FDA.reportPublic FDA data

Ultra Clear Treatment

Product NDC
10028-051
11-digit product format
100280051
Labeler code
10028
Product ID
10028-051_5d487215-f5cb-e771-e063-6294a90a1baf
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
2019-12-15
Substance
SALICYLIC ACID
Active strength
2 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 Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
10028-051-012023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-09-01Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-07-28Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-02-17Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-02-17Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-02-17Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-01-30Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-01-30Ultra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-01-30Ultra Clear Treatment Lotion with salicylic and mandelic acid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10028-051-01Ultra Clear Treatment50 mL in 1 BOTTLELOTION507
10028-051-02Ultra Clear Treatment30 mL in 1 BOTTLELOTION307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10028-051ULTRA CLEAR TREATMENT (SALICYLIC ACID) LOTION [ULTRACEUTICALS PTY LIMITED]6Current NDC, Legacy NDC, 2 package rows20241025_99b18387-4ab9-4975-e053-2995a90ad6c4.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 40 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DoveACNE CLEAR BODY CLEANSERCONOPCO Inc. d/b/a Unilevere441828a-9511-0dbf-e053-2a95a90a4beb2024-11-07WarningsExact identifier
application number: M006
AxeACNE CONTROL BODY HAND AND FACE BARConopco Inc. d/b/a/ Unileverddcfb8de-f45c-46e1-e053-2a95a90a28452024-11-07WarningsExact identifier
application number: M006
St. Ives Blemish and Blackhead Control Apricot ScrubSOLUTIONS ACNE CONTROL SPOT TREATMENTCONOPCO Inc. d/b/a Unileverbcb7774a-b51b-34f6-e053-2995a90a22872024-11-07WarningsExact identifier
application number: M006
St. Ives Blemish and Blackhead Control Apricot ScrubSOLUTIONS ACNE CONTROL TEA TREE CLEANSERCONOPCO Inc. d/b/a Unileverbc7d7bbf-eff4-e558-e053-2995a90ab8082024-11-07WarningsExact identifier
application number: M006
Meijer Foaming Cleanser Acne medicationSALICYLIC ACIDMeijer Distribution, Inc58831561-68c0-4b1d-82f3-7944f948c03d2024-11-07WarningsExact identifier
application number: M006
Meijer Clarifying Body Wash Acne TreatmentSALICYLIC ACIDMeijer Distribution, Inc5424ef68-919a-4f29-99f4-db9972d0e6ab2024-11-07WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutions98e1bf69-ef71-4e38-8357-54c60d9d03df2024-11-06WarningsExact identifier
application number: M006
Clean and Clear acne triple clear exfoliating scrubSALICYLIC ACIDKenvue Brands LLCfb15d9b4-386f-4be5-b39b-8e95c982dce72024-11-06WarningsExact identifier
application number: M006
Clean and Clear Advantage Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLCb907a42d-14ff-4ea1-b197-28f8340c9ed22024-11-06WarningsExact identifier
application number: M006
Clean and Clear Persa-Gel 10BENZOYL PEROXIDEKenvue Brands LLCec5d1347-bee9-4dbd-9778-ff7519b600412024-11-06WarningsExact identifier
application number: M006
Clean and Clear Essentials Deep Cleaning AstringentSALICYLIC ACIDKenvue Brands LLC0beeddf8-8fd5-4ea1-a181-b07c360ddcd32024-11-06WarningsExact identifier
application number: M006
Avene Cleanance Acne Medicated Clearing Gel CleanserSALICYLIC ACIDPierre Fabre USA Inc.faa8e2b6-5204-5f1a-e053-6294a90a65f72024-11-06WarningsExact identifier
application number: M006
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
application number: M006
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
application number: M006
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
application number: M006
Aveeno CLEAR COMPLEXION foaming cleanserSALICYLIC ACIDKenvue Brands LLC32425c63-7ed9-401b-a271-988b52b4f1052024-11-05WarningsExact identifier
application number: M006
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
application number: M006
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103568salicylic acid 2 % Topical LotionPSN99b18387-4ab9-4975-e053-2995a90ad6c47
103568salicylic acid 20 MG/ML Topical LotionSCD99b18387-4ab9-4975-e053-2995a90ad6c47
103568salicylic acid 2 % Topical LotionSY99b18387-4ab9-4975-e053-2995a90ad6c47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10028-051-011002800510150 mL in 1 BOTTLE (10028-051-01) 50 ml2019-12-150000-00-00NoNoCurrent
10028-051-021002800510230 mL in 1 BOTTLE (10028-051-02) 30 ml2023-03-09NoNoCurrent