tusslin

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride

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

Drug Facts

Product Profile

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

dextromethorphan hydrobromide 20 mg/5mL, guaifenesin 388 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-624
Product ID 52083-624_2d816a62-defd-4fa4-8809-73fb009e0394
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-03

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 52083624
Hyphenated Format 52083-624

Supplemental Identifiers

RxCUI
2728493
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 tusslin (source: ndc)
Generic Name dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 388 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE, PLASTIC (52083-624-16)
source: ndc

Packages (1)

52083-624-16 473 mL in 1 BOTTLE, PLASTIC (52083-624-16)

Ingredients (3)

dextromethorphan hydrobromide (20 mg/5mL) guaifenesin (388 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

TUSSLIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d816a62-defd-4fa4-8809-73fb009e0394", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["2728493"], "spl_set_id": ["987e19a5-032f-44e9-b4c7-8a764d502695"], "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 (52083-624-16)", "package_ndc": "52083-624-16", "marketing_start_date": "20251203"}], "brand_name": "TUSSLIN", "product_id": "52083-624_2d816a62-defd-4fa4-8809-73fb009e0394", "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": "52083-624", "generic_name": "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TUSSLIN", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "388 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251203", "listing_expiration_date": "20261231"}