mucus relief dm extended release caplets (70000-0464)

Drug Facts

Product Profile

Brand Name mucus relief dm extended release caplets

Generic Name guaifenesin, dextromethorphan hbr

Labeler cardinal health (leader) 70000

Dosage Form TABLET

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 60 mg/1, guaifenesin 1200 mg/1

Manufacturer

Cardinal Health (Leader) 70000

Identifiers & Regulatory

Product NDC 70000-0464

Product ID 70000-0464_55dad94f-71e8-4e1e-bd70-520033e6d8cd

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA209692

Listing Expiration 2026-12-31

Marketing Start 2018-12-31

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 700000464

Hyphenated Format 70000-0464

Supplemental Identifiers

RxCUI

1099074

UPC

0096295136500

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 mucus relief dm extended release caplets (source: ndc)

Generic Name guaifenesin, dextromethorphan hbr (source: ndc)

Application Number ANDA209692 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

60 mg/1
1200 mg/1

source: ndc

Packaging

28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK
14 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK

source: ndc

Packages (2)

70000-0464-1 28 BLISTER PACK in 1 CARTON (70000-0464-1) / 1 TABLET in 1 BLISTER PACK 70000-0464-2 14 BLISTER PACK in 1 CARTON (70000-0464-2) / 1 TABLET in 1 BLISTER PACK

Ingredients (2)

dextromethorphan hydrobromide (60 mg/1) guaifenesin (1200 mg/1)

Linked Drug Pages (1)

Mucus Relief DM Extended Release Caplets ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "55dad94f-71e8-4e1e-bd70-520033e6d8cd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0096295136500"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1099074"], "spl_set_id": ["04af43e6-6276-42ec-a902-3de22bc9fdea"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Cardinal Health (Leader) 70000"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 BLISTER PACK in 1 CARTON (70000-0464-1)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0464-1", "marketing_start_date": "20181231"}, {"sample": false, "description": "14 BLISTER PACK in 1 CARTON (70000-0464-2)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "70000-0464-2", "marketing_start_date": "20181231"}], "brand_name": "Mucus Relief DM Extended Release Caplets", "product_id": "70000-0464_55dad94f-71e8-4e1e-bd70-520033e6d8cd", "dosage_form": "TABLET", "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": "70000-0464", "generic_name": "Guaifenesin, Dextromethorphan HBr", "labeler_name": "Cardinal Health (Leader) 70000", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Mucus Relief DM Extended Release Caplets", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "60 mg/1"}, {"name": "GUAIFENESIN", "strength": "1200 mg/1"}], "application_number": "ANDA209692", "marketing_category": "ANDA", "marketing_start_date": "20181231", "listing_expiration_date": "20261231"}