cold and flu relief daytime

Generic: acetaminohpen, dextromethorphan hbr, phenylephrine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cold and flu relief daytime
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl
Labeler major pharmaceuticals
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6995
Product ID 0904-6995_09989162-8570-4ac9-8f3e-30ec3ee76b77
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-07-31

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 09046995
Hyphenated Format 0904-6995

Supplemental Identifiers

RxCUI
1086997
UPC
0309046995449
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 cold and flu relief daytime (source: ndc)
Generic Name acetaminohpen, dextromethorphan hbr, phenylephrine hcl (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
  • 16 BLISTER PACK in 1 CARTON (0904-6995-44) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-6995-44 16 BLISTER PACK in 1 CARTON (0904-6995-44) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Cold and Flu Relief Daytime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "09989162-8570-4ac9-8f3e-30ec3ee76b77", "openfda": {"upc": ["0309046995449"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1086997"], "spl_set_id": ["6c11c8c8-b2e1-4b9e-80cf-23247c03dd9b"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 BLISTER PACK in 1 CARTON (0904-6995-44)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0904-6995-44", "marketing_start_date": "20190731"}], "brand_name": "Cold and Flu Relief Daytime", "product_id": "0904-6995_09989162-8570-4ac9-8f3e-30ec3ee76b77", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "0904-6995", "generic_name": "ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cold and Flu Relief", "brand_name_suffix": "Daytime", "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": "20190731", "listing_expiration_date": "20261231"}