severe nighttime cold and flu relief

Generic: acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hci

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

Drug Facts

Product Profile

Brand Name severe nighttime cold and flu relief
Generic Name acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hci
Labeler family dollar (family wellness)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, doxylamine succinate 12.5 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
Family Dollar (FAMILY WELLNESS)

Identifiers & Regulatory

Product NDC 55319-641
Product ID 55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55319641
Hyphenated Format 55319-641

Supplemental Identifiers

RxCUI
1431245
UPC
0032251141188
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 04JA59TNSJ

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 severe nighttime cold and flu relief (source: ndc)
Generic Name acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 12.5 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (55319-641-08)
source: ndc

Packages (1)

55319-641-08 237 mL in 1 BOTTLE, PLASTIC (55319-641-08)

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) doxylamine succinate (12.5 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Severe Nighttime Cold and Flu Relief ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b135042b-47eb-4018-8fdb-6e1b7d5a214c", "openfda": {"upc": ["0032251141188"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["e5c90d6e-70aa-4886-bc81-293e0dcf5638"], "manufacturer_name": ["Family Dollar (FAMILY WELLNESS)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (55319-641-08)", "package_ndc": "55319-641-08", "marketing_start_date": "20240731"}], "brand_name": "Severe Nighttime Cold and Flu Relief", "product_id": "55319-641_b135042b-47eb-4018-8fdb-6e1b7d5a214c", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "55319-641", "generic_name": "Acetaminophen Dextromethorphan HBr Doxylamine Succinate Phenylephrine HCI", "labeler_name": "Family Dollar (FAMILY WELLNESS)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe Nighttime Cold and Flu Relief", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240731", "listing_expiration_date": "20261231"}