athletes foot

Generic: butenafine hydrochloride

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name athletes foot
Generic Name butenafine hydrochloride
Labeler topco associates llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

butenafine hydrochloride 10 mg/g

Manufacturer
TOPCO ASSOCIATES LLC

Identifiers & Regulatory

Product NDC 36800-049
Product ID 36800-049_39068ae7-6070-8978-e063-6294a90afd38
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA205181
Listing Expiration 2026-12-31
Marketing Start 2017-11-17

Pharmacologic Class

Classes
benzylamine antifungal [epc] benzylamines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800049
Hyphenated Format 36800-049

Supplemental Identifiers

RxCUI
1298448
UNII
R8XA2029ZI

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name athletes foot (source: ndc)
Generic Name butenafine hydrochloride (source: ndc)
Application Number ANDA205181 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE
source: ndc

Packages (1)

36800-049-01 1 TUBE in 1 CARTON (36800-049-01) / 12 g in 1 TUBE

Ingredients (1)

butenafine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Athletes Foot ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "39068ae7-6070-8978-e063-6294a90afd38", "openfda": {"unii": ["R8XA2029ZI"], "rxcui": ["1298448"], "spl_set_id": ["3e976ed8-2af8-4d1e-bda6-e2f672c7ec03"], "manufacturer_name": ["TOPCO ASSOCIATES LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-049-01)  / 12 g in 1 TUBE", "package_ndc": "36800-049-01", "marketing_start_date": "20171212"}], "brand_name": "Athletes Foot", "product_id": "36800-049_39068ae7-6070-8978-e063-6294a90afd38", "dosage_form": "CREAM", "pharm_class": ["Benzylamine Antifungal [EPC]", "Benzylamines [CS]"], "product_ndc": "36800-049", "generic_name": "Butenafine Hydrochloride", "labeler_name": "TOPCO ASSOCIATES LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Athletes Foot", "active_ingredients": [{"name": "BUTENAFINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "ANDA205181", "marketing_category": "ANDA", "marketing_start_date": "20171117", "listing_expiration_date": "20261231"}