llorens care tussin dm

Generic: dextromethorphan hbr, guaifenesin

Labeler: llorens pharmaceutical international division, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name llorens care tussin dm
Generic Name dextromethorphan hbr, guaifenesin
Labeler llorens pharmaceutical international division, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Llorens Pharmaceutical International Division, Inc.

Identifiers & Regulatory

Product NDC 54859-833
Product ID 54859-833_4743ed64-7bc4-9a11-e063-6294a90a76d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

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 54859833
Hyphenated Format 54859-833

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 llorens care tussin dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (54859-833-04)
source: ndc

Packages (1)

54859-833-04 118 mL in 1 BOTTLE (54859-833-04)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Llorens Care Tussin DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4743ed64-7bc4-9a11-e063-6294a90a76d1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["4743e562-1217-50ab-e063-6394a90af88d"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Llorens Pharmaceutical International Division, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (54859-833-04)", "package_ndc": "54859-833-04", "marketing_start_date": "20251201"}], "brand_name": "Llorens Care Tussin DM", "product_id": "54859-833_4743ed64-7bc4-9a11-e063-6294a90a76d1", "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": "54859-833", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Llorens Pharmaceutical International Division, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Llorens Care Tussin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}