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 49 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLEAR IMPROVEMENT BLACKHEAD CLEARING MASK TO SCRUBSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a54180-5ad9-d4af-e063-6394a90a26f92024-02-05WarningsExact identifier
application number: M006
OXY Rapid Spot Treatment Maximum ActionBENZOYL PEROXIDEThe Mentholatum Company226dad56-e415-41ec-937a-4282c73f0d342024-01-23WarningsExact identifier
application number: M006
Caring mill Acne TreatmentBENZOYL PEROXIDEFSA Store Inc.0ec20ba4-9251-fbb3-e063-6394a90a2ad62024-01-12WarningsExact identifier
application number: M006
CeraVe Acne Foaming CreamWashBENZOYL PEROXIDEL'Oreal USA Products Inc06950d35-daa8-4ea3-bd33-6e9c162e2a632024-01-09WarningsExact identifier
application number: M006
Peace Out Acne Day and Night DuoSALICYLIC ACIDPeace Out LLC.ecacd6ab-a5ce-a516-e053-2995a90a44142024-01-03WarningsExact identifier
application number: M006
Peace Out Acne Day and Night DuoSALICYLIC ACIDPeace Out LLC.ecbf7dec-fc5a-156a-e053-2995a90af0852024-01-03WarningsExact identifier
application number: M006
Garnier Clean Blackhead Eliminating ScrubSALICYLIC ACIDL'Oreal USA Products Inccb389547-ad1d-4c51-8c2e-bf3fc58972822024-01-02WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar ClarifyingSALICYLIC ACIDL'Oreal USA Products Incdebff755-c83d-42c0-80fc-be73952eceb42024-01-01WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Gentle CleanserSALICYLIC ACIDL'Oreal USA Products Incb34515cb-0495-4f70-be40-508df29902862024-01-01WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control CleanserSALICYLIC ACIDL'Oreal USA Products Inc00203b2a-74dd-45a5-977a-3ef4eb3145772023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratorie Dermatologique Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc8a6e2634-2497-403a-af03-113bf35fe36a2023-12-31WarningsExact identifier
application number: M006
CeraVe Acne Foaming CleanserBENZOYL PEROXIDEL'Oreal USA Products Incd9c11b75-14ee-46e3-9b1d-c349a102e2fd2023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne TreatmentBENZOYL PEROXIDEL'OREAL USA, INC.8ed6ee51-816e-4c83-a437-4ceaa339b1302023-12-31WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2532352e-eabc-4565-9437-b8801db6937a2023-12-31WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment with Frankincense and Ginger RootSALICYLIC ACIDL'Oreal USA Products Incd8ad899b-a4d9-4720-aa37-b35d95ff899c2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot TreatmentSULFURL'Oreal USA Products Inc217c697e-0260-46d5-a202-ce7345eadd942023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and PreventingSALICYLIC ACIDL'Oreal USA Products Inc14429a1d-7db9-49a7-85d6-22374d03ecaa2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing SolutionSALICYLIC ACIDL'Oreal USA Products Inc55f614ee-f0fb-425d-aa5e-f90cad51c2852023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser TreatmentSALICYLIC ACIDL'Oreal USA Products Inc09e7f362-6187-4e49-b703-8249c70e51242023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment FacialSALICYLIC ACIDL'Oreal USA Products Inc3346f5f8-5793-47f6-8e71-250d3cc05c0d2023-12-30WarningsExact 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