tussin dm cough and chest congestion adult

Generic: dextromethorphan hbr, guaifenesin

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tussin dm cough and chest congestion adult
Generic Name dextromethorphan hbr, guaifenesin
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/10mL, guaifenesin 200 mg/10mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0385
Product ID 49580-0385_8228de33-953b-42ee-9bad-286bd3665934
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-03-31

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 495800385
Hyphenated Format 49580-0385

Supplemental Identifiers

RxCUI
1605844
UPC
0349580385047
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 tussin dm cough and chest congestion adult (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE, PLASTIC (49580-0385-2)
  • 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) / 118 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-8) / 237 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

49580-0385-2 118 mL in 1 BOTTLE, PLASTIC (49580-0385-2) 49580-0385-4 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) / 118 mL in 1 BOTTLE, PLASTIC 49580-0385-8 1 BOTTLE, PLASTIC in 1 BOX (49580-0385-8) / 237 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (20 mg/10mL) guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Tussin DM Cough and Chest Congestion Adult ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8228de33-953b-42ee-9bad-286bd3665934", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0349580385047"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1605844"], "spl_set_id": ["4af67ba7-8892-442c-b9fb-80aba9140e05"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (49580-0385-2)", "package_ndc": "49580-0385-2", "marketing_start_date": "20150331"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (49580-0385-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0385-4", "marketing_start_date": "20150331"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (49580-0385-8)  / 237 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0385-8", "marketing_start_date": "20150331"}], "brand_name": "Tussin DM Cough and Chest Congestion Adult", "product_id": "49580-0385_8228de33-953b-42ee-9bad-286bd3665934", "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": "49580-0385", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussin DM Cough and Chest Congestion", "brand_name_suffix": "Adult", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150331", "listing_expiration_date": "20261231"}