Exelderm

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: Exelderm
Generic name: SULCONAZOLE NITRATE
Manufacturer: Journey Medical Corporation
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 5b73e83e-8d3c-4d96-b4f6-9f854430add8
SPL ID: 53b92932-d626-2d66-e063-6294a90a8f6a
Version: 4
Effective date: 2026-06-08
Source export date: 2026-10-12
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:59:03

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	018738	derived:openfda.application_number
application number		NDA018738	openfda.application_number
brand name		Exelderm	openfda.brand_name
generic name		SULCONAZOLE NITRATE	openfda.generic_name
manufacturer name		Journey Medical Corporation	openfda.manufacturer_name
ndc	package	69489-721-05	openfda.package_ndc
ndc	package	69489-721-30	openfda.package_ndc
ndc	product	69489-721	openfda.product_ndc
ndc11	package	69489072105	derived:openfda.package_ndc
ndc11	package	69489072130	derived:openfda.package_ndc
rxcui		313125	openfda.rxcui
rxcui		208118	openfda.rxcui
spl id		53b92932-d626-2d66-e063-6294a90a8f6a	id
spl set id		5b73e83e-8d3c-4d96-b4f6-9f854430add8	set_id
unii		1T89100D5U	openfda.unii

Adverse reactions cross-check#

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

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

adverse reactions

ADVERSE REACTIONS There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.

Reported adverse events (FAERS/openFDA)#

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