OPRAVA

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: OPRAVA
Generic name: METHYL SALICYLATE, MENTHOL, CAPSAICIN
Manufacturer: Biological M.D. Solutions LLC
Product type: HUMAN OTC DRUG
SPL set ID: 05552560-e283-5eba-e063-6294a90a65f7
SPL ID: 0e49fac4-c067-beb0-e063-6294a90ac96f
Version: 2
Effective date: 2024-01-06
Source export date: 2026-09-28
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/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:28

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		OPRAVA	openfda.brand_name
generic name		METHYL SALICYLATE, MENTHOL, CAPSAICIN	openfda.generic_name
manufacturer name		Biological M.D. Solutions LLC	openfda.manufacturer_name
ndc	package	83538-102-18	openfda.package_ndc
ndc	product	83538-102	openfda.product_ndc
ndc11	package	83538010218	derived:openfda.package_ndc
rxcui		2644111	openfda.rxcui
spl id		0e49fac4-c067-beb0-e063-6294a90ac96f	id
spl set id		05552560-e283-5eba-e063-6294a90a65f7	set_id
unii		S07O44R1ZM	openfda.unii
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

WARNING FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES, MUCOUS MEMBRANES AND BROKEN OR IRRITATED SKIN. IF CONDITION WORSENS, OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS, OR IF REDNESS IS PRESENT, DISCONTINUE USE AND CONSULT A PHYSICIAN. USE ONLY AS DIRECTED. NOT FOR USE IN CHILDREN UNDER 12 YEARS OF AGE.

Reported adverse events (FAERS/openFDA)#

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