Home NDC 78589-233 Mirakel Pain and Itch Relief
Product NDC 78589-233
11-digit product format 785890233
Labeler code 78589
Product ID 78589-233_29b77abb-b9cb-c24d-e063-6394a90a8110
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine 20%, Resorcinol 3%
Dosage form CREAM
Route TOPICAL
Labeler Sanvio, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-07-11
Substance BENZOCAINE; RESORCINOL
Active strength 20; 3 g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Mirakel Pain and Itch Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 20 g/100g RESORCINOL 3 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup YUL4LO94HK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248341 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78589-233-02 Mirakel Pain and Itch Relief 95 g in 1 TUBE CREAM 95 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78589-233 MIRAKEL PAIN AND ITCH RELIEF (BENZOCAINE 20%, RESORCINOL 3%) CREAM [SANVIO, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241222_ed34d728-0275-e209-e053-2995a90a93ff.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 7 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cortizone 10 Itch Relief Massaging Rollerball HYDROCORTISONE Chattem, Inc. 1e27682c-f856-41f1-9935-37540960a4c7 2026-07-31 Warnings Exact identifier application number: M017 Aspercreme with Lidocaine Dry LIDOCAINE Chattem, Inc. 008abaaa-5e12-4246-a7f5-66f3966acf28 2026-07-30 Warnings Exact identifier application number: M017 ACOLYE Lidocaine Cream Topical Analgesia Cream LIDOCAINE,MENTHOL Guangdong Aimu Biological Technology Co., Ltd 57deebf7-52f1-4256-e063-6294a90a75d5 2026-07-30 Warnings Exact identifier application number: M017 Icy Hot Performance No-Mess Pain Relief Cream MENTHOL 16%, CAMPHOR 11% Chattem, Inc. 5e3e272a-c001-4f57-9535-521ccc85ae65 2026-07-30 Warnings Exact identifier application number: M017 Auixudin Lidocaine Pain Relief Gel-Patch LIDOCAINE PAIN RELIEF GEL-PATCH Henan Enokon Medical Instrument Co., Ltd. 57bc7b9e-e2f7-724b-e063-6394a90ab36f 2026-07-29 Warnings Exact identifier application number: M017 Jinfahe Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 57bcd9c5-767e-b634-e063-6394a90a2878 2026-07-29 Warnings Exact identifier application number: M017 Maximun Strength Lidocaine Patch Plus Menthol LIDOCAINE, MENTHOL Meijer Distribution Inc d0468514-58ea-4d8f-b634-a65bf95c0316 2026-07-29 Warnings Exact identifier application number: M017 Oudetas Lidocaine Cream LIDOCAINE CREAM Guangzhou Jingliang Cosmetics Co., Ltd. 57ca9220-2778-790a-e063-6294a90af506 2026-07-29 Warnings Exact identifier application number: M017 Aspercreme Lidocaine No-Mess plus Lavender LIDOCAINE HCL Chattem, Inc. 3948a3d2-ce04-4703-8709-211e75c9c38d 2026-07-29 Warnings Exact identifier application number: M017 Aspercreme Professional Cream LIDOCAINE HCL 4% Chattem, Inc. ef297864-5917-4645-8ec7-f2bc49e037e8 2026-07-29 Warnings Exact identifier application number: M017 LidoPro LIDOCAINE AND MENTHOL Clinic Pharma cdfd6b39-b430-4e95-a0f7-682cf3d78b52 2026-07-28 Warnings Exact identifier application number: M017 LidoPro Patch (Lidocaine 4%, Menthol 1%) LIDOCAINE AND MENTHOL PATCH Clinic Pharma 2b4d2105-b7ad-2695-e063-6394a90a999b 2026-07-28 Warnings Exact identifier application number: M017 HEMPE Ice Muscle and Joint Gel MENTHOL Healthcare International Research Limited 57aec922-1de4-c579-e063-6394a90af6c8 2026-07-28 Warnings Exact identifier application number: M017 Earths Care Pain Relieving CAMPHOR, MENTHOL, METHYL SALICYLATE DLC Laboratories, Inc. 5c3976da-a6cb-4b94-ae41-3e86b1ab13cb 2026-07-28 Warnings Exact identifier application number: M017 Muscle Rub Cream MENTHOL 10%, METHYL SALICYLATE 15% Preferred Pharmaceuticals Inc. 9e7568b6-52ae-4f7a-9bfd-503fd80a297e 2026-07-28 Warnings Exact identifier application number: M017 Aspercreme Lidocaine with Rosemary and Mint LIDOCAINE HYDROCHLORIDE Chattem, Inc. 9d40bfea-85d0-4943-83e9-0c16e79a011c 2026-07-28 Warnings Exact identifier application number: M017 KENS PAIN AND ARTHRITIS FORMULA MENTHOL Eezaway Relief Inc 35834473-3ad5-41ec-a110-e742aa7e2ee4 2026-07-28 Warnings Exact identifier application number: M017 DERMFREE Lidocaine 4% NUMBING Topical Anorectal Cream LIDOCAINE 4% NUMBING TOPICAL ANORECTAL CREAM Wenzhou Yuyuan Pharmaceutical Co., Ltd. 57935b64-6e2e-85d0-e063-6394a90a7428 2026-07-27 Warnings Exact identifier application number: M017 1% Hydrocortisone Anti-itch 1% HYDROCORTISONE ANTI-ITCH ALAINA HEALTHCARE PRIVATE LIMITED b8416467-55f7-4e5f-a5cb-3abd3e2bb577 2026-07-27 Warnings Exact identifier application number: M017 OWELL NATURALS ARTHRITIS MAXIMUM STRENGTH MENTHOL OWELL NATURAL 8 LLC 57984bc2-bf1d-c423-e063-6394a90a06ae 2026-07-27 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78589-233-02 78589023302 95 g in 1 TUBE (78589-233-02) 95 g 2022-07-11 0000-00-00 No No Current