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 26 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acne buster star patch 140 patches - Tea Tree Extract and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.a94c69ee-70e9-448b-aa8a-556fcbd638852025-08-01WarningsExact identifier
application number: M006
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC098e0fcf-7640-e40a-e063-6394a90ac1ee2025-07-28WarningsExact identifier
application number: M006
Clean and Clear Acne Exfoliating CleanserSALICYLIC ACIDKenvue Brands LLC09a07037-4085-ee0a-e063-6394a90aa7142025-07-28WarningsExact identifier
application number: M006
The Inkey List 360 Acne Clearing SerumSALICYLIC ACIDBrand Evangelists for Beauty Limitede5c0e866-4dd8-43d0-abaf-2e2351eb57c72025-07-25WarningsExact identifier
application number: M006
RoyceDerm Sulfur Soap.SULFURRoyceDerm LLC3a323a77-eff4-973f-e063-6394a90a02a02025-07-18WarningsExact identifier
application number: M006
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incfd92c669-997e-4eea-b883-fe3486b83f312025-07-15WarningsExact identifier
application number: M006
Blemish Blitz Emergency Acne SerumSALICYLIC ACIDGuangdong Joyan Biological Technology Co.,Ltd397a910a-c0ca-f5cb-e063-6394a90a3b9e2025-07-09WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Medication CleanserBENZOYL PEROXIDEL'Oreal USA Products Inccf49ed9b-8c1d-49f9-8c77-bb6a5abce9e42025-07-09WarningsExact identifier
application number: M006
La Roche Posay Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc4795cc87-c663-4702-b65d-ce85203f12582025-07-08WarningsExact identifier
application number: M006
Neutrogena Clear Pore Cleanser MaskBENZOYL PEROXIDEKenvue Brands LLCd020adb5-7f87-42c0-939d-99eb8744f65e2025-07-07WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC06804b81-db22-12ec-e063-6294a90a28e12025-07-07WarningsExact identifier
application number: M006
CeraVe Acne Clay-to-Foam CleanserSALICYLIC ACIDLOreal USA Products Inc3c4c2f52-0d37-4a3b-9a8d-2d54574b58d22025-06-26WarningsExact identifier
application number: M006
Freshiny Facial Cleanser Acne TreatmentSALICYLIC ACIDGuangdong Bawei Biotechnology Corporation4afe3a7e-8119-432a-b56a-34664d9b5a122025-06-24WarningsExact identifier
application number: M006
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
application number: M006
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
application number: M006
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
application number: M006
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
application number: M006
Margarite Zinc CreamZINC CREAMRenu Laboratories, LLC3ca3b7d8-702a-036b-e054-00144ff8d46c2025-06-10WarningsExact 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