FDA label 338a78d2-c23d-0fac-e063-6394a90ab9c4

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)

SPL set ID: 23fa7cb0-590f-2037-e063-6394a90ab7a0
SPL ID: 338a78d2-c23d-0fac-e063-6394a90ab9c4
Version: 2
Effective date: 2025-04-24
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 06:25:39

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 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		338a78d2-c23d-0fac-e063-6394a90ab9c4	id
spl set id		23fa7cb0-590f-2037-e063-6394a90ab7a0	set_id

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. Not for ophthalmic use. PRECAUTIONS: Allergic Reactions: Hypersensitivity reactions, including severe allergic contact dermatitis and anaphylactic reactions, have been reported with Miconazole use. Discontinue use immediately if signs of hypersensitivity occur. USE IN PREGNANCY: Category C: There are no adequate and well-controlled studies of Miconazole Nitrate or DMSO use in pregnant women. It should be used during pregnancy only if clearly needed.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: The most common side effects reported during the use of Miconazole-containing products are local irritation, burning, stinging, redness, or swelling at the application site.

Reported adverse events (FAERS/openFDA)#

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