elixirtripleguard triple antibiotic

Generic: miconazole nitrate cream

Labeler: elixir healthcare usa, llc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name elixirtripleguard triple antibiotic
Generic Name miconazole nitrate cream
Labeler elixir healthcare usa, llc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

miconazole nitrate 2 g/100g

Manufacturer
ELIXIR HEALTHCARE USA, LLC.

Identifiers & Regulatory

Product NDC 84546-0007
Product ID 84546-0007_48749d03-2194-b2d4-e063-6394a90a731f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2027-12-31
Marketing Start 2025-12-31

Pharmacologic Class

Classes
azole antifungal [epc] azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 845460007
Hyphenated Format 84546-0007

Supplemental Identifiers

RxCUI
998483
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 elixirtripleguard triple antibiotic (source: ndc)
Generic Name miconazole nitrate cream (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 2 g/100g
source: ndc
Packaging
  • 113 g in 1 TUBE (84546-0007-1)
source: ndc

Packages (1)

84546-0007-1 113 g in 1 TUBE (84546-0007-1)

Ingredients (1)

miconazole nitrate (2 g/100g)

Linked Drug Pages (1)

ElixirTripleGuard Triple Antibiotic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48749d03-2194-b2d4-e063-6394a90a731f", "openfda": {"unii": ["VW4H1CYW1K"], "rxcui": ["998483"], "spl_set_id": ["0482ce9f-c98a-4f37-8b37-6df1738b6da3"], "manufacturer_name": ["ELIXIR HEALTHCARE USA, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "113 g in 1 TUBE (84546-0007-1)", "package_ndc": "84546-0007-1", "marketing_start_date": "20251231"}], "brand_name": "ElixirTripleGuard Triple Antibiotic", "product_id": "84546-0007_48749d03-2194-b2d4-e063-6394a90a731f", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "84546-0007", "generic_name": "Miconazole Nitrate cream", "labeler_name": "ELIXIR HEALTHCARE USA, LLC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ElixirTripleGuard", "brand_name_suffix": "Triple Antibiotic", "active_ingredients": [{"name": "MICONAZOLE NITRATE", "strength": "2 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251231", "listing_expiration_date": "20271231"}