guaifenesin syrup and dextromethorphan

Generic: guaifenesin syrup and dextromethorphan

Labeler: natco pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin syrup and dextromethorphan
Generic Name guaifenesin syrup and dextromethorphan
Labeler natco pharma usa llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
Natco Pharma USA LLC

Identifiers & Regulatory

Product NDC 69339-150
Product ID 69339-150_6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-10-19

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 69339150
Hyphenated Format 69339-150

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 guaifenesin syrup and dextromethorphan (source: ndc)
Generic Name guaifenesin syrup and dextromethorphan (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (69339-150-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-150-01)
source: ndc

Packages (1)

69339-150-19 10 TRAY in 1 CASE (69339-150-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-150-01)

Ingredients (2)

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

Linked Drug Pages (1)

Guaifenesin Syrup and Dextromethorphan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["ad9026f4-f0b6-4d02-aa44-f0460eeefc0e"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Natco Pharma USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (69339-150-19)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (69339-150-01)", "package_ndc": "69339-150-19", "marketing_start_date": "20201019"}], "brand_name": "Guaifenesin Syrup and Dextromethorphan", "product_id": "69339-150_6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd", "dosage_form": "SYRUP", "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": "69339-150", "generic_name": "Guaifenesin Syrup and Dextromethorphan", "labeler_name": "Natco Pharma USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin Syrup and Dextromethorphan", "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": "20201019", "listing_expiration_date": "20261231"}