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 26 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sabharwals LIDOCAINE 4% GEL PATCH Dr. Sabharwal's Wound Care 102399b6-5be9-ee5e-e063-6394a90a3198 2026-04-02 Warnings Exact identifier application number: M017 TATTOO NUMBX NUMBING PAIN RELIEVING LIDOCAINE HYDROCHLORIDE Scyberco Ltd ac8eac04-ed5b-4c8e-9f9b-54d160b74606 2026-04-02 Warnings Exact identifier application number: M017 FifthPulse Hydrocortisone HYDROCORTISONE WeCare Products LLC f1fcb045-4a15-431b-9617-67eae9f87fbd 2026-04-02 Warnings Exact identifier application number: M017 ANIXIKE Cream MENTHOL 5% CREAM Jiangxi Yudexi Pharmaceutical Co., LTD 4e8510e6-c0c7-bf6b-e063-6294a90a3b00 2026-04-02 Warnings Exact identifier application number: M017 RAPID RELIEF 0.025% CAPSAICIN PAIN PATCH 83569 4ed549e8-0062-fb03-e063-6294a90aac65 2026-04-02 Warnings Exact identifier application number: M017 Itch Relief DIPHENHYDRAMINE HCL AND ZINC ACETATE CVS Pharmacy 7e921988-ec66-38dc-e053-2a91aa0a7346 2026-04-01 Warnings Exact identifier application number: M017 The Best Numbing Cream TBNC The Best Numbing Cream LLC 4ca3923b-f586-0aaf-e063-6294a90a16c1 2026-03-31 Warnings Exact identifier application number: M017 ChapStick Classic Medicated EXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42798a6c-2d7e-80f6-e063-6294a90a105f 2026-03-31 Warnings Exact identifier application number: M017 Roll-On Pain Relief Liquid LIDOCAINE HCL HyVee Inc 4da6f6fb-b182-360f-e063-6294a90abdf3 2026-03-31 Warnings Exact identifier application number: M017 Hand Sanitizer ALCOHOL ProStat First Aid 4e54aecb-190f-3866-e063-6294a90a810a 2026-03-31 Warnings Exact identifier application number: M017 Burn Mist LIDOCAINE HYDROCHLORIDE Water-Jel Technologies c53ab9dd-351a-400b-b873-4f396e0af54d 2026-03-31 Warnings Exact identifier application number: M017 Satohap Lidocaine Hydrochloride 4 Percent Pain Relieving LIDOCAINE HYDROCHLORIDE Sato Pharmaceutical Co., Ltd. f7faddb2-5153-4fdd-a5ef-778182cef460 2026-03-31 Warnings Exact identifier application number: M017 ZENOL COOL METHYL SALICYLATE, L-MENTHOL BA TRADE INC 4e5c45f4-88ce-3a13-e063-6394a90a2a09 2026-03-31 Warnings Exact identifier application number: M017 Eagle Brand Medicated Roll On Refresh CAMPHOR, MENTHOL Borden Company (Private) Limited 091451fb-e30a-0012-e063-6394a90a3ba8 2026-03-31 Warnings Exact identifier application number: M017 Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and Mint MENTHOL Chattem, Inc. b16ba9c2-23bf-4fdf-b44b-7abb9fec1911 2026-03-31 Warnings Exact identifier application number: M017 DR.PABU NUMBING LIDOCAINE 5% NUMBING Jiangxi Yudexi Pharmaceutical Co., LTD 4e3a3c6c-4821-76ea-e063-6294a90a8f96 2026-03-30 Warnings Exact identifier application number: M017 Doctor Jiao Antifungal Cream MICONAZOLE NITRATE Jiangxi Haiwei Pharmaceutical Co., Ltd. 4e3b231e-0642-bf63-e063-6394a90a905b 2026-03-30 Warnings Exact identifier application number: M017 CVS Muscle Balm and Roll-On CAMPHOR, MENTHOL CVS Pharmacy 4e40025a-070a-508e-e063-6394a90af5d7 2026-03-30 Warnings Exact identifier application number: M017 REGENECARE HA LIDOCAINE HCL MPM Medical LLC c3eec066-38e8-4617-b34d-2f72ffb7a324 2026-03-30 Warnings Exact identifier application number: M017 Softlips Naturals Medicated Matcha Honey CAMPHOR, MENTHOL The Mentholatum Company 4e03a721-73f3-b2f2-e063-6394a90a44e6 2026-03-27 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