nighttime cold and flu relief

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

Labeler: family dollar (family wellness)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime cold and flu relief
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler family dollar (family wellness)
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 15 mg/1, doxylamine succinate 6.25 mg/1

Manufacturer
Family Dollar (FAMILY WELLNESS)

Identifiers & Regulatory

Product NDC 55319-968
Product ID 55319-968_cebc5823-181f-43d2-8c3f-ef874ea6b5f9
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

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 55319968
Hyphenated Format 55319-968

Supplemental Identifiers

RxCUI
1094549
UPC
0032251920967
UNII
362O9ITL9D 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 cold and flu relief (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 15 mg/1
  • 6.25 mg/1
source: ndc
Packaging
  • 8 BLISTER PACK in 1 CARTON (55319-968-08) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 16 BLISTER PACK in 1 CARTON (55319-968-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 24 BLISTER PACK in 1 CARTON (55319-968-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (3)

55319-968-08 8 BLISTER PACK in 1 CARTON (55319-968-08) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 55319-968-16 16 BLISTER PACK in 1 CARTON (55319-968-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 55319-968-24 24 BLISTER PACK in 1 CARTON (55319-968-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (15 mg/1) doxylamine succinate (6.25 mg/1)

Linked Drug Pages (1)

Nighttime Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cebc5823-181f-43d2-8c3f-ef874ea6b5f9", "openfda": {"upc": ["0032251920967"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1094549"], "spl_set_id": ["2c431220-c61b-4ad5-9ad2-58ccaee2d1c3"], "manufacturer_name": ["Family Dollar (FAMILY WELLNESS)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 BLISTER PACK in 1 CARTON (55319-968-08)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "55319-968-08", "marketing_start_date": "20230701"}, {"sample": false, "description": "16 BLISTER PACK in 1 CARTON (55319-968-16)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "55319-968-16", "marketing_start_date": "20230701"}, {"sample": false, "description": "24 BLISTER PACK in 1 CARTON (55319-968-24)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "55319-968-24", "marketing_start_date": "20230701"}], "brand_name": "Nighttime Cold and Flu Relief", "product_id": "55319-968_cebc5823-181f-43d2-8c3f-ef874ea6b5f9", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "55319-968", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE", "labeler_name": "Family Dollar (FAMILY WELLNESS)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Nighttime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}