GRANULOTION Hemorrhoidal

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: GRANULOTION Hemorrhoidal
Generic name: MENTHOL, ZINC OXIDE
Manufacturer: GL Health, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 1a32741c-5e4a-40e5-b15a-8233c5bdb92b
SPL ID: 48c0cb84-caef-ea0d-e063-6394a90a87de
Version: 3
Effective date: 2026-01-19
Source export date: 2026-09-28
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:14:57

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 number		M015	openfda.application_number
brand name		GRANULOTION Hemorrhoidal	openfda.brand_name
generic name		MENTHOL, ZINC OXIDE	openfda.generic_name
manufacturer name		GL Health, Inc.	openfda.manufacturer_name
ndc	package	82897-293-00	openfda.package_ndc
ndc	product	82897-293	openfda.product_ndc
ndc11	package	82897029300	derived:openfda.package_ndc
rxcui		1492398	openfda.rxcui
rxcui		1492403	openfda.rxcui
spl id		48c0cb84-caef-ea0d-e063-6394a90a87de	id
spl set id		1a32741c-5e4a-40e5-b15a-8233c5bdb92b	set_id
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 If condition worsens or does not improve within 7 days, consult a doctor Do not exceed the recommended daily dose unless directed by a doctor In case of bleeding, consult a doctor promptly Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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