Denorex Severe Itch

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: Denorex Severe Itch
Generic name: COAL TAR
Manufacturer: Neoteric Cosmetics, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 213ccbc4-2f52-58b6-e063-6294a90ae248
SPL ID: 213cb08a-41af-72f5-e063-6294a90a41f2
Version: 1
Effective date: 2024-09-03
Source export date: 2026-09-28
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:12:40

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 · 10 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M032	openfda.application_number
brand name		Denorex Severe Itch	openfda.brand_name
generic name		COAL TAR	openfda.generic_name
manufacturer name		Neoteric Cosmetics, Inc.	openfda.manufacturer_name
ndc	package	62673-175-10	openfda.package_ndc
ndc	product	62673-175	openfda.product_ndc
ndc11	package	62673017510	derived:openfda.package_ndc
spl id		213cb08a-41af-72f5-e063-6294a90a41f2	id
spl set id		213ccbc4-2f52-58b6-e063-6294a90ae248	set_id
unii		R533ESO2EC	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 Ask a doctor before use if you have a condition covers a large area of the body. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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