FDA.reportPublic FDA data

ANTIFUNGAL MEDICATED BODY WASH

Product NDC
83004-012
11-digit product format
830040012
Labeler code
83004
Product ID
83004-012_2efe0156-5331-f3dc-e063-6394a90ae105
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
GEL
Route
TOPICAL
Labeler
Rida LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-06
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ANTIFUNGAL MEDICATED BODY WASH
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui2689792

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83004-012-01ANTIFUNGAL MEDICATED BODY WASH56 g in 1 BOTTLE, PLASTICGEL563
83004-012-02ANTIFUNGAL MEDICATED BODY WASH113 g in 1 BOTTLE, PLASTICGEL1133
83004-012-03ANTIFUNGAL MEDICATED BODY WASH226 g in 1 BOTTLE, PLASTICGEL2263
83004-012-04ANTIFUNGAL MEDICATED BODY WASH453 g in 1 PACKAGEGEL4533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-012ANTIFUNGAL MEDICATED BODY WASH (TOLNAFTATE) GEL [RIDA LLC]3Current NDC, 4 package rows20250227_e3ebce6f-88ca-4100-ac79-d300f44e4891.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2689792tolnaftate 1 % Medicated Liquid SoapPSNe3ebce6f-88ca-4100-ac79-d300f44e48913
2689792tolnaftate 10 MG/ML Medicated Liquid SoapSCDe3ebce6f-88ca-4100-ac79-d300f44e48913
2689792tolnaftate 1 % Medicated Liquid SoapSYe3ebce6f-88ca-4100-ac79-d300f44e48913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-012-018300400120156 g in 1 BOTTLE, PLASTIC (83004-012-01) 56 g2024-06-06NoNoCurrent
83004-012-0283004001202113 g in 1 BOTTLE, PLASTIC (83004-012-02) 113 g2024-06-06NoNoCurrent
83004-012-0383004001203226 g in 1 BOTTLE, PLASTIC (83004-012-03) 226 g2024-06-06NoNoCurrent
83004-012-0483004001204453 g in 1 PACKAGE (83004-012-04) 453 g2024-06-06NoNoCurrent