Pramoxine Hydrochloride Anorectal

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: Pramoxine Hydrochloride Anorectal
Generic name: PRAMOXINE HYDROCHLORIDE
Manufacturer: Stratus Pharmaceuticals
Product type: HUMAN OTC DRUG
SPL set ID: 39a16b66-b0e9-412f-8773-8dec0a1227e0
SPL ID: a3ed95de-1df1-46d0-bc60-938274ffbc7d
Version: 1
Effective date: 2025-10-02
Source export date: 2026-09-28
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:16:52

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		Pramoxine Hydrochloride Anorectal	openfda.brand_name
generic name		PRAMOXINE HYDROCHLORIDE	openfda.generic_name
manufacturer name		Stratus Pharmaceuticals	openfda.manufacturer_name
ndc	package	58980-522-40	openfda.package_ndc
ndc	package	58980-522-80	openfda.package_ndc
ndc	product	58980-522	openfda.product_ndc
ndc11	package	58980052280	derived:openfda.package_ndc
ndc11	package	58980052240	derived:openfda.package_ndc
rxcui		1246075	openfda.rxcui
spl id		a3ed95de-1df1-46d0-bc60-938274ffbc7d	id
spl set id		39a16b66-b0e9-412f-8773-8dec0a1227e0	set_id
unii		88AYB867L5	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. Do not exceed the recommended daily dosage unless directed by a Physician. Do not put this product into rectum by using fingers or any applicator. Stop use and ask a Physician if Condition worsens Symptoms do not improve in 7 days Allergic reactions develop to ingredients in this product Symptoms being treated do not improve or subsideor if redness, irritation, swelling, pain, bleeding or other symptoms develop or increase Keep this product out of the reach of children. If swallowed, get medical attention or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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