Home NDC 56104-121-01 Miconazole Nitrate
Product NDC 56104-121
Requested package NDC 56104-121-01
11-digit product format 561040121
Labeler code 56104
Product ID 56104-121_29b6fb49-f5fd-d406-e063-6294a90ace19
Type HUMAN OTC DRUG
Nonproprietary name Antifungal Miconazole Powder Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Premier Brands of America Inc.
Application M005
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-12
Substance MICONAZOLE NITRATE
Active strength 2.6 g/130g
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Miconazole Nitrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MICONAZOLE NITRATE 2.6 g/130g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998428 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 56104-121-01 Miconazole Nitrate 130 g in 1 CANISTER AEROSOL, SPRAY 130 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56104-121 MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE POWDER SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.] 4 Current NDC, Legacy NDC, 1 package rows 20250227_dc7a23bb-b246-89b1-e053-2995a90a9f2d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 8 of 49 · 973 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56104-121-01 56104012101 130 g in 1 CANISTER (56104-121-01) 130 g 2022-04-12 0000-00-00 No No Current