nighttime cough dm

Generic: dextromethorphan hbr, doxylamine succinate

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cough dm
Generic Name dextromethorphan hbr, doxylamine succinate
Labeler l.n.k. international, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 30 mg/20mL, doxylamine succinate 12.5 mg/20mL

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-043
Product ID 50844-043_6e134af4-fc35-4cad-a9f0-047520f43506
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2021-07-16

Pharmacologic Class

Classes
antihistamine [epc] histamine receptor antagonists [moa] sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50844043
Hyphenated Format 50844-043

Supplemental Identifiers

RxCUI
1115329
UPC
0350844043368
UNII
9D2RTI9KYH V9BI9B5YI2

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 nighttime cough dm (source: ndc)
Generic Name dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/20mL
  • 12.5 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (50844-043-36) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

50844-043-36 1 BOTTLE, PLASTIC in 1 CARTON (50844-043-36) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (30 mg/20mL) doxylamine succinate (12.5 mg/20mL)

Linked Drug Pages (1)

Nighttime Cough DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6e134af4-fc35-4cad-a9f0-047520f43506", "openfda": {"upc": ["0350844043368"], "unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1115329"], "spl_set_id": ["75a9c736-bc7e-4b7f-84ea-9474a37508ec"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (50844-043-36)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "50844-043-36", "marketing_start_date": "20210716"}], "brand_name": "Nighttime Cough DM", "product_id": "50844-043_6e134af4-fc35-4cad-a9f0-047520f43506", "dosage_form": "SOLUTION", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "50844-043", "generic_name": "Dextromethorphan HBr, Doxylamine Succinate", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cough DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/20mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210716", "listing_expiration_date": "20261231"}