daytime cold and flu

Generic: acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime cold and flu
Generic Name acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg
Labeler allegiant health
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

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

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-417
Product ID 69168-417_c2498c7c-a983-4ee4-b796-e0f844c9fcd0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-11-11

Pharmacologic Class

Classes
adrenergic alpha1-agonists [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 69168417
Hyphenated Format 69168-417

Supplemental Identifiers

RxCUI
1086997
UNII
362O9ITL9D 9D2RTI9KYH 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 daytime cold and flu (source: ndc)
Generic Name acetaminophen 325mg/ dextromethorphan hbr 10mg/ phenylephrine hcl 5mg (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 10 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 8 CAPSULE in 1 BLISTER PACK (69168-417-29)
  • 2 BLISTER PACK in 1 CARTON (69168-417-51) / 10 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

69168-417-29 8 CAPSULE in 1 BLISTER PACK (69168-417-29) 69168-417-51 2 BLISTER PACK in 1 CARTON (69168-417-51) / 10 CAPSULE in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Daytime Cold and Flu ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c2498c7c-a983-4ee4-b796-e0f844c9fcd0", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["bed5f9dc-45ea-4e90-86c6-86599b6f3861"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 CAPSULE in 1 BLISTER PACK (69168-417-29)", "package_ndc": "69168-417-29", "marketing_start_date": "20201111"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69168-417-51)  / 10 CAPSULE in 1 BLISTER PACK", "package_ndc": "69168-417-51", "marketing_start_date": "20201111"}], "brand_name": "Daytime Cold and Flu", "product_id": "69168-417_c2498c7c-a983-4ee4-b796-e0f844c9fcd0", "dosage_form": "CAPSULE", "pharm_class": ["Adrenergic alpha1-Agonists [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": "69168-417", "generic_name": "Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201111", "listing_expiration_date": "20261231"}