FDA.reportPublic FDA data

Ultra Clear Foaming Cleanser

Product NDC
10028-050
Requested package NDC
10028-050-01
11-digit product format
100280050
Labeler code
10028
Product ID
10028-050_5d485fe4-214b-d3fc-e063-6294a90a0203
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
Ultraceuticals Pty Ltd
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-11
Substance
SALICYLIC ACID
Active strength
.5 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Ultra Clear Foaming Cleanser
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.5 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10028-050-012023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-09-01Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-07-28Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-02-17Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-012023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser
10028-050-022023-01-30Ultra Clear Foaming Cleanser Acne Face Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10028-050-01Ultra Clear Foaming Cleanser150 mL in 1 BOTTLELOTION1507
10028-050-02Ultra Clear Foaming Cleanser50 mL in 1 BOTTLELOTION507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10028-050ULTRA CLEAR FOAMING CLEANSER (SALICYLIC ACID) LOTION [ULTRACEUTICALS PTY LIMITED]6Current NDC, Legacy NDC, 2 package rows20241025_98d0def0-393d-1ebb-e053-2995a90a2513.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 22 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPPORT SERUM FORTIFIEDSULFURZENMED Raging Creations Ltd.26e5777d-4ce2-458c-90f1-4c23c7b571ed2025-11-10WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Spot GelSALICYLIC ACIDTHG Beauty USA LLC1f92122d-4873-8c1a-e063-6294a90a1c3b2025-11-07WarningsExact identifier
application number: M006
Perricone MD Acne Relief Maximum Strength Clearing TreatmentSALICYLIC ACIDTHG Beauty USA LLC1f4108da-c83b-4b1d-e063-6294a90abfd72025-11-07WarningsExact identifier
application number: M006
e.l.f Skin Acne-Treating Body MistSALICYLIC ACIDe.l.f. Cosmetics, Incf575b71f-d2bf-7469-e053-2995a90a02eb2025-11-07WarningsExact identifier
application number: M006
Naturium Benzoyl Peroxide Cleanser 5%BENZOYL PEROXIDEe.l.f. Cosmetics, Inc0a278590-e98b-7cab-e063-6394a90a4d0e2025-11-07WarningsExact identifier
application number: M006
Clear Smart Charcoal Blackhead ScrubSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.5e13ccf6-f66a-475f-aaf8-6609369c36a82025-11-05WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories54ebb0ba-e32c-4b8e-8427-b947ca6441502025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories42e9bea8-e840-4163-929e-967baf5f2f902025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories1ac05b1f-d508-4e9b-bef1-22e522ad740f2025-11-03WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Wash Acne MedicationBENZOYL PEROXIDERugby Laboratories5af89ec6-0f4a-451a-8a45-5194115dc8282025-11-03WarningsExact identifier
application number: M006
AOSORW Folliculitis and Acne Treatment CreamFOLLICULITIS AND ACNE TREATMENT CREAMSpineStatus LLC3a07f7dd-8159-46b1-e063-6294a90a774b2025-11-03WarningsExact identifier
application number: M006
Mild By Nature ACNE FOAMING CLEANSERACNE FOAMING CLEANSERIHerb, LLC42b6187e-ef98-7be5-e063-6394a90a5e0f2025-11-03WarningsExact identifier
application number: M006
Dermacleanse Acne Spot TreatmentSALICYLIC ACIDZENMED Raging Creations Ltd.3f691959-a37b-430c-8135-27f086c650562025-11-03WarningsExact identifier
application number: M006
Perricone MD Acne Relief Gentle and Soothing CleanserSALICYLIC ACIDTHG Beauty USA LLC1f3d93f0-3a53-d6f0-e063-6394a90a2aff2025-10-31WarningsExact identifier
application number: M006
Perricone MD Acne Relief Calming Treatment and Hydrator Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21eafafe-18ea-08d3-e063-6294a90abb852025-10-30WarningsExact identifier
application number: M006
OXY Deep Pore Cleansing PadsSALICYLIC ACIDThe Mentholatum Companyedaf76d4-1e9b-4397-96af-25a5252675e32025-10-29WarningsExact identifier
application number: M006
Perricone MD Acne Relief Gentle Exfoliating Toner Salicylic Acid Acne TreatmentSALICYLIC ACIDTHG Beauty USA LLC21ea9a55-0a1f-47f7-e063-6294a90aa2692025-10-28WarningsExact identifier
application number: M006
BENZOYL PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
application number: M006
Perricone MD Acne Relief Retinol Treatment and MoisturizerSALICYLIC ACIDTHG Beauty USA LLC41ac6e4e-59ad-6d80-e063-6394a90adc012025-10-21WarningsExact identifier
application number: M006
Clear Smart Blemish Spot TreatmentSALICYCLIC ACIDDistribuidora Comercial Jafra, S.A. de C.Va568186c-543b-5d44-e053-2995a90aa4912025-10-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
865105salicylic acid 0.5 % Medicated Liquid SoapPSN98d0def0-393d-1ebb-e053-2995a90a25137
865105salicylic acid 5 MG/ML Medicated Liquid SoapSCD98d0def0-393d-1ebb-e053-2995a90a25137
865105salicylic acid 0.5 % Foaming CleanserSY98d0def0-393d-1ebb-e053-2995a90a25137
865105salicylic acid 0.5 % MaskSY98d0def0-393d-1ebb-e053-2995a90a25137
865105salicylic acid 0.5 % Medicated Liquid SoapSY98d0def0-393d-1ebb-e053-2995a90a25137
865105salicylic acid 0.5 % Topical Gel CleanserSY98d0def0-393d-1ebb-e053-2995a90a25137

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10028-050-0110028005001150 mL in 1 BOTTLE (10028-050-01) 150 ml2019-12-110000-00-00NoNoCurrent