Mirakel Pain Relief 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: Mirakel Pain Relief Roll-On
Generic name: LIDOCAINE HCL
Manufacturer: Sanvio, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 102f3618-13ad-37e3-e063-6294a90a8086
SPL ID: 102f3618-13ae-37e3-e063-6294a90a8086
Version: 1
Effective date: 2024-01-30
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 06:24:04

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		Mirakel Pain Relief Roll-On	openfda.brand_name
generic name		LIDOCAINE HCL	openfda.generic_name
manufacturer name		Sanvio, Inc.	openfda.manufacturer_name
ndc	package	78589-257-03	openfda.package_ndc
ndc	product	78589-257	openfda.product_ndc
ndc11	package	78589025703	derived:openfda.package_ndc
rxcui		1010077	openfda.rxcui
spl id		102f3618-13ae-37e3-e063-6294a90a8086	id
spl set id		102f3618-13ad-37e3-e063-6294a90a8086	set_id
unii		V13007Z41A	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

For external use only. Flammable-- keep away from fire or flame. Do not use if you have an allergic reaction to lidocaine or other local anesthetics on large areas of the body or on cut, irritated, blistered, or swollen skin on puncture wounds for more than one week without consulting a doctor Stop use and ask a doctor if condition worsens severe burning sensation, redness, rash, or irritation develops symptoms persist for more than 7 days or clear p and occur again within a few days you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

Reported adverse events (FAERS/openFDA)#

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