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 48 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XtraCare Deep Cleaning AstringentSALICYLIC ACIDRejoice International20cb8584-8a31-40a8-8a47-d9fa8ec8abcf2024-02-28WarningsExact identifier
application number: M006
The INKEY List Beta Hydroxy Acid SerumSALICYLIC ACIDBrand Evangelists for Beauty Ltdd554920f-e33a-484b-bbd8-5137156163842024-02-26WarningsExact identifier
application number: M006
LBRI PURE n NATURAL KlearAwaySALICYLIC ACIDL'BRI Health & Beauty561d17fc-0bbf-4112-9820-7d151cce00982024-02-22WarningsExact identifier
application number: M006
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories5cf3da87-ed50-4791-8f71-1b572f3b8f432024-02-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
application number: M006
Clear Acne Face CleanserACNE FACE CLEANSERKamedis354e2f5b-021b-4683-abe3-7517faf6f7342024-02-07WarningsExact identifier
application number: M006
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
application number: M006
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company0a608bd9-029a-4194-9173-acdcc32056b72024-02-06WarningsExact identifier
application number: M006
CLEAR IMPROVEMENT ACNE CLEARING HYDRATING LTNSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a4bae1-bbbb-0bf3-e063-6294a90a4af62024-02-05WarningsExact identifier
application number: M006
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

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