guaiasorb dm

Generic: dextromethorphan hbr, guaifenesin

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

Drug Facts

Product Profile

Brand Name guaiasorb dm
Generic Name dextromethorphan hbr, guaifenesin
Labeler nucare pharmaceuticals, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
NuCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68071-3938
Product ID 68071-3938_46a4853c-c2a3-3a1a-e063-6294a90af402
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-10-01

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 680713938
Hyphenated Format 68071-3938

Supplemental Identifiers

RxCUI
996520
UPC
0368071393842
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 guaiasorb dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (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 (68071-3938-4)
source: ndc

Packages (1)

68071-3938-4 118 mL in 1 BOTTLE (68071-3938-4)

Ingredients (2)

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

Linked Drug Pages (1)

Guaiasorb DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46a4853c-c2a3-3a1a-e063-6294a90af402", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0368071393842"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["46a480c7-7092-b809-e063-6294a90a60cd"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["NuCare Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (68071-3938-4)", "package_ndc": "68071-3938-4", "marketing_start_date": "20251223"}], "brand_name": "Guaiasorb DM", "product_id": "68071-3938_46a4853c-c2a3-3a1a-e063-6294a90af402", "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": "68071-3938", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "NuCare Pharmaceuticals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaiasorb", "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": "20191001", "listing_expiration_date": "20261231"}