mirakel pain and itch relief

Generic: benzocaine 20%, resorcinol 3%

Labeler: sanvio, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name mirakel pain and itch relief
Generic Name benzocaine 20%, resorcinol 3%
Labeler sanvio, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

benzocaine 20 g/100g, resorcinol 3 g/100g

Manufacturer
Sanvio, Inc.

Identifiers & Regulatory

Product NDC 78589-233
Product ID 78589-233_29b77abb-b9cb-c24d-e063-6394a90a8110
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-07-11

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78589233
Hyphenated Format 78589-233

Supplemental Identifiers

RxCUI
248341
UPC
0860008420008
UNII
U3RSY48JW5 YUL4LO94HK
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mirakel pain and itch relief (source: ndc)
Generic Name benzocaine 20%, resorcinol 3% (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 20 g/100g
  • 3 g/100g
source: ndc
Packaging
  • 95 g in 1 TUBE (78589-233-02)
source: ndc

Packages (1)

78589-233-02 95 g in 1 TUBE (78589-233-02)

Ingredients (2)

benzocaine (20 g/100g) resorcinol (3 g/100g)

Linked Drug Pages (1)

Mirakel Pain and Itch Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "29b77abb-b9cb-c24d-e063-6394a90a8110", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "upc": ["0860008420008"], "unii": ["U3RSY48JW5", "YUL4LO94HK"], "rxcui": ["248341"], "spl_set_id": ["ed34d728-0275-e209-e053-2995a90a93ff"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Sanvio, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "95 g in 1 TUBE (78589-233-02)", "package_ndc": "78589-233-02", "marketing_start_date": "20220711"}], "brand_name": "Mirakel Pain and Itch Relief", "product_id": "78589-233_29b77abb-b9cb-c24d-e063-6394a90a8110", "dosage_form": "CREAM", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "78589-233", "generic_name": "Benzocaine 20%, Resorcinol 3%", "labeler_name": "Sanvio, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mirakel Pain and Itch Relief", "active_ingredients": [{"name": "BENZOCAINE", "strength": "20 g/100g"}, {"name": "RESORCINOL", "strength": "3 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220711", "listing_expiration_date": "20261231"}