presgen

Generic: guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name presgen
Generic Name guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 200 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-632
Product ID 52083-632_c3363889-6ee4-4e45-9233-712513223055
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2011-03-28

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 52083632
Hyphenated Format 52083-632

Supplemental Identifiers

RxCUI
1098647
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 presgen (source: ndc)
Generic Name guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 200 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 480 mL in 1 BOTTLE (52083-632-16)
source: ndc

Packages (1)

52083-632-16 480 mL in 1 BOTTLE (52083-632-16)

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (200 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Presgen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c3363889-6ee4-4e45-9233-712513223055", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1098647"], "spl_set_id": ["edad7a86-0d27-4a98-85b2-4b6725904f28"], "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": "480 mL in 1 BOTTLE (52083-632-16)", "package_ndc": "52083-632-16", "marketing_start_date": "20110328"}], "brand_name": "Presgen", "product_id": "52083-632_c3363889-6ee4-4e45-9233-712513223055", "dosage_form": "SYRUP", "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": "52083-632", "generic_name": "guaifenesin, phenylephrine hydrochloride, dextromethorphan hydrobromide", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Presgen", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20110328", "listing_expiration_date": "20261231"}