nighttime cough

Generic: dextromethorphan hydrobromide, doxylamine succinate

Labeler: cvs woonsocket prescription center, incorporated
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cough
Generic Name dextromethorphan hydrobromide, doxylamine succinate
Labeler cvs woonsocket prescription center, incorporated
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Identifiers & Regulatory

Product NDC 51316-062
Product ID 51316-062_32dfa78b-f775-477f-a75f-98b5974b3386
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-06-12

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 51316062
Hyphenated Format 51316-062

Supplemental Identifiers

RxCUI
1115329
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 (source: ndc)
Generic Name dextromethorphan hydrobromide, 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 in 1 CARTON (51316-062-26) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

51316-062-26 1 BOTTLE in 1 CARTON (51316-062-26) / 118 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Nighttime Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "32dfa78b-f775-477f-a75f-98b5974b3386", "openfda": {"unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1115329"], "spl_set_id": ["45471fdd-c4cd-46ad-a932-aa37327e8a41"], "manufacturer_name": ["CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (51316-062-26)  / 118 mL in 1 BOTTLE", "package_ndc": "51316-062-26", "marketing_start_date": "20240612"}], "brand_name": "Nighttime Cough", "product_id": "51316-062_32dfa78b-f775-477f-a75f-98b5974b3386", "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": "51316-062", "generic_name": "Dextromethorphan Hydrobromide, Doxylamine succinate", "labeler_name": "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cough", "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": "20240612", "listing_expiration_date": "20261231"}