defensol adult syrup

Generic: guaifenesin, dextromethorphan hbr

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

Drug Facts

Product Profile

Brand Name defensol adult syrup
Generic Name guaifenesin, dextromethorphan hbr
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 53145-039
Product ID 53145-039_3a89a0df-993d-f0d7-e063-6394a90a1c8b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-02-21

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 53145039
Hyphenated Format 53145-039

Supplemental Identifiers

RxCUI
996520
UPC
0042279426044
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 defensol adult syrup (source: ndc)
Generic Name guaifenesin, dextromethorphan hbr (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/10mL
  • 200 mg/10mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53145-039-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

53145-039-04 1 BOTTLE in 1 CARTON (53145-039-04) / 120 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Defensol Adult Syrup ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a89a0df-993d-f0d7-e063-6394a90a1c8b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0042279426044"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["62acff69-8c40-4a0e-8d56-be2cc14e3d45"], "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 (53145-039-04)  / 120 mL in 1 BOTTLE", "package_ndc": "53145-039-04", "marketing_start_date": "20120221"}], "brand_name": "Defensol Adult Syrup", "product_id": "53145-039_3a89a0df-993d-f0d7-e063-6394a90a1c8b", "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": "53145-039", "generic_name": "Guaifenesin, Dextromethorphan HBR", "labeler_name": "Menper Distributors, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Defensol Adult Syrup", "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": "20120221", "listing_expiration_date": "20261231"}