night time cough

Generic: dextromethorphan hydrobromide, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name night time cough
Generic Name dextromethorphan hydrobromide, doxylamine succinate
Labeler safeway, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Safeway, Inc.

Identifiers & Regulatory

Product NDC 21130-499
Product ID 21130-499_fe3d9fc3-fb69-4c27-9c5f-e356968d046f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-01-31

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 21130499
Hyphenated Format 21130-499

Supplemental Identifiers

RxCUI
1234386
UPC
0321130763369
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 night time 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/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 355 mL in 1 BOTTLE, PLASTIC (21130-499-12)
source: ndc

Packages (1)

21130-499-12 355 mL in 1 BOTTLE, PLASTIC (21130-499-12)

Ingredients (2)

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

Linked Drug Pages (1)

Night Time Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe3d9fc3-fb69-4c27-9c5f-e356968d046f", "openfda": {"upc": ["0321130763369"], "unii": ["9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1234386"], "spl_set_id": ["f658a03b-6fc2-4b63-b3ab-7e886fbf20b4"], "manufacturer_name": ["Safeway, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (21130-499-12)", "package_ndc": "21130-499-12", "marketing_start_date": "20180131"}], "brand_name": "Night Time Cough", "product_id": "21130-499_fe3d9fc3-fb69-4c27-9c5f-e356968d046f", "dosage_form": "LIQUID", "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": "21130-499", "generic_name": "Dextromethorphan Hydrobromide, Doxylamine Succinate", "labeler_name": "Safeway, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Night Time Cough", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180131", "listing_expiration_date": "20261231"}