tussin severe

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin

Labeler: hyvee inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tussin severe
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin
Labeler hyvee inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/20mL, dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 400 mg/20mL

Manufacturer
HyVee Inc

Identifiers & Regulatory

Product NDC 42507-581
Product ID 42507-581_a7579536-66bf-454f-9eaf-6a150bb7afc5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-28

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 42507581
Hyphenated Format 42507-581

Supplemental Identifiers

RxCUI
2680300
UNII
362O9ITL9D 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 tussin severe (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/20mL
  • 20 mg/20mL
  • 400 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (42507-581-26) / 118 mL in 1 BOTTLE (42507-581-00)
source: ndc

Packages (1)

42507-581-26 1 BOTTLE in 1 CARTON (42507-581-26) / 118 mL in 1 BOTTLE (42507-581-00)

Ingredients (3)

acetaminophen (650 mg/20mL) dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (400 mg/20mL)

Linked Drug Pages (1)

Tussin Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a7579536-66bf-454f-9eaf-6a150bb7afc5", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2680300"], "spl_set_id": ["85252999-3463-45fe-b4a9-7a97960b41b1"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["HyVee Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (42507-581-26)  / 118 mL in 1 BOTTLE (42507-581-00)", "package_ndc": "42507-581-26", "marketing_start_date": "20260128"}], "brand_name": "Tussin Severe", "product_id": "42507-581_a7579536-66bf-454f-9eaf-6a150bb7afc5", "dosage_form": "SOLUTION", "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": "42507-581", "generic_name": "acetaminophen, dextromethorphan hydrobromide, guaifenesin", "labeler_name": "HyVee Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussin Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/20mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260128", "listing_expiration_date": "20271231"}