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 29 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clarifying CleanserSALICYLIC ACIDMurad, LLC9c9e66fb-9212-4e61-b7ba-c31cfa91d3c92025-03-28WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing TechnologySALICYLIC ACIDL'Oreal USA Products Inc7b622b57-21be-4870-a2fe-11447a9e321a2025-03-28WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDMurad, LLC8297fbbe-ea3f-40bc-8dd8-319de45b30242025-03-28WarningsExact identifier
application number: M006
Kiehls Gently Effective Acne Treating CleansingSALICYLIC ACIDL'Oreal USA Products Incb6894aae-c131-4e4a-a035-f7c20f6bc5052025-03-28WarningsExact identifier
application number: M006
TKTXTKTXCOMMERCE OPERATIONS LLC2f867e2b-df7d-c34a-e063-6294a90a17242025-03-25WarningsExact identifier
application number: M006
Neutrogena Body Clear Body ScrubSALICYLIC ACIDKenvue Brands LLC8dbd1942-f644-446b-9292-8fc44fb165a22025-03-20WarningsExact identifier
application number: M006
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd27b3b2cf-83f6-78fb-e063-6394a90a41f42025-03-18WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Sensitive Skin Facial Cleanser Fragrance FreeSALICYLIC ACIDKenvue Brands LLC1a439f48-22f1-73fa-e063-6294a90a3f8e2025-03-18WarningsExact identifier
application number: M006
SOS Rituals Pore Pop Fizz Mask Blackhead TreatmentSALICYLIC ACIDI World LLC692a7c40-7b55-4e53-9e06-60052d96f4cb2025-03-17WarningsExact identifier
application number: M006
GOODBYE ACNE THERAPEUTIC SULFUR MASKSULFURPETER THOMAS ROTH, LLC308ec305-dbf3-c6f9-e063-6294a90a14ec2025-03-17WarningsExact identifier
application number: M006
SOS Rituals Bacne AwaySALICYLIC ACIDI World LLCd79c491f-6123-49fb-a92e-dab684f6eef42025-03-14WarningsExact identifier
application number: M006
SOS Rituals Glow Away Blemish Spot TreatmentSALICYLIC ACIDI World LLC621ecd53-275b-4530-8b34-7cbc5817f77b2025-03-14WarningsExact identifier
application number: M006
SulfurCLARIFYING DETOX (ACNE TREATMENT) MASKVege Labs LLC303cea30-0502-0cb8-e063-6394a90ac9ed2025-03-13WarningsExact identifier
application number: M006
The INKEY List Salicylic Acid CleanserSALICYLIC ACIDBrand Evangelists for Beauty Ltd1ff0b8b4-f2de-477b-99f5-844ee8f6e5b22025-03-07WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC6b2e27a6-961f-4f5c-a834-fcbd23460e682025-03-05WarningsExact identifier
application number: M006
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC39a6cf99-41c8-4412-8df1-70071fd205af2025-03-05WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb5f856d6-5403-4a88-8d64-764ab9abf7d32025-02-28WarningsExact identifier
application number: M006
Pore Refining TonerSALICYLIC ACIDPrivate Label Skin Care93db4294-3422-478e-a82e-122b39cac2882025-02-27WarningsExact identifier
application number: M006
SUNDAY RILEY PEACEKEEPER ACNE TREATMENT SERUMSALICYLIC ACIDSunday Riley Modern Skincare, LLC811271e4-afe4-4dea-8137-7b1fe4397a5a2025-02-27WarningsExact 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