nighttime severe cold and flu

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl

Labeler: kroger
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name nighttime severe cold and flu
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Labeler kroger
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, dextromethorphan hydrobromide 10 mg/1, doxylamine succinate 6.25 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
KROGER

Identifiers & Regulatory

Product NDC 41226-626
Product ID 41226-626_4716c052-0f4a-2d90-e063-6294a90a9a56
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-05-29

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 41226626
Hyphenated Format 41226-626

Supplemental Identifiers

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

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 6.25 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-626-08)
source: ndc

Packages (1)

41226-626-08 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-626-08)

Ingredients (4)

acetaminophen (325 mg/1) dextromethorphan hydrobromide (10 mg/1) doxylamine succinate (6.25 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

NIGHTTIME SEVERE COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4716c052-0f4a-2d90-e063-6294a90a9a56", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "spl_set_id": ["a690f5c5-ff41-4072-e053-2995a90a8e55"], "manufacturer_name": ["KROGER"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (41226-626-08)", "package_ndc": "41226-626-08", "marketing_start_date": "20201116"}], "brand_name": "NIGHTTIME SEVERE COLD AND FLU", "product_id": "41226-626_4716c052-0f4a-2d90-e063-6294a90a9a56", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "41226-626", "generic_name": "ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL", "labeler_name": "KROGER", "product_type": "HUMAN OTC DRUG", "brand_name_base": "NIGHTTIME SEVERE COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200529", "listing_expiration_date": "20261231"}