guaifenesin dm (43063-801)

Drug Facts

Product Profile

Brand Name guaifenesin dm

Generic Name guaifenesin and dextromethorphan hydrobromide

Labeler pd-rx pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 20 mg/1, guaifenesin 400 mg/1

Manufacturer

PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-801

Product ID 43063-801_06c3176d-e6f9-4231-e063-6394a90a694b

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Marketing Start 2018-04-02

Marketing End 2027-11-30

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 43063801

Hyphenated Format 43063-801

Supplemental Identifiers

RxCUI

1147685

UPC

0343063801307

UNII

9D2RTI9KYH 495W7451VQ

NUI

N0000193956 N0000008867 N0000009560

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 hydrobromide (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/1
400 mg/1

source: ndc

Packaging

30 TABLET in 1 BOTTLE, PLASTIC (43063-801-30)
60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60)
90 TABLET in 1 BOTTLE, PLASTIC (43063-801-90)

source: ndc

Packages (3)

43063-801-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-801-30) 43063-801-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60) 43063-801-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-801-90)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/1) guaifenesin (400 mg/1)

Linked Drug Pages (1)

Guaifenesin DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "06c3176d-e6f9-4231-e063-6394a90a694b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0343063801307"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147685"], "spl_set_id": ["ac8c0c15-b305-47f2-8712-e4b53636f7fa"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-801-30)", "package_ndc": "43063-801-30", "marketing_end_date": "20271130", "marketing_start_date": "20180402"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-801-60)", "package_ndc": "43063-801-60", "marketing_end_date": "20271130", "marketing_start_date": "20180402"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-801-90)", "package_ndc": "43063-801-90", "marketing_end_date": "20271130", "marketing_start_date": "20180402"}], "brand_name": "Guaifenesin DM", "product_id": "43063-801_06c3176d-e6f9-4231-e063-6394a90a694b", "dosage_form": "TABLET", "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": "43063-801", "generic_name": "GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/1"}, {"name": "GUAIFENESIN", "strength": "400 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20271130", "marketing_start_date": "20180402"}