FDA.reportPublic FDA data

Asepxia Oil-Free Acne Bar

Product NDC
50066-803
11-digit product format
500660803
Labeler code
50066
Product ID
50066-803_09891759-b190-6a81-e063-6394a90a2f89
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
SOAP
Route
TOPICAL
Labeler
Genomma Lab USA
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-19
Substance
SALICYLIC ACID
Active strength
2 g/100g
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 Oil-Free Acne Bar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100g

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
312882Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b3a9224-f250-45e9-a1fe-a54940c6f93bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-803-012020-03-23C16284748780-19d75b9d0-c067-f424-e053-dadaa90a57ceAsepxia Oil-Free Acne Bar Soap ®
50066-803-012020-01-31C16284748780-19d75b9d0-c067-f424-e053-dadaa90a57ceAsepxia Oil-Free Acne Bar Soap ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-803-01Asepxia Oil-Free Acne Bar113 g in 1 APPLICATORSOAP1134
50066-803-01Asepxia Oil-Free Acne Bar1 in 1 CARTONSOAP14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-803ASEPXIA OIL-FREE ACNE BAR (SALICYLIC ACID) SOAP [GENOMMA LAB USA]4Current NDC, Legacy NDC, 2 package rows20231108_0b3a9224-f250-45e9-a1fe-a54940c6f93b.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 47 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Peace Out AcneSALICYLIC ACIDPeace Out LLC.eac771e2-4c1a-3808-e053-2995a90ac5fc2024-05-20WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Pore Clearing Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe2024-05-09WarningsExact identifier
application number: M006
Walgreens Creamy Acne Face Wash Acne MedicationBENZOYL PEROXIDEWalgreen Company13e5396b-839b-4c08-a98f-f0a36c9a0bff2024-05-09WarningsExact identifier
application number: M006
Bubble Knock Out Acne Spot TreatmentSALICYLIC ACIDBUBBLE BEAUTY17cf44cf-55f1-86a5-e063-6294a90a35d22024-05-06WarningsExact identifier
application number: M006
Bubble Super Clear Blemish Prevention SerumSALICYLIC ACIDBUBBLE BEAUTY1790ad12-c947-ddc0-e063-6394a90a85692024-05-03WarningsExact identifier
application number: M006
Walgreens Daily Acne Cleanser- Sensitive Skin FormulaBENZOYL PEROXIDEWalgreen Companyacae5006-e647-4f00-b93a-2c0bceee14cb2024-05-01WarningsExact identifier
application number: M006
Derma E Acne Blemish Control Treatment SerumSALICYLIC ACIDderma ebf5f489d-07c6-47b8-ae76-701e7ad92e8d2024-04-30WarningsExact identifier
application number: M006
Pacifica Clear Mist Facial AcneSALICYLIC ACIDPacifica Beauty, LLC16ee1a80-d523-1d02-e063-6394a90a94592024-04-25WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f3cd004d-32f1-4888-8129-d355a4750b252024-03-24WarningsExact identifier
application number: M006
Lacura Blemish Dots Conceal and TreatSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.15c447b5-0e51-43e7-b697-683bc0e686c02024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c61e100b-a141-45b3-842b-855be28b02262024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f5c5a2df-11c5-4134-bf1f-b505642164492024-03-20WarningsExact identifier
application number: M006
Blemish Control Dots aloe veraSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.4722ff71-7d9f-4ef2-9f8b-3614e80b864f2024-03-20WarningsExact identifier
application number: M006
Blemish Control DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b2024-03-20WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ca0e6b50-2995-41f8-b944-9f166aac05112024-03-13WarningsExact identifier
application number: M006
Maximum Sterngth Cleansing Pads EquateSALICYLIC ACIDWalmart7db929b6-6470-4840-b016-7e19688548dd2024-03-11WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree OilSALICYLIC ACIDRejoice International7ae434d1-8b07-4121-9163-df07598d41562024-02-28WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312882salicylic acid 2 % Medicated Bar SoapPSN0b3a9224-f250-45e9-a1fe-a54940c6f93b4
312882salicylic acid 0.02 MG/MG Medicated Bar SoapSCD0b3a9224-f250-45e9-a1fe-a54940c6f93b4
312882salicylic acid 2 % Medicated Bar SoapSY0b3a9224-f250-45e9-a1fe-a54940c6f93b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50066-803-01500660803011 APPLICATOR in 1 CARTON (50066-803-01) / 113 g in 1 APPLICATOR1 applicator2020-03-190000-00-00NoNoCurrent