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

Additional Listing Data#

Finished product
Yes
Brand name base
Mirakel Pain and Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
RESORCINOL3 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, YUL4LO94HK
Rxcui248341

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78589-233-02Mirakel Pain and Itch Relief95 g in 1 TUBECREAM952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78589-233MIRAKEL PAIN AND ITCH RELIEF (BENZOCAINE 20%, RESORCINOL 3%) CREAM [SANVIO, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_ed34d728-0275-e209-e053-2995a90a93ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248341benzocaine 20 % / resorcinol 3 % Topical CreamPSNed34d728-0275-e209-e053-2995a90a93ff2
248341benzocaine 200 MG/ML / resorcinol 30 MG/ML Topical CreamSCDed34d728-0275-e209-e053-2995a90a93ff2
248341benzocaine 20 % / resorcinol 3 % Topical CreamSYed34d728-0275-e209-e053-2995a90a93ff2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78589-233-027858902330295 g in 1 TUBE (78589-233-02) 95 g2022-07-110000-00-00NoNoCurrent