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 36 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADSSALICYLIC ACIDThe Mentholatum Companyc36f7012-6fc7-4141-8492-6a20d3cf48682024-12-13WarningsExact identifier
application number: M006
OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADSSALICYLIC ACIDThe Mentholatum Company99874117-b1f5-48bf-a1b1-3a2af9d9ae272024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Sensitive Skin Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4967f854-d1e4-4fb6-84c7-1293f5f906302024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4171b8a9-7ebf-4c02-a086-87038b6c68c42024-12-13WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Companye613e8a6-ffed-49bc-bdc0-87606c51ffa32024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company76fddd7e-8323-4046-8c90-2edafc3e09372024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Face ScrubSALICYLIC ACIDThe Mentholatum Companyb3213f88-9496-4c89-ab1b-225bd81891c22024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSERSALICYLIC ACIDThe Mentholatum Companyd2799f22-5684-4510-9141-073acf4b15342024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Company6c337b14-6779-4d98-b61b-c210b0fdd9262024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Companyd3baf470-9528-4a6d-b354-5ebe640b77742024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Clarifying MoisturizerBENZOYL PEROXIDEThe Mentholatum Company4568b5d1-efde-4b2f-b7cc-8d227d05dfa12024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Vitamin C SerumSALICYLIC ACIDThe Mentholatum Company29b34faa-7c74-4e79-ad47-1660a3e701a72024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Creamy Facial CleanserSALICYLIC ACIDThe Mentholatum Companyaed37bff-6723-4865-aa9b-10e7adcceeea2024-12-13WarningsExact identifier
application number: M006
OXY Sensitive Face Wash Maximum SoothingBENZOYL PEROXIDEThe Mentholatum Companyc02ff802-fe48-41fb-a9dd-6a74da334a522024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Daily Gel Face WashSALICYLIC ACIDThe Mentholatum Companyaccafe6b-d350-4539-a39d-a9ee9a4fee292024-12-13WarningsExact identifier
application number: M006
OXY 10 Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company35dbfe37-992d-4c9c-a4be-707d32370c762024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Body WashSALICYLIC ACIDThe Mentholatum Companye4c88ea1-5311-4e1f-a9ac-facef02b9c042024-12-13WarningsExact identifier
application number: M006
Stridex XL Face and Body PadsSALICYLIC ACIDBlistex Inced459e80-22cc-40ef-862c-1adf82da23772024-12-13WarningsExact identifier
application number: M006
Stridex EssentialSALICYLIC ACIDBlistex Inc994b890a-8a82-4ce2-a4a4-bde2360cc2592024-12-13WarningsExact identifier
application number: M006
Stridex SensitiveSALICYLIC ACIDBlistex Inc843d3424-bd6c-44aa-976b-63c9da15014e2024-12-12WarningsExact 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