pharbinex-dm

Generic: guaifenesin 400mg and dextromethorphan hbr 20mg

Labeler: pharbest pharmaceuticals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pharbinex-dm
Generic Name guaifenesin 400mg and dextromethorphan hbr 20mg
Labeler pharbest pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Pharbest Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 16103-381
Product ID 16103-381_fcbabd90-abc6-4a05-8841-58cb74b5a22e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-04-02

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 16103381
Hyphenated Format 16103-381

Supplemental Identifiers

RxCUI
1147685
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 pharbinex-dm (source: ndc)
Generic Name guaifenesin 400mg and dextromethorphan hbr 20mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
  • 400 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (16103-381-04) / 30 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

16103-381-04 1 BOTTLE, PLASTIC in 1 CARTON (16103-381-04) / 30 TABLET in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

PHARBINEX-DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fcbabd90-abc6-4a05-8841-58cb74b5a22e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147685"], "spl_set_id": ["8d71db43-da87-45ee-aa4a-7e870bc5016d"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Pharbest Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16103-381-04)  / 30 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "16103-381-04", "marketing_start_date": "20180402"}], "brand_name": "PHARBINEX-DM", "product_id": "16103-381_fcbabd90-abc6-4a05-8841-58cb74b5a22e", "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": "16103-381", "generic_name": "GUAIFENESIN 400mg and DEXTROMETHORPHAN HBR 20MG", "labeler_name": "Pharbest Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PHARBINEX-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_start_date": "20180402", "listing_expiration_date": "20261231"}