Athletes Foot

Product NDC
36800-049
11-digit product format
368000049
Labeler code
36800
Product ID
36800-049_39068ae7-6070-8978-e063-6294a90afd38
Type
HUMAN OTC DRUG
Nonproprietary name
Butenafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
TOPCO ASSOCIATES LLC
Application
ANDA205181
Marketing category
ANDA
Marketing start
2017-11-17
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Benzylamine Antifungal [EPC], Benzylamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Athletes Foot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTENAFINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8XA2029ZI
Rxcui1298448

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-049-01Athletes Foot12 g in 1 TUBECREAM123
36800-049-01Athletes Foot1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-049ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 2 package rows20180821_3e976ed8-2af8-4d1e-bda6-e2f672c7ec03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298448butenafine HCl 1 % Topical CreamPSN3e976ed8-2af8-4d1e-bda6-e2f672c7ec033
1298448butenafine hydrochloride 10 MG/ML Topical CreamSCD3e976ed8-2af8-4d1e-bda6-e2f672c7ec033
1298448butenafine HCl 1 % Topical CreamSY3e976ed8-2af8-4d1e-bda6-e2f672c7ec033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-049-01368000049011 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE1 tube2017-12-120000-00-00NoNoCurrent