defensol-ito

Generic: dextromethorphan, guiafenesin, phenylephrine

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

Drug Facts

Product Profile

Brand Name defensol-ito
Generic Name dextromethorphan, guiafenesin, phenylephrine
Labeler menper distributors, inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 4 mg/mL, guaifenesin 50 mg/mL, phenylephrine hydrochloride 2.5 mg/mL

Manufacturer
Menper Distributors, Inc

Identifiers & Regulatory

Product NDC 53145-333
Product ID 53145-333_3a8ae61d-30c1-903c-e063-6394a90ae5c2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-01-01

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 53145333
Hyphenated Format 53145-333

Supplemental Identifiers

RxCUI
1661314
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
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-ito (source: ndc)
Generic Name dextromethorphan, guiafenesin, phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
  • 50 mg/mL
  • 2.5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) / 30 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

53145-333-15 1 BOTTLE, DROPPER in 1 CARTON (53145-333-15) / 30 mL in 1 BOTTLE, DROPPER

Ingredients (3)

dextromethorphan hydrobromide (4 mg/mL) guaifenesin (50 mg/mL) phenylephrine hydrochloride (2.5 mg/mL)

Linked Drug Pages (1)

Defensol-ito ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a8ae61d-30c1-903c-e063-6394a90ae5c2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1661314"], "spl_set_id": ["a7c7a60d-d49f-4239-92f7-714eac7eb0c5"], "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, DROPPER in 1 CARTON (53145-333-15)  / 30 mL in 1 BOTTLE, DROPPER", "package_ndc": "53145-333-15", "marketing_start_date": "20140101"}], "brand_name": "Defensol-ito", "product_id": "53145-333_3a8ae61d-30c1-903c-e063-6394a90ae5c2", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53145-333", "generic_name": "Dextromethorphan, Guiafenesin, Phenylephrine", "labeler_name": "Menper Distributors, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Defensol-ito", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "4 mg/mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140101", "listing_expiration_date": "20261231"}