bisolvine children

Generic: guaifenesin, dextromethorphan

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

Drug Facts

Product Profile

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

dextromethorphan hydrobromide 10 mg/15mL, guaifenesin 100 mg/15mL

Manufacturer
MENPER DISTRIBUTORS INC.

Identifiers & Regulatory

Product NDC 53145-322
Product ID 53145-322_3a8ae821-335c-8faf-e063-6394a90ab4bd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2010-01-18

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 53145322
Hyphenated Format 53145-322

Supplemental Identifiers

RxCUI
1298228
UPC
0042279802046
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 bisolvine children (source: ndc)
Generic Name guaifenesin, dextromethorphan (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/15mL
  • 100 mg/15mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53145-322-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

53145-322-04 1 BOTTLE in 1 CARTON (53145-322-04) / 120 mL in 1 BOTTLE

Ingredients (2)

dextromethorphan hydrobromide (10 mg/15mL) guaifenesin (100 mg/15mL)

Linked Drug Pages (1)

Bisolvine Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a8ae821-335c-8faf-e063-6394a90ab4bd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0042279802046"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298228"], "spl_set_id": ["896a5443-e3d2-4af7-9e27-f1c1899ce038"], "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": "1 BOTTLE in 1 CARTON (53145-322-04)  / 120 mL in 1 BOTTLE", "package_ndc": "53145-322-04", "marketing_start_date": "20100118"}], "brand_name": "Bisolvine Children", "product_id": "53145-322_3a8ae821-335c-8faf-e063-6394a90ab4bd", "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": "53145-322", "generic_name": "Guaifenesin, Dextromethorphan", "labeler_name": "MENPER DISTRIBUTORS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bisolvine", "brand_name_suffix": "Children", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20100118", "listing_expiration_date": "20261231"}