mucolyte dm

Generic: guaifenesin, dextromethorphan hbr

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

Drug Facts

Product Profile

Brand Name mucolyte dm
Generic Name guaifenesin, dextromethorphan hbr
Labeler rising pharma holdings, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-360
Product ID 57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-22

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 57237360
Hyphenated Format 57237-360

Supplemental Identifiers

RxCUI
996520
UPC
0357237360163
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 mucolyte dm (source: ndc)
Generic Name guaifenesin, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (57237-360-12)
  • 473 mL in 1 BOTTLE (57237-360-16)
source: ndc

Packages (2)

57237-360-12 118 mL in 1 BOTTLE (57237-360-12) 57237-360-16 473 mL in 1 BOTTLE (57237-360-16)

Ingredients (2)

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

Linked Drug Pages (1)

Mucolyte DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e0d8faa2-7ca9-49c9-bae0-138fea576c68", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0357237360163"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["c913d27d-bc00-4ace-9a5f-c55522e1cd1d"], "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": "118 mL in 1 BOTTLE (57237-360-12)", "package_ndc": "57237-360-12", "marketing_start_date": "20251222"}, {"sample": false, "description": "473 mL in 1 BOTTLE (57237-360-16)", "package_ndc": "57237-360-16", "marketing_start_date": "20251222"}], "brand_name": "Mucolyte DM", "product_id": "57237-360_e0d8faa2-7ca9-49c9-bae0-138fea576c68", "dosage_form": "LIQUID", "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": "57237-360", "generic_name": "Guaifenesin, Dextromethorphan HBr", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucolyte", "brand_name_suffix": "DM", "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": "20251222", "listing_expiration_date": "20261231"}