bisolvine aloe-miel

Generic: dextromethorphan, guaifenesin

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

Drug Facts

Product Profile

Brand Name bisolvine aloe-miel
Generic Name dextromethorphan, guaifenesin
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 53145-402
Product ID 53145-402_3a8afea2-5d9f-1392-e063-6294a90aca43
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-01-01

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 53145402
Hyphenated Format 53145-402

Supplemental Identifiers

RxCUI
1298228
UPC
0042279383040
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 aloe-miel (source: ndc)
Generic Name dextromethorphan, guaifenesin (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 (53145-402-06) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

53145-402-06 1 BOTTLE in 1 CARTON (53145-402-06) / 180 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Bisolvine Aloe-Miel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a8afea2-5d9f-1392-e063-6294a90aca43", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0042279383040"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1298228"], "spl_set_id": ["34801c79-ce88-492f-808e-b639e8601607"], "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 (53145-402-06)  / 180 mL in 1 BOTTLE", "package_ndc": "53145-402-06", "marketing_start_date": "20190101"}], "brand_name": "Bisolvine Aloe-Miel", "product_id": "53145-402_3a8afea2-5d9f-1392-e063-6294a90aca43", "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": "53145-402", "generic_name": "Dextromethorphan, Guaifenesin", "labeler_name": "MENPER DISTRIBUTORS INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Bisolvine", "brand_name_suffix": "Aloe-Miel", "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": "20190101", "listing_expiration_date": "20261231"}