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 49 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeraVe Developed with Dermatologists Acne Control CleanserSALICYLIC ACIDL'Oreal USA Products Inc00203b2a-74dd-45a5-977a-3ef4eb3145772023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratorie Dermatologique Effaclar Medicated CleanserSALICYLIC ACIDL'Oreal USA Products Inc8a6e2634-2497-403a-af03-113bf35fe36a2023-12-31WarningsExact identifier
application number: M006
CeraVe Acne Foaming CleanserBENZOYL PEROXIDEL'Oreal USA Products Incd9c11b75-14ee-46e3-9b1d-c349a102e2fd2023-12-31WarningsExact identifier
application number: M006
La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne TreatmentBENZOYL PEROXIDEL'OREAL USA, INC.8ed6ee51-816e-4c83-a437-4ceaa339b1302023-12-31WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2532352e-eabc-4565-9437-b8801db6937a2023-12-31WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser Treatment with Frankincense and Ginger RootSALICYLIC ACIDL'Oreal USA Products Incd8ad899b-a4d9-4720-aa37-b35d95ff899c2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Targeted Acne Spot TreatmentSULFURL'Oreal USA Products Inc217c697e-0260-46d5-a202-ce7345eadd942023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Expertly Clear Acne Treating and PreventingSALICYLIC ACIDL'Oreal USA Products Inc14429a1d-7db9-49a7-85d6-22374d03ecaa2023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing SolutionSALICYLIC ACIDL'Oreal USA Products Inc55f614ee-f0fb-425d-aa5e-f90cad51c2852023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Blue Herbal Acne Cleanser TreatmentSALICYLIC ACIDL'Oreal USA Products Inc09e7f362-6187-4e49-b703-8249c70e51242023-12-30WarningsExact identifier
application number: M006
Kiehls Since 1851 Dermatologist Solutions Breakout Control Acne Treatment FacialSALICYLIC ACIDL'Oreal USA Products Inc3346f5f8-5793-47f6-8e71-250d3cc05c0d2023-12-30WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm SOS Acne Rescue Spot CorrectorSULFURL'Oreal USA Products Inc4907bc52-62e3-4256-b4ca-bcde896a4aab2023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula PadsSALICYLIC ACIDL'Oreal USA Products Incbc0d1691-c13d-4c15-8c44-ecee30cb0ae22023-12-27WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula CleanserSALICYLIC ACIDL'Oreal USA Products Inc935a58f0-d9a3-4423-9a5f-65fd19fad3db2023-12-27WarningsExact identifier
application number: M006
All Acne TreatmentSALICYLIC ACIDBlaine Labs Inc.ee85939e-64fc-4b18-af5b-6ebd7e14e5722023-12-21WarningsExact identifier
application number: M006
In the Clear Acne SerumSALICYLIC ACIDThe Honest Company, Incdc9e0545-43af-3d27-e053-2a95a90a52492023-12-19WarningsExact identifier
application number: M006
Spot Stopper Acne Spot TreatmentSALICYLIC ACIDThe Honest Company, Incdc7afebd-e212-b9ff-e053-2a95a90a15a52023-12-19WarningsExact identifier
application number: M006
Get Clarity Foaming Acne CleanserSULFURThe Honest Company, Incdd948b1b-d71c-1a89-e053-2a95a90a87192023-12-19WarningsExact identifier
application number: M006
Acne Med 10%BENZOYL PEROXIDEFace Reality, LLC45ad7429-ccd0-28f6-e054-00144ff88e882023-12-15WarningsExact identifier
application number: M006
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact 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