altituss

Generic: dextromethorphan hbr, guaifenesin

Labeler: alternative pharmacal corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name altituss
Generic Name dextromethorphan hbr, guaifenesin
Labeler alternative pharmacal corporation
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/7.5mL, guaifenesin 150 mg/7.5mL

Manufacturer
Alternative Pharmacal Corporation

Identifiers & Regulatory

Product NDC 53163-113
Product ID 53163-113_472ea5ae-3e91-42e3-e063-6294a90a4505
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-03-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53163113
Hyphenated Format 53163-113

Supplemental Identifiers

RxCUI
996520
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 altituss (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/7.5mL
  • 150 mg/7.5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (53163-113-16)
source: ndc

Packages (1)

53163-113-16 473 mL in 1 BOTTLE (53163-113-16)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/7.5mL) guaifenesin (150 mg/7.5mL)

Linked Drug Pages (1)

Altituss ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "472ea5ae-3e91-42e3-e063-6294a90a4505", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Alternative Pharmacal Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (53163-113-16)", "package_ndc": "53163-113-16", "marketing_start_date": "20150301"}], "brand_name": "Altituss", "product_id": "53163-113_472ea5ae-3e91-42e3-e063-6294a90a4505", "dosage_form": "LIQUID", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "53163-113", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Alternative Pharmacal Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Altituss", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/7.5mL"}, {"name": "GUAIFENESIN", "strength": "150 mg/7.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150301", "listing_expiration_date": "20261231"}