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 41 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
application number: M006
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medicationSALICYLIC ACIDMeijer Distribution, Inc3232b833-225f-429f-910c-d11874f3f1d52024-11-05WarningsExact identifier
application number: M006
SkinMedica Acne Clarifying TreatmentSALICYLIC ACIDAllergan, Inc.664d4733-e72d-410a-8ed0-a159d9dfa2362024-11-01WarningsExact identifier
application number: M006
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
application number: M006
Walgreens Acne Foaming Wash Acne MedicationBENZOYL PEROXIDEWalgreen Companyf34affe9-d470-48a5-b0d1-d62b9c44b3f22024-10-31WarningsExact identifier
application number: M006
Clearing Skin WashSALICYLIC ACIDDermalogica, LLC.5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf2024-10-30WarningsExact identifier
application number: M006
Walgreens Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEWalgreen Company5b6fab38-4a9e-4c5c-967e-e3a0ff03b6062024-10-30WarningsExact identifier
application number: M006
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9702add4-ea36-4c6b-9402-87b44f989a802024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd7441981a-654d-4f18-be21-66c863ee6d6f2024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f2024-10-23WarningsExact identifier
application number: M006
CVS Health Advanced Acne Spot TreatmentSALICYLIC ACIDCVS PHARMACYd4f1c74f-ee26-0e43-e053-2995a90a29722024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Rescue Skin-Clearing Loose Foundation Fair 1CSALICYLIC ACIDOrveon Global US LLC139e2d26-76de-4ad3-a6e6-7465bf5987ad2024-10-22WarningsExact identifier
application number: M006
bareMinerals Blemish Remedy Acne Treatment Gelee CleanserSALICYLIC ACIDOrveon Global US LLCb3060c4a-8f6f-4dea-a16c-fdc169ca4d112024-10-22WarningsExact identifier
application number: M006
RETINOID CLEARINGSALICYLIC ACIDDermalogica, LLC.fa77fdf4-873e-424e-8d89-05585615b1f42024-10-21WarningsExact identifier
application number: M006
La Roche Posay Effaclar Dermatological Acne System 3 Step Acne RoutineBENZOYL PEROXIDE AND SALICYLIC ACIDL'Oreal USA Products Incfa21d384-6867-442f-8537-290a691e25202024-10-21WarningsExact identifier
application number: M006
ACNE WASHSALICYLIC ACIDHarmon Stores Inc.9d0451a5-c8f9-4d0f-9928-fbc90ef134fe2024-10-21WarningsExact identifier
application number: M006
Peace Out Acne Day DotSALICYLIC ACIDPeace Out LLC.ec1a2ee4-f92b-b363-e053-2a95a90a5ccc2024-10-18WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.3744aef3-d92e-46a6-8c89-0fe5f0791a682024-10-18WarningsExact identifier
application number: M006
CVS Health Concealing Acne Treatment Maximum Strength Adult Acne TreatmentBENZOYL PEROXIDECVS PHARMACYfa402202-1750-e6eb-e053-6294a90a4e632024-10-17WarningsExact 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