tussin dm sugar free (82568-0015)

Drug Facts

Product Profile

Brand Name tussin dm sugar free

Generic Name dextromethorphan hbr and guaifenesin

Labeler aarna usa, inc.

Dosage Form LIQUID

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 20 mg/10mL, guaifenesin 200 mg/10mL

Manufacturer

AARNA USA, Inc.

Identifiers & Regulatory

Product NDC 82568-0015

Product ID 82568-0015_3542902c-eced-8c3a-e063-6294a90a490b

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2025-02-18

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 825680015

Hyphenated Format 82568-0015

Supplemental Identifiers

RxCUI

996520

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 tussin dm sugar free (source: ndc)

Generic Name dextromethorphan hbr and guaifenesin (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

20 mg/10mL
200 mg/10mL

source: ndc

Packaging

1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-4) / 118 mL in 1 BOTTLE, PLASTIC
473 mL in 1 BOTTLE, PLASTIC (82568-0015-6)
1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-8) / 236 mL in 1 BOTTLE, PLASTIC

source: ndc

Packages (3)

82568-0015-4 1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-4) / 118 mL in 1 BOTTLE, PLASTIC 82568-0015-6 473 mL in 1 BOTTLE, PLASTIC (82568-0015-6) 82568-0015-8 1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-8) / 236 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (20 mg/10mL) guaifenesin (200 mg/10mL)

Linked Drug Pages (1)

Tussin DM Sugar free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "3542902c-eced-8c3a-e063-6294a90a490b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["3a521b65-fb35-4cc3-b826-88513afda0f9"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["AARNA USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-4)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82568-0015-4", "marketing_start_date": "20250218"}, {"sample": false, "description": "473 mL in 1 BOTTLE, PLASTIC (82568-0015-6)", "package_ndc": "82568-0015-6", "marketing_start_date": "20250218"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (82568-0015-8)  / 236 mL in 1 BOTTLE, PLASTIC", "package_ndc": "82568-0015-8", "marketing_start_date": "20250218"}], "brand_name": "Tussin DM Sugar free", "product_id": "82568-0015_3542902c-eced-8c3a-e063-6294a90a490b", "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": "82568-0015", "generic_name": "Dextromethorphan HBr and Guaifenesin", "labeler_name": "AARNA USA, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tussin DM Sugar free", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/10mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250218", "listing_expiration_date": "20261231"}