desgen dm

Generic: dextromethorphan hbr ,guaifenesin ,phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name desgen dm
Generic Name dextromethorphan hbr ,guaifenesin ,phenylephrine hcl
Labeler kramer novis
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL, phenylephrine hydrochloride 5 mg/5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-646
Product ID 52083-646_affd083a-31b7-4862-ac14-e4ccc4d2ca7e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-10-18

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 52083646
Hyphenated Format 52083-646

Supplemental Identifiers

RxCUI
1044949
UPC
0352083646164
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 desgen dm (source: ndc)
Generic Name dextromethorphan hbr ,guaifenesin ,phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 474 mL in 1 BOTTLE (52083-646-16)
source: ndc

Packages (1)

52083-646-16 474 mL in 1 BOTTLE (52083-646-16)

Ingredients (3)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL) phenylephrine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

DESGEN DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "affd083a-31b7-4862-ac14-e4ccc4d2ca7e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0352083646164"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1044949"], "spl_set_id": ["6ab47174-e1fd-47ce-8788-06b7cdad5218"], "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": "474 mL in 1 BOTTLE (52083-646-16)", "package_ndc": "52083-646-16", "marketing_start_date": "20141018"}], "brand_name": "DESGEN DM", "product_id": "52083-646_affd083a-31b7-4862-ac14-e4ccc4d2ca7e", "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": "52083-646", "generic_name": "Dextromethorphan HBr ,Guaifenesin ,Phenylephrine HCl", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DESGEN DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20141018", "listing_expiration_date": "20261231"}