monistat 3 3 day

Generic: miconazole nitrate

Labeler: insight pharmaceuticals llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name monistat 3 3 day
Generic Name miconazole nitrate
Labeler insight pharmaceuticals llc
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

miconazole nitrate 40 mg/g

Manufacturer
Insight Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 63736-015
Product ID 63736-015_09cb5f1c-b40a-426f-94d0-ec18662feb0f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020827
Listing Expiration 2026-12-31
Marketing Start 1998-03-30

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63736015
Hyphenated Format 63736-015

Supplemental Identifiers

RxCUI
998544 998546
UNII
VW4H1CYW1K

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 monistat 3 3 day (source: ndc)
Generic Name miconazole nitrate (source: ndc)
Application Number NDA020827 (source: ndc)
Routes
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/g
source: ndc
Packaging
  • 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR
  • 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR
source: ndc

Packages (2)

63736-015-18 3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18) / 5 g in 1 TUBE, WITH APPLICATOR 63736-015-25 1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25) / 25 g in 1 TUBE, WITH APPLICATOR

Ingredients (1)

miconazole nitrate (40 mg/g)

Linked Drug Pages (1)

Monistat 3 3 Day ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "09cb5f1c-b40a-426f-94d0-ec18662feb0f", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998544", "998546"], "spl_set_id": ["f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5"], "manufacturer_name": ["Insight Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-18)  / 5 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "63736-015-18", "marketing_start_date": "19980330"}, {"sample": false, "description": "1 TUBE, WITH APPLICATOR in 1 CARTON (63736-015-25)  / 25 g in 1 TUBE, WITH APPLICATOR", "package_ndc": "63736-015-25", "marketing_start_date": "19980330"}], "brand_name": "Monistat 3 3 Day", "product_id": "63736-015_09cb5f1c-b40a-426f-94d0-ec18662feb0f", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "63736-015", "generic_name": "Miconazole Nitrate", "labeler_name": "Insight Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Monistat 3", "brand_name_suffix": "3 Day", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "40 mg/g"}], "application_number": "NDA020827", "marketing_category": "NDA", "marketing_start_date": "19980330", "listing_expiration_date": "20261231"}