FDA.reportPublic FDA data

Clear Acne Spot Treatment

Product NDC
50718-0032
11-digit product format
507180032
Labeler code
50718
Product ID
50718-0032_d8bfce91-7eeb-4696-ae5f-b4fa7514f928
Type
HUMAN OTC DRUG
Nonproprietary name
Acne Spot Treatment
Dosage form
LIQUID
Route
TOPICAL
Labeler
Kamedis
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
SALICYLIC ACID
Active strength
28.8 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID28.8 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50718-0032-12024-02-12C16284748780-11030e365-6eee-111a-e063-dadaa90a10e2Clear Acne Spot Treatment
50718-0032-12024-01-30C16284748780-11030e365-6eee-111a-e063-dadaa90a10e2Clear Acne Spot Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50718-0032-1Clear Acne Spot Treatment1 in 1 CARTONLIQUID15
50718-0032-1Clear Acne Spot Treatment22 mL in 1 BOTTLELIQUID225
50718-0032-1Clear Acne Kit1 in 1 CARTONLIQUID28.8 mg in 1mL2
50718-0032-1Clear Acne Kit22 mL in 1 BOTTLELIQUID22 mL28.8 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50718-0032CLEAR ACNE SPOT TREATMENT (ACNE SPOT TREATMENT) LIQUID [KAMEDIS]5Current NDC, Legacy NDC, 2 package rows20240214_00764a10-f1fe-45f5-89b4-9e891a221004.zip
50718-0032CLEAR ACNE KIT (ACNE KIT) KIT [KAMEDIS]2Current NDC, Legacy NDC20200708_de311f9e-a8e6-4a3e-ada0-b3882bb67b6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2200082{1 (22 ML) (salicylic acid 0.02 MG/MG Topical Gel) / 1 (100 ML) (salicylic acid 10 MG/ML Medicated Liquid Soap) / 1 (50 ML) (salicylic acid 20 MG/ML Topical Lotion) } PackGPCKde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
1038982salicylic acid 1 % Medicated Liquid SoapPSNde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
2200082salicylic acid 1 % Medicated Liquid Soap (100 ML) / salicylic acid 2 % Topical Lotion (50 ML) / salicylic acid 2 % Topical Gel (22 ML) PackPSNde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
346298salicylic acid 2 % Topical GelPSNde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
103568salicylic acid 2 % Topical LotionPSNde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
346298salicylic acid 0.02 MG/MG Topical GelSCDde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCDde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
103568salicylic acid 20 MG/ML Topical LotionSCDde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
1038982salicylic acid 1 % Medicated Liquid SoapSYde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
2200082salicylic acid 1 % Medicated Liquid Soap (100 ML) / salicylic acid 2 % Topical Lotion (50 ML) / salicylic acid 2 % Topical Gel (22 ML) PackSYde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
346298salicylic acid 2 % Topical GelSYde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2
103568salicylic acid 2 % Topical LotionSYde311f9e-a8e6-4a3e-ada0-b3882bb67b6c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50718-0032-1507180032011 BOTTLE in 1 CARTON (50718-0032-1) / 22 mL in 1 BOTTLE1 bottle2018-01-010000-00-00NoNoCurrent