Ultra Clear Treatment

Product NDC
10028-051
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 Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ
Rxcui103568

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10028-051-012023-09-01C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-09-01C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-09-01C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-09-01C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-07-28C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-07-28C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-07-28C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-022023-07-28C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-02-17C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-02-17C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-01-30C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra Clear Treatment Lotion with salicylic and mandelic acid
10028-051-012023-01-30C16284748780-1f386c64a-261e-0266-e053-dadaa90a7c1aUltra 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

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