dextromethorphan hbr. and guaifenesin

Generic: dextromethorphan hbr. and guaifenesin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dextromethorphan hbr. and guaifenesin
Generic Name dextromethorphan hbr. and guaifenesin
Labeler rising pharma holdings, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-312
Product ID 57237-312_914d13bb-fbd6-420f-ad2c-1df3828d18c3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012.85
Listing Expiration 2026-12-31
Marketing Start 2023-06-12

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 57237312
Hyphenated Format 57237-312

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 dextromethorphan hbr. and guaifenesin (source: ndc)
Generic Name dextromethorphan hbr. and guaifenesin (source: ndc)
Application Number M012.85 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)
source: ndc

Packages (1)

57237-312-51 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)

Ingredients (2)

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

Linked Drug Pages (1)

Dextromethorphan HBr. and Guaifenesin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "914d13bb-fbd6-420f-ad2c-1df3828d18c3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["e463e60f-d0db-4ee7-9713-ddf25aa38a43"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51)  / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)", "package_ndc": "57237-312-51", "marketing_start_date": "20230612"}], "brand_name": "Dextromethorphan HBr. and Guaifenesin", "product_id": "57237-312_914d13bb-fbd6-420f-ad2c-1df3828d18c3", "dosage_form": "SOLUTION", "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": "57237-312", "generic_name": "Dextromethorphan HBr. and Guaifenesin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dextromethorphan HBr. and Guaifenesin", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012.85", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230612", "listing_expiration_date": "20261231"}