guaifenesin dm

Generic: guaifenesin and dextromethorphan

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name guaifenesin dm
Generic Name guaifenesin and dextromethorphan
Labeler pai holdings, llc dba pai pharma
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-1276
Product ID 0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 1992-07-01

Pharmacologic Class

Established (EPC)
uncompetitive n-methyl-d-aspartate receptor antagonist [epc] sigma-1 agonist [epc] expectorant [epc]
Mechanism of Action
uncompetitive nmda receptor antagonists [moa] sigma-1 receptor agonists [moa]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01211276
Hyphenated Format 0121-1276

Supplemental Identifiers

RxCUI
996520
UPC
0301210638046 0301210638169
UNII
7355X3ROTS 495W7451VQ
NUI
N0000181821 N0000182149 N0000181819 N0000182147 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 dm (source: ndc)
Generic Name guaifenesin and dextromethorphan (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)
source: ndc

Packages (1)

0121-1276-00 10 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)

Ingredients (2)

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

Linked Drug Pages (1)

GUAIFENESIN DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c50b4c5c-6f55-4118-a282-e0b490704e49", "openfda": {"nui": ["N0000181821", "N0000182149", "N0000181819", "N0000182147", "N0000193956", "N0000008867", "N0000009560"], "upc": ["0301210638046", "0301210638169"], "unii": ["7355X3ROTS", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["ff970fff-d1a3-4322-83b4-34e361431a1c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Sigma-1 Agonist [EPC]", "Expectorant [EPC]"], "pharm_class_moa": ["Uncompetitive NMDA Receptor Antagonists [MoA]", "Sigma-1 Receptor Agonists [MoA]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-1276-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10)", "package_ndc": "0121-1276-00", "marketing_start_date": "19920701"}], "brand_name": "GUAIFENESIN DM", "product_id": "0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49", "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": "0121-1276", "generic_name": "GUAIFENESIN and DEXTROMETHORPHAN", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "GUAIFENESIN DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19920701", "listing_expiration_date": "20261231"}