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 27 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Facial Cleansing WipesFACIAL CLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD36f7677a-ec73-e677-e063-6294a90ad4802025-06-07WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
application number: M006
VENROCKSALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.349ae621-c832-128c-e063-6294a90a284d2025-06-05WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONbc9fffbc-c176-4d89-b1c6-294a8439a9302025-06-05WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne AM TreatmentBENZOYL PEROXIDEKenvue Brands LLCd6e05b11-8c5f-490d-a5d8-116dcc895cb82025-06-04WarningsExact identifier
application number: M006
TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADSSALICYLIC ACIDThe Procter & Gamble Manufacturing Company36ada73d-cfc5-d4a4-e063-6294a90a7c732025-06-03WarningsExact identifier
application number: M006
Psoriasis Body WashCOLLOIDAL OATMEALRida LLC4b2bba1b-7e7b-4397-9eb4-d94c44b983142025-06-03WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.4058327e-2764-4df0-9d5d-7cda72d9ca412025-06-02WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd3640d29e-7e4c-b3be-e063-6394a90a0d9e2025-05-29WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC36412939-97bc-6cb1-e063-6294a90aef482025-05-29WarningsExact identifier
application number: M006
Tula Skincare Clear It Up Acne Clearing and Tone Correcting GelSALICYLIC ACIDThe Procter & Gamble Manufacturing Company364a96fb-67fe-eeb7-e063-6394a90aa60c2025-05-29WarningsExact identifier
application number: M006
Psoriasis Scalp TreatmentSALICYLIC ACIDRida LLC14ab77e7-86b0-49d3-8efa-8a80c5a24d742025-05-28WarningsExact identifier
application number: M006
Aveeno Positively Radiant Clear Complexion Foaming CleanserSALICYLIC ACIDKenvue Brands LLCec136786-9d46-a022-e053-2a95a90a07522025-05-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Body Acne Cleanser and ExfoliatorSALICYLIC ACIDKenvue Brands LLCdd13b492-5c82-a7d0-e053-2a95a90a62b32025-05-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Texture Daily CleanserSALICYLIC ACIDKenvue Brands LLCef2d9cd5-5c6c-4839-af5d-6bc21187b1322025-05-26WarningsExact identifier
application number: M006
NAELI Exfoliator AHA-BHA Face CleanserSALICYLIC ACIDALLI LLC16bf50c6-4a9d-4242-94a2-d2165b82e7ce2025-05-22WarningsExact identifier
application number: M006
First Aid Beauty Acne Clearing PadsSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35bd600b-5da6-5225-e063-6294a90ac6f32025-05-22WarningsExact identifier
application number: M006
First Aid Beauty Body Acne Clearing MistSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35be1450-01c1-1668-e063-6394a90af9b52025-05-22WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC353ed0a4-dcae-7748-e063-6294a90ac3f72025-05-16WarningsExact identifier
application number: M006
Dickinsons Original Witch Hazel Exfoliating Bubble TonerSALICYLIC ACIDDickinson Brands Inc.5a5119a2-d6ca-4932-9df6-faed97e1d2a12025-05-16WarningsExact 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