FDA.reportPublic FDA data

Miconazole Nitrate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Miconazole Nitrate
Generic name
ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE
Manufacturer
Discount Drug Mart, Inc
Product type
HUMAN OTC DRUG
SPL set ID
37790bf8-6114-84b9-e063-6394a90ad58d
SPL ID
42536dcc-b1cc-fe45-e063-6394a90ae319
Version
2
Effective date
2025-10-29
Source export date
2026-08-08
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/e78f1fb32bf83ef6e9a19dc8cb100566f7817d0ac9ed04e609562ab8ed7ab1de/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:53:22
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.