Mirakel Pain and Itch Relief

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 and Itch Relief
Generic name: BENZOCAINE 20%, RESORCINOL 3%
Manufacturer: Sanvio, Inc.
Product type: HUMAN OTC DRUG
SPL set ID: ed34d728-0275-e209-e053-2995a90a93ff
SPL ID: 29b77abb-b9cb-c24d-e063-6394a90a8110
Version: 2
Effective date: 2024-12-20
Source export date: 2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:53:01

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 · 12 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Mirakel Pain and Itch Relief	openfda.brand_name
generic name		BENZOCAINE 20%, RESORCINOL 3%	openfda.generic_name
manufacturer name		Sanvio, Inc.	openfda.manufacturer_name
ndc	package	78589-233-02	openfda.package_ndc
ndc	product	78589-233	openfda.product_ndc
ndc11	package	78589023302	derived:openfda.package_ndc
rxcui		248341	openfda.rxcui
spl id		29b77abb-b9cb-c24d-e063-6394a90a8110	id
spl set id		ed34d728-0275-e209-e053-2995a90a93ff	set_id
unii		U3RSY48JW5	openfda.unii
unii		YUL4LO94HK	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. Do not use over large areas of the body. Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics. When using this product avoid contact with eyes, use only as directed. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days, symptoms clear up and occur again within a few days, itching, rash or irritation develops.

Reported adverse events (FAERS/openFDA)#

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