giltuss diabetic

Generic: dextromethorphan hydrobromide, guaifenesin

Labeler: dextrum laboratories, inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss diabetic
Generic Name dextromethorphan hydrobromide, guaifenesin
Labeler dextrum laboratories, inc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Dextrum Laboratories, Inc

Identifiers & Regulatory

Product NDC 65852-009
Product ID 65852-009_40806093-e562-0be7-e063-6294a90a949c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-10-17

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 65852009
Hyphenated Format 65852-009

Supplemental Identifiers

RxCUI
996520
UNII
351KFH969D 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 giltuss diabetic (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin (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, PLASTIC in 1 CARTON (65852-009-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-009-04 1 BOTTLE, PLASTIC in 1 CARTON (65852-009-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Giltuss Diabetic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "40806093-e562-0be7-e063-6294a90a949c", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["351KFH969D", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["3f64c81a-bbfc-4575-e063-6294a90a6ed7"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dextrum Laboratories, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-009-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-009-04", "marketing_start_date": "20181017"}], "brand_name": "Giltuss Diabetic", "product_id": "65852-009_40806093-e562-0be7-e063-6294a90a949c", "dosage_form": "SOLUTION", "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": "65852-009", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin", "labeler_name": "Dextrum Laboratories, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Diabetic", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROCHLORIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181017", "listing_expiration_date": "20261231"}