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 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 52083-400
Product ID 52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-06-01

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 52083400
Hyphenated Format 52083-400

Supplemental Identifiers

RxCUI
1113368
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 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
  • 30 mL in 1 BOTTLE, PLASTIC (52083-400-01)
  • 120 mL in 1 BOTTLE, PLASTIC (52083-400-04)
  • 474 mL in 1 BOTTLE, PLASTIC (52083-400-16)
source: ndc

Packages (3)

52083-400-01 30 mL in 1 BOTTLE, PLASTIC (52083-400-01) 52083-400-04 120 mL in 1 BOTTLE, PLASTIC (52083-400-04) 52083-400-16 474 mL in 1 BOTTLE, PLASTIC (52083-400-16)

Ingredients (2)

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

Linked Drug Pages (1)

ZYNCOF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7e831d13-64c5-4ee2-a290-d1d93ceec80f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1113368"], "spl_set_id": ["cffd6d5f-0cb2-4d38-bdb0-6a21120418cc"], "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": "30 mL in 1 BOTTLE, PLASTIC (52083-400-01)", "package_ndc": "52083-400-01", "marketing_start_date": "20110601"}, {"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (52083-400-04)", "package_ndc": "52083-400-04", "marketing_start_date": "20110601"}, {"sample": false, "description": "474 mL in 1 BOTTLE, PLASTIC (52083-400-16)", "package_ndc": "52083-400-16", "marketing_start_date": "20130123"}], "brand_name": "ZYNCOF", "product_id": "52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f", "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": "52083-400", "generic_name": "Dextromethorphan HBr and Guaifenesin", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "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": "20110601", "listing_expiration_date": "20261231"}