sda laboratories tussin dm

Generic: dextromethorphan hbr, guaifenesin

Labeler: sda laboratories, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name sda laboratories tussin dm
Generic Name dextromethorphan hbr, guaifenesin
Labeler sda laboratories, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
SDA Laboratories, Inc.

Identifiers & Regulatory

Product NDC 66424-565
Product ID 66424-565_2a446fca-4094-b70a-e063-6294a90a7d2e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

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 66424565
Hyphenated Format 66424-565

Supplemental Identifiers

RxCUI
996520
UPC
0366424565168
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 sda laboratories tussin dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (66424-565-16)
source: ndc

Packages (1)

66424-565-16 473 mL in 1 BOTTLE (66424-565-16)

Ingredients (2)

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

Linked Drug Pages (1)

SDA Laboratories Tussin DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a446fca-4094-b70a-e063-6294a90a7d2e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0366424565168"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["2a445f31-818d-11b1-e063-6294a90a8cb1"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["SDA Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (66424-565-16)", "package_ndc": "66424-565-16", "marketing_start_date": "20241201"}], "brand_name": "SDA Laboratories Tussin DM", "product_id": "66424-565_2a446fca-4094-b70a-e063-6294a90a7d2e", "dosage_form": "LIQUID", "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": "66424-565", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "SDA Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SDA Laboratories Tussin DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}