adult bisolvine adult

Generic: guaifenesin, dextromethorphan

Labeler: menper distributors inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name adult bisolvine adult
Generic Name guaifenesin, dextromethorphan
Labeler menper distributors inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/10mL, guaifenesin 200 mg/10mL

Manufacturer
MENPER DISTRIBUTORS INC.

Identifiers & Regulatory

Product NDC 53145-323
Product ID 53145-323_3d3520bc-498c-922f-e063-6394a90a9a62
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-05-01

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 53145323
Hyphenated Format 53145-323

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 adult bisolvine adult (source: ndc)
Generic Name guaifenesin, dextromethorphan (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (53145-323-04)
source: ndc

Packages (1)

53145-323-04 120 mL in 1 BOTTLE, PLASTIC (53145-323-04)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/10mL) guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Adult Bisolvine Adult ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d3520bc-498c-922f-e063-6394a90a9a62", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["8cde5e39-a338-45af-b847-3823627f29c5"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["MENPER DISTRIBUTORS INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (53145-323-04)", "package_ndc": "53145-323-04", "marketing_start_date": "20250501"}], "brand_name": "Adult Bisolvine Adult", "product_id": "53145-323_3d3520bc-498c-922f-e063-6394a90a9a62", "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": "53145-323", "generic_name": "Guaifenesin, Dextromethorphan", "labeler_name": "MENPER DISTRIBUTORS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Adult Bisolvine", "brand_name_suffix": "Adult", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250501", "listing_expiration_date": "20261231"}