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 34 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHBentley Laboratories, LLCeb7fa2b5-3bdb-436c-8576-1eea29b8d1ff2024-12-27WarningsExact identifier
application number: M006
Acne Control Superclean Body Wash AHA BHA FormulaSALICYLIC ACIDBentley Laboratories, LLC16fd3343-d044-4f6b-af1a-30bc32ce20412024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Blemish Plus Age Defense Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc5726d12c-708c-46e6-a584-9e5c7a544fc82024-12-27WarningsExact identifier
application number: M006
SkinCeuticals Clarifying Exfoliating CleanserSALICYLIC ACIDL'Oreal USA Products Inca0cc4ae7-c266-4321-92e6-a46d560a74b22024-12-27WarningsExact identifier
application number: M006
BRODA AcneSALICYLIC ACIDBentley Laboratories, LLCb7e1f105-8998-46a5-b1ae-85d21790b8162024-12-27WarningsExact identifier
application number: M006
Monat Be Clarified Acne-Clearing MoisturizerSALICYLIC ACIDCosmax Usa, Corporation2984d615-7ed1-46c3-e063-6294a90a1f8a2024-12-26WarningsExact identifier
application number: M006
Nativae Milia Acne SerumSALICYLIC ACIDCDE BRANDS LLCe04cf0a2-bda7-4e5b-9771-769995cf69252024-12-26WarningsExact identifier
application number: M006
Milani Erase Base Blemish Control PrimerSALICYLIC ACIDCosmax Usa, Corporation1b1f1948-2ad9-48d2-9871-6830b2442f432024-12-26WarningsExact identifier
application number: M006
Oxy Sensitive Skin Acne Cleansing PadsSALICYLIC ACID 0.5%The Mentholatum Company2a36b6c5-f518-66f0-e063-6394a90acd402024-12-26WarningsExact identifier
application number: M006
Oxy Deep Pore Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a385fac-399b-c111-e063-6394a90aefc32024-12-26WarningsExact identifier
application number: M006
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACID 2%The Mentholatum Company2a398c8d-09e6-513b-e063-6294a90ad8572024-12-26WarningsExact identifier
application number: M006
DEEP ACNESULFURDermalogica, LLC.d4e9d230-2ee4-4cc7-a7c9-a7dde50b6f402024-12-26WarningsExact identifier
application number: M006
SUNDAY RILEY SATURN SULFUR ACNE SPOT TREATMENT MASKSULFURSunday Riley Modern Skincare, LLC35364a71-b011-42f5-9941-4a2f8440808b2024-12-26WarningsExact identifier
application number: M006
Breakout Clearing Foaming WashSALICYLIC ACIDDermalogicae55d212b-7687-47fd-86ec-f8709804dd042024-12-24WarningsExact identifier
application number: M006
BREAKOUT CLEARING BOOSTERSALICYLIC ACIDDermalogica, Inc.6a3bb679-8a03-4f0a-950e-5a40f2b5b70e2024-12-24WarningsExact identifier
application number: M006
AGE Bright Clearing SerumSALICYLIC ACIDDermalogica, Incd5291f67-3329-42c7-b9c2-9bae797ecb5b2024-12-24WarningsExact identifier
application number: M006
Maybelline Dream Pure BB Beauty BalmSALICYLIC ACIDL'Oreal USA Products Inc553bea8f-92cd-416c-8bc1-39e4ec9cfcb42024-12-23WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Blemish Clearing CleanserSALICYLIC ACIDLOreal USA Products Inc4e03b29c-6d1c-473c-91b9-291a0cb523fb2024-12-23WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial AstringentSALICYLIC ACID 2%Derma Care Research Labs, LLCd692e7e2-11c7-7b4a-e053-2a95a90ae17b2024-12-20WarningsExact identifier
application number: M006
Dr Throwers Oily Skin Facial CleanserSALICYLIC ACID 2%Derma Care Research Labs, LLCd6e59f75-cd3d-3fc4-e053-2a95a90abf4c2024-12-20WarningsExact 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