miconatate

Generic: miconazole nitrate and tolnaftate

Labeler: puretek corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name miconatate
Generic Name miconazole nitrate and tolnaftate
Labeler puretek corporation
Dosage Form KIT
Manufacturer
PureTek Corporation

Identifiers & Regulatory

Product NDC 59088-778
Product ID 59088-778_249cf0cd-2c2a-95a1-e063-6394a90af393
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2021-09-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59088778
Hyphenated Format 59088-778

Supplemental Identifiers

RxCUI
313423 998461

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 miconatate (source: ndc)
Generic Name miconazole nitrate and tolnaftate (source: ndc)
Application Number 505G(a)(3) (source: ndc)

Resolved Composition

Strengths
  • 30 ml
  • 2 %
  • 1 %
source: label
Packaging
  • 1 KIT in 1 CARTON (59088-778-00) * 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) * 85 g in 1 BOTTLE (59088-442-07)
source: ndc

Packages (1)

59088-778-00 1 KIT in 1 CARTON (59088-778-00) * 30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03) * 85 g in 1 BOTTLE (59088-442-07)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Miconatate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "249cf0cd-2c2a-95a1-e063-6394a90af393", "openfda": {"rxcui": ["313423", "998461"], "spl_set_id": ["c45c8f8f-9042-a428-e053-2a95a90acda9"], "manufacturer_name": ["PureTek Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (59088-778-00)  *  30 mL in 1 BOTTLE, WITH APPLICATOR (59088-443-03)  *  85 g in 1 BOTTLE (59088-442-07)", "package_ndc": "59088-778-00", "marketing_start_date": "20210902"}], "brand_name": "Miconatate", "product_id": "59088-778_249cf0cd-2c2a-95a1-e063-6394a90af393", "dosage_form": "KIT", "product_ndc": "59088-778", "generic_name": "Miconazole Nitrate and Tolnaftate", "labeler_name": "PureTek Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Miconatate", "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210902", "listing_expiration_date": "20261231"}