libi air virlaza dextromethorphan cough suppressant

Generic: dextromethorphan

Labeler: libi pharm ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name libi air virlaza dextromethorphan cough suppressant
Generic Name dextromethorphan
Labeler libi pharm ltd.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

dextromethorphan 10 mg/mL

Manufacturer
Libi Pharm Ltd.

Identifiers & Regulatory

Product NDC 84314-000
Product ID 84314-000_383c21e8-3753-16c8-e063-6394a90af170
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-01-07

Pharmacologic Class

Established (EPC)
uncompetitive n-methyl-d-aspartate receptor antagonist [epc] sigma-1 agonist [epc]
Mechanism of Action
uncompetitive nmda receptor antagonists [moa] sigma-1 receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84314000
Hyphenated Format 84314-000

Supplemental Identifiers

UNII
7355X3ROTS
NUI
N0000181821 N0000182149 N0000181819 N0000182147

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 libi air virlaza dextromethorphan cough suppressant (source: ndc)
Generic Name dextromethorphan (source: ndc)
Application Number M012 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (84314-000-30) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

84314-000-30 1 BOTTLE in 1 BOX (84314-000-30) / 30 mL in 1 BOTTLE

Ingredients (1)

dextromethorphan (10 mg/mL)

Linked Drug Pages (1)

LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "383c21e8-3753-16c8-e063-6394a90af170", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147"], "unii": ["7355X3ROTS"], "spl_set_id": ["e4eea307-0a68-4f7d-b880-df231d3af724"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["Libi Pharm Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (84314-000-30)  / 30 mL in 1 BOTTLE", "package_ndc": "84314-000-30", "marketing_start_date": "20240107"}], "brand_name": "LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant", "product_id": "84314-000_383c21e8-3753-16c8-e063-6394a90af170", "dosage_form": "LIQUID", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "84314-000", "generic_name": "DEXTROMETHORPHAN", "labeler_name": "Libi Pharm Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LIBI AIR VIRLAZA Dextromethorphan Cough Suppressant", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "10 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240107", "listing_expiration_date": "20261231"}