Hemorroidal Cooling gel

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: Hemorroidal Cooling gel
Generic name: PHENYLEPHRINE, WITCH HAZEL
Manufacturer: Trifecta Pharmaceuticals Usa Llc
Product type: HUMAN OTC DRUG
SPL set ID: 651c0143-384c-3649-e053-2991aa0a0f28
SPL ID: 298d9e2d-7fff-7f15-e063-6394a90a1639
Version: 6
Effective date: 2024-12-18
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 02:02:12

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Hemorroidal Cooling gel	openfda.brand_name
generic name		PHENYLEPHRINE, WITCH HAZEL	openfda.generic_name
manufacturer name		Trifecta Pharmaceuticals Usa Llc	openfda.manufacturer_name
ndc	package	69396-032-18	openfda.package_ndc
ndc	product	69396-032	openfda.product_ndc
ndc11	package	69396003218	derived:openfda.package_ndc
spl id		298d9e2d-7fff-7f15-e063-6394a90a1639	id
spl set id		651c0143-384c-3649-e053-2991aa0a0f28	set_id
unii		101I4J0U34	openfda.unii
unii		04JA59TNSJ	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 Ask doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty urinating due to an enlarged prostate gland Ask doctor before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put into the rectum by using fingers or any mechanical device or applicator

Reported adverse events (FAERS/openFDA)#

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