTIONS KITAlchemee, LLC17f359a0-04a2-d112-e063-6394a90a27352026-01-07WarningsExact identifier
application number: M006
Universal Clarifying PadSALICYLIC ACIDAllure Labs47d3c57c-d6d2-a9e0-e063-6294a90a3b5b2026-01-07WarningsExact identifier
application number: M006
Earths Care Acne Treatment MaskSULFURDLC Laboratories, Inc.f067e85e-0475-4108-ad93-2af7717ead3e2026-01-07WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.aa1f2afe-7b09-4448-b522-e1b23d63d3ef2026-01-07WarningsExact identifier
application number: M006
Joesoef Skincare Anti AcneSULFURPT Galenium Pharmasia Laboratoriesd9b7acd4-f0dd-c28b-e053-2a95a90a4c302026-01-05WarningsExact identifier
application number: M006
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1146709salicylic acid 1.86 % Topical LotionPSN9e8de726-480c-44c7-82c8-ce66412d881e3
1146709salicylic acid 18.6 MG/ML Topical LotionSCD9e8de726-480c-44c7-82c8-ce66412d881e3
1146709salicylic acid 1.86 % Topical LotionSY9e8de726-480c-44c7-82c8-ce66412d881e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50066-063-04500660063041 BOTTLE, PLASTIC in 1 CARTON (50066-063-04) / 118 mL in 1 BOTTLE, PLASTIC2024-06-21NoNoCurrent