FDA.reportPublic FDA data

Ultra Clear Treatment

Product NDC
10028-051
Requested package NDC
10028-051-01
11-digit product format
100280051
Labeler code
10028
Product ID
10028-051_40954e8b-253c-052d-e063-6294a90ad812
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
ULTRACEUTICALS PTY LIMITED
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ultra Clear Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103568Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99b18387-4ab9-4975-e053-2995a90ad6c4Available on FDA.report

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
10028-051-022023-09-01Ultra 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
10028-051-022023-07-28Ultra 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
10028-051-012023-01-30Ultra 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 1 of 55 · 1,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006
RFA BPO Acne Treatment 2.5%BENZOYL PEROXIDETopiderm, Inc.c5053e9e-7608-45d9-9b9b-9b93210eb9172026-07-27WarningsExact identifier
application number: M006
ACNO Solution ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltd4a267e44-03d9-471f-9708-a5c60ff690972026-07-24WarningsExact identifier
application number: M006
DERMFREE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c8a6e-b02d-3a87-e063-6294a90a14ff2026-07-23WarningsExact identifier
application number: M006
salicylic acidSALICYLIC ACIDChain Drug Marketing Association4dc96074-50a1-baa8-e063-6294a90a5aab2026-07-22Warnings, Adverse reactionsExact identifier
application number: M006
SYLVIRENE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a3751f8-2365-1b34-e063-6394a90acf742026-07-21WarningsExact identifier
application number: M006
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact 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