Pain Relieving Roll-On

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: Pain Relieving Roll-On
Generic name: MENTHOL, UNSPECIFIED FORM
Manufacturer: Safetec of America, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 80118260-9c88-402d-9a90-ecfe62b4b54f
SPL ID: 10a91ff8-4d59-15dd-e063-6394a90a3aad
Version: 2
Effective date: 2024-02-05
Source export date: 2026-10-30
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:33:26

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		Pain Relieving Roll-On	openfda.brand_name
generic name		MENTHOL, UNSPECIFIED FORM	openfda.generic_name
manufacturer name		Safetec of America, Inc.	openfda.manufacturer_name
ndc	package	61010-1550-1	openfda.package_ndc
ndc	product	61010-1550	openfda.product_ndc
ndc11	package	61010155001	derived:openfda.package_ndc
rxcui		311509	openfda.rxcui
spl id		10a91ff8-4d59-15dd-e063-6394a90a3aad	id
spl set id		80118260-9c88-402d-9a90-ecfe62b4b54f	set_id
unii		L7T10EIP3A	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. Flammable. Keep away from flame. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away. Avoid contact with eyes. Do not apply to open wounds or damaged skin. Do not bandage tightly. Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

Reported adverse events (FAERS/openFDA)#

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