FDA.reportPublic FDA data

Ultra Clear Foaming Cleanser

Product NDC
10028-050
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 51 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILANI ERASE BASE BLEMISH CONTROL PRIMER Salicylic AcidSALICYLIC ACIDNew Milani Group, LLCc2d43609-8a7a-4e54-8e8c-66115948dba22023-12-12WarningsExact identifier
application number: M006
Differin Daily Deep Cleanser with BPOBENZOYL PEROXIDEGalderma Laboratories, L.P.192b231b-51f1-457c-9a82-ef75671c0d342023-12-11WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION04df2f5d-77f0-4553-9d8c-3f10628736ae2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Inc4acae53c-3250-4703-83ac-f158562926c62023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body ScrubSALICYLIC ACIDGalderma Laboratories, L.P.b1e9f483-80ad-49f1-974e-4732bacd96392023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONa2369870-cf81-4ebd-a354-858212d67d0e2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Daily Deep CleansingSALICYLIC ACIDL'Oreal USA Products Inc0db3a8cb-7691-4772-9f7d-15de66098e2e2023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing Body WashSALICYLIC ACIDGalderma Laboratories, L.P.b280351f-02d4-4456-85b5-905e835968482023-12-11WarningsExact identifier
application number: M006
Differin Acne Clearing BodySALICYLIC ACIDGalderma Laboratories, L.P.ce4d1074-5f74-4ad7-9535-2737f5fff24f2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control Daily MoisturizerSALICYLIC ACIDL'Oreal USA Products Incb7d0d094-6a5b-4776-9f13-1f8d305424762023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Deep CleansingSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb61a3f74-a588-47f4-b4a5-c8f97f98d9dd2023-12-11WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm BHA Exfoliating Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incc6f5e9a4-c938-4c44-ace7-a9688b227d592023-12-11WarningsExact identifier
application number: M006
Clarifying TonerSALICYLIC ACIDAllure Labs0c07e6e9-18c1-20da-e063-6294a90aa3c82023-12-08WarningsExact identifier
application number: M006
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
application number: M006
Foaming CleanserSALICYLIC ACIDAllure Labs0bf4c2d8-2fbf-a1c4-e063-6294a90ac1302023-12-07WarningsExact identifier
application number: M006
CLEAROGEN 3BENZOYL PEROXIDEAllure Labs0bdf9f38-5763-a4d0-e063-6394a90a41dc2023-12-06WarningsExact identifier
application number: M006
REPLENIX ACNE 10% WASH PARABEN FREE WITH ALOEBENZOYL PEROXIDETopiderm, Inc.ea9a32c4-3795-4718-9394-bac69091c7322023-12-04WarningsExact identifier
application number: M006
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
application number: M006
Cetaphil Gentle Clear BPO Acne CleanserBENZOYL PEROXIDEGalderma Laboratories, L.P.6397f20f-d69f-47e4-a123-4cc7e1abfcad2023-11-29WarningsExact 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
10028-050-021002800500250 mL in 1 BOTTLE (10028-050-02) 50 ml2019-12-110000-00-00NoNoCurrent