Home NDC 11523-0158 Lotrimin Ultra
Product NDC 11523-0158
11-digit product format 115230158
Labeler code 11523
Product ID 11523-0158_4526df19-7a72-0f19-e063-6394a90a3954
Type HUMAN OTC DRUG
Nonproprietary name Butenafine hydrochloride
Dosage form CREAM
Route TOPICAL
Labeler Bayer Healthcare LLC.
Application NDA021307
Marketing category NDA
Marketing start 2024-01-02
Substance BUTENAFINE HYDROCHLORIDE
Active strength 1 g/100g
Pharmacologic classes Benzylamine Antifungal [EPC], Benzylamines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021307-001 LOTRIMIN ULTRA BUTENAFINE HYDROCHLORIDE 1% CREAM / TOPICAL RLD, RS 2001-12-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021307-001 LOTRIMIN ULTRA 1% CREAM / TOPICAL RLD, RS 2001-12-07 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lotrimin Ultra
Brand name suffix Ringworm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BUTENAFINE HYDROCHLORIDE 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R8XA2029ZI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298448 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11523-0158-2 Lotrimin UltraRingworm 1 in 1 CARTON CREAM 1 3 11523-0158-2 Lotrimin UltraRingworm 30 g in 1 TUBE CREAM 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11523-0158 LOTRIMIN ULTRA RINGWORM (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.] 2 Current NDC, 2 package rows 20240704_1b438ca7-fd5f-62cb-e063-6294a90ab3a6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11523-0158-2 11523015802 1 TUBE in 1 CARTON (11523-0158-2) / 30 g in 1 TUBE 1 tube 2024-07-31 No No Current