Doctor Butlers Hemorrhoid and Fissure External Pain Formula

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: Doctor Butlers Hemorrhoid and Fissure External Pain Formula
Generic name: LIDOCAINE 5%
Manufacturer: Beyond Health, P.A.
Product type: HUMAN OTC DRUG
SPL set ID: d92f22a7-c0b5-d8b8-e053-2a95a90a2376
SPL ID: 40079b30-9401-2783-e063-6394a90acd0b
Version: 6
Effective date: 2025-09-30
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 06:08:51

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 · 19 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M015	openfda.application_number
brand name		Doctor Butlers Hemorrhoid and Fissure External Pain Formula	openfda.brand_name
generic name		LIDOCAINE 5%	openfda.generic_name
manufacturer name		Beyond Health, P.A.	openfda.manufacturer_name
ndc	package	70942-121-75	openfda.package_ndc
ndc	package	70942-121-01	openfda.package_ndc
ndc	package	70942-121-07	openfda.package_ndc
ndc	package	70942-121-42	openfda.package_ndc
ndc	package	70942-121-11	openfda.package_ndc
ndc	product	70942-121	openfda.product_ndc
ndc11	package	70942012142	derived:openfda.package_ndc
ndc11	package	70942012101	derived:openfda.package_ndc
ndc11	package	70942012111	derived:openfda.package_ndc
ndc11	package	70942012175	derived:openfda.package_ndc
ndc11	package	70942012107	derived:openfda.package_ndc
rxcui		1366789	openfda.rxcui
spl id		40079b30-9401-2783-e063-6394a90acd0b	id
spl set id		d92f22a7-c0b5-d8b8-e053-2a95a90a2376	set_id
unii		98PI200987	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 including the skin of the anal canal When using this product avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reactions to ilgredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding ask a health care professional before use Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Cener right away.

Reported adverse events (FAERS/openFDA)#

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