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 48 of 153 · 3,057 matching rows.
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