g-zyncof

Generic: dextromethorphan hbr and guaifenesin

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name g-zyncof
Generic Name dextromethorphan hbr and guaifenesin
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, guaifenesin 400 mg/5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-600
Product ID 52083-600_a7c507ab-f326-4890-b26d-d80c59cacf8a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-12-03

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 52083600
Hyphenated Format 52083-600

Supplemental Identifiers

RxCUI
1113368
UPC
0352083600166
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 g-zyncof (source: ndc)
Generic Name dextromethorphan hbr and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 400 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (52083-600-16)
source: ndc

Packages (1)

52083-600-16 473 mL in 1 BOTTLE, PLASTIC (52083-600-16)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/5mL) guaifenesin (400 mg/5mL)

Linked Drug Pages (1)

G-ZYNCOF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a7c507ab-f326-4890-b26d-d80c59cacf8a", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083600166"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1113368"], "spl_set_id": ["c1aa7060-0f32-4ea1-8e2e-1aa131bd55fc"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (52083-600-16)", "package_ndc": "52083-600-16", "marketing_start_date": "20121203"}], "brand_name": "G-ZYNCOF", "product_id": "52083-600_a7c507ab-f326-4890-b26d-d80c59cacf8a", "dosage_form": "SYRUP", "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": "52083-600", "generic_name": "Dextromethorphan HBr and Guaifenesin", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "G-ZYNCOF", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20121203", "listing_expiration_date": "20261231"}