tussin cough sugar free

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 cough sugar free
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 49580-0834
Product ID 49580-0834_e47f5029-661a-497e-aa8e-55520700b8d4
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

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 495800834
Hyphenated Format 49580-0834

Supplemental Identifiers

RxCUI
996520
UPC
0349580817043
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 cough sugar free (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
  • 1 BOTTLE, PLASTIC in 1 BOX (49580-0834-4) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

49580-0834-4 1 BOTTLE, PLASTIC in 1 BOX (49580-0834-4) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Tussin Cough Sugar Free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e47f5029-661a-497e-aa8e-55520700b8d4", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0349580817043"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["7ed2fe86-3346-4308-a9b6-6a264f879b02"], "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": "1 BOTTLE, PLASTIC in 1 BOX (49580-0834-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "49580-0834-4", "marketing_start_date": "20240731"}], "brand_name": "Tussin Cough Sugar Free", "product_id": "49580-0834_e47f5029-661a-497e-aa8e-55520700b8d4", "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": "49580-0834", "generic_name": "Dextromethorphan HBr Guaifenesin", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussin Cough Sugar Free", "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": "20240731", "listing_expiration_date": "20261231"}