ROPANA Pain Relief Cream

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: ROPANA Pain Relief Cream
Generic name: HISTAMINE DIHYDROCHLORIDE
Manufacturer: FUSION PAIN SOLUTIONS LLC
Product type: HUMAN OTC DRUG
SPL set ID: e0342aa3-ca80-40b7-bec6-1b33c4db398b
SPL ID: 09765451-b4c7-6a8d-e063-6294a90aa698
Version: 2
Effective date: 2023-11-06
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:52:50

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		M017	openfda.application_number
brand name		ROPANA Pain Relief Cream	openfda.brand_name
generic name		HISTAMINE DIHYDROCHLORIDE	openfda.generic_name
manufacturer name		FUSION PAIN SOLUTIONS LLC	openfda.manufacturer_name
ndc	package	83613-411-00	openfda.package_ndc
ndc	product	83613-411	openfda.product_ndc
ndc11	package	83613041100	derived:openfda.package_ndc
rxcui		2645121	openfda.rxcui
spl id		09765451-b4c7-6a8d-e063-6294a90aa698	id
spl set id		e0342aa3-ca80-40b7-bec6-1b33c4db398b	set_id
unii		3POA0Q644U	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 use on damaged or broken skin. When using this product Avoid contact with the eyes. Stop use and ask a doctor if Rash or irritation develops and lasts. Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Reported adverse events (FAERS/openFDA)#

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