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: 1d822e06-f37e-4984-8365-efd4c4451478
SPL ID: f03361cb-005c-4d0c-bc27-033484f02624
Version: 2
Effective date: 2022-07-19
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:09:34

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application applno	NDA	018737	derived:openfda.application_number
application number		NDA018737	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	69489-711-60	openfda.package_ndc
ndc	product	69489-711	openfda.product_ndc
ndc11	package	69489071160	derived:openfda.package_ndc
rxcui		208117	openfda.rxcui
rxcui		106366	openfda.rxcui
spl id		f03361cb-005c-4d0c-bc27-033484f02624	id
spl set id		1d822e06-f37e-4984-8365-efd4c4451478	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 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.

Reported adverse events (FAERS/openFDA)#

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