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: MICONAZOLE NITRATE
Manufacturer: STRATEGIC SOURCING SERVICES LLC
Product type: HUMAN OTC DRUG
SPL set ID: 966a1000-3b08-4f2c-a9f8-568f2524b717
SPL ID: 39fae2a4-9033-3c88-e063-6394a90acbd5
Version: 3
Effective date: 2025-07-15
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:29:32

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		Miconazole Nitrate	openfda.brand_name
generic name		MICONAZOLE NITRATE	openfda.generic_name
manufacturer name		STRATEGIC SOURCING SERVICES LLC	openfda.manufacturer_name
ndc	package	70677-1000-1	openfda.package_ndc
ndc	product	70677-1000	openfda.product_ndc
ndc11	package	70677100001	derived:openfda.package_ndc
rxcui		998483	openfda.rxcui
spl id		39fae2a4-9033-3c88-e063-6394a90acbd5	id
spl set id		966a1000-3b08-4f2c-a9f8-568f2524b717	set_id
unii		VW4H1CYW1K	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Do not use on children less than 2 years of age unless directed by a doctor When using this product avoid contact with the eyes Stop use and ask a doctor if irritation occurs condition persists there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.