Rocainol TOPICAL ANALGESIC

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: Rocainol TOPICAL ANALGESIC
Generic name: METHYL SALICYLATE, MENTHOL
Manufacturer: Compania Internacional de Comercio, S.A.P.I de C.V.
Product type: HUMAN OTC DRUG
SPL set ID: 827ec7b2-3d87-47e0-a47a-966b25732c32
SPL ID: 3998129b-973b-ecad-e063-6394a90acc89
Version: 10
Effective date: 2025-07-10
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:28:05

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		M017	openfda.application_number
brand name		Rocainol TOPICAL ANALGESIC	openfda.brand_name
generic name		METHYL SALICYLATE, MENTHOL	openfda.generic_name
manufacturer name		Compania Internacional de Comercio, S.A.P.I de C.V.	openfda.manufacturer_name
ndc	package	54312-825-01	openfda.package_ndc
ndc	product	54312-825	openfda.product_ndc
ndc11	package	54312082501	derived:openfda.package_ndc
rxcui		1306905	openfda.rxcui
rxcui		1306910	openfda.rxcui
spl id		3998129b-973b-ecad-e063-6394a90acc89	id
spl set id		827ec7b2-3d87-47e0-a47a-966b25732c32	set_id
unii		L7T10EIP3A	openfda.unii
unii		LAV5U5022Y	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 pregnant women and children under 12 years of age unless directed by a doctor Do not apply to wounds or damaged skin Do not bandage tightly Discontinue use if excessive irritation of the skin develops Keep this and all drugs out of the reach of children. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur 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.