Proctozone-G

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: Proctozone-G
Generic name: GLYCERIN
Manufacturer: Rising Pharma Holdings, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 8a5c8ad5-3619-4971-967d-165270a20bc8
SPL ID: 553c8839-ee7f-4b94-986f-69ddfbf085c5
Version: 2
Effective date: 2026-01-06
Source export date: 2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:27:45

Harmonized routes table
Harmonized routes
RECTAL

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 · 17 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M007.54	openfda.application_number
brand name		Proctozone-G	openfda.brand_name
generic name		GLYCERIN	openfda.generic_name
manufacturer name		Rising Pharma Holdings, Inc.	openfda.manufacturer_name
ndc	package	57237-338-51	openfda.package_ndc
ndc	package	57237-338-52	openfda.package_ndc
ndc	package	57237-338-21	openfda.package_ndc
ndc	package	57237-338-16	openfda.package_ndc
ndc	product	57237-338	openfda.product_ndc
ndc11	package	57237033852	derived:openfda.package_ndc
ndc11	package	57237033816	derived:openfda.package_ndc
ndc11	package	57237033821	derived:openfda.package_ndc
ndc11	package	57237033851	derived:openfda.package_ndc
rxcui		421299	openfda.rxcui
spl id		553c8839-ee7f-4b94-986f-69ddfbf085c5	id
spl set id		8a5c8ad5-3619-4971-967d-165270a20bc8	set_id
unii		PDC6A3C0OX	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 rectal use only Do not use for longer than 1 week unless directed by a doctor. Ask a doctor before use if the child has Stomach pain, nausea or vomiting A sudden change in bowel habits lasting more than 2 weeks When using this product your child may have rectal discomfort or a burning sensation Stop use and ask a doctor if you have Rectal bleeding No bowel movement after using this product These may indicate a serious condition. 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.