Calmoseptine

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: Calmoseptine
Generic name: ANORECTAL OINTMENT
Manufacturer: Calmoseptine Inc.
Product type: HUMAN OTC DRUG
SPL set ID: ff9539ed-d9ae-401d-adbc-df8f1d751431
SPL ID: 2ba19ed3-445d-e95a-e063-6394a90abb3f
Version: 14
Effective date: 2025-01-13
Source export date: 2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:24

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 · 23 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Calmoseptine	openfda.brand_name
generic name		ANORECTAL OINTMENT	openfda.generic_name
manufacturer name		Calmoseptine Inc.	openfda.manufacturer_name
ndc	package	0799-0001-04	openfda.package_ndc
ndc	package	0799-0001-05	openfda.package_ndc
ndc	package	0799-0001-03	openfda.package_ndc
ndc	package	0799-0001-02	openfda.package_ndc
ndc	package	0799-0001-06	openfda.package_ndc
ndc	product	0799-0001	openfda.product_ndc
ndc11	package	00799000104	derived:openfda.package_ndc
ndc11	package	00799000106	derived:openfda.package_ndc
ndc11	package	00799000103	derived:openfda.package_ndc
ndc11	package	00799000102	derived:openfda.package_ndc
ndc11	package	00799000105	derived:openfda.package_ndc
rxcui		1946476	openfda.rxcui
rxcui		1946481	openfda.rxcui
spl id		2ba19ed3-445d-e95a-e063-6394a90abb3f	id
spl set id		ff9539ed-d9ae-401d-adbc-df8f1d751431	set_id
unii		7EV65EAW6H	openfda.unii
unii		4T6H12BN9U	openfda.unii
unii		L7T10EIP3A	openfda.unii
unii		SOI2LOH54Z	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 When using this product * Certain persons can develop allergic reactions to ingredients in this product. * Do not put this product into the rectum by using fingers or any mechanical device or applicator. * Do not exceed the recommended daily dosage unless directed by a doctor. * Avoid contact with eyes.

Reported adverse events (FAERS/openFDA)#

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