daytime cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride

Labeler: p & l development, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name daytime cold and flu
Generic Name acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0466
Product ID 49580-0466_a89992d4-6dd6-4a8c-8b3a-3fc1b63a1e75
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2015-06-30
Marketing End 2027-01-30

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 495800466
Hyphenated Format 49580-0466

Supplemental Identifiers

RxCUI
1113705
UPC
0349580466401
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, dextromethorphan hydrobromide, phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/15mL
  • 10 mg/15mL
  • 5 mg/15mL
source: ndc
Packaging
  • 296 mL in 1 BOTTLE, PLASTIC (49580-0466-1)
  • 355 mL in 1 BOTTLE, PLASTIC (49580-0466-2)
  • 118 mL in 1 BOTTLE, PLASTIC (49580-0466-4)
  • 177 mL in 1 BOTTLE, PLASTIC (49580-0466-6)
source: ndc

Packages (4)

49580-0466-1 296 mL in 1 BOTTLE, PLASTIC (49580-0466-1) 49580-0466-2 355 mL in 1 BOTTLE, PLASTIC (49580-0466-2) 49580-0466-4 118 mL in 1 BOTTLE, PLASTIC (49580-0466-4) 49580-0466-6 177 mL in 1 BOTTLE, PLASTIC (49580-0466-6)

Ingredients (3)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

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": "a89992d4-6dd6-4a8c-8b3a-3fc1b63a1e75", "openfda": {"upc": ["0349580466401"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["0bb006f6-c360-4cd5-81e9-0776d99d79e8"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "296 mL in 1 BOTTLE, PLASTIC (49580-0466-1)", "package_ndc": "49580-0466-1", "marketing_end_date": "20270130", "marketing_start_date": "20150630"}, {"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (49580-0466-2)", "package_ndc": "49580-0466-2", "marketing_end_date": "20270130", "marketing_start_date": "20150630"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (49580-0466-4)", "package_ndc": "49580-0466-4", "marketing_end_date": "20270130", "marketing_start_date": "20150630"}, {"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49580-0466-6)", "package_ndc": "49580-0466-6", "marketing_end_date": "20270130", "marketing_start_date": "20150630"}], "brand_name": "Daytime Cold and Flu", "product_id": "49580-0466_a89992d4-6dd6-4a8c-8b3a-3fc1b63a1e75", "dosage_form": "LIQUID", "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": "49580-0466", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20270130", "marketing_start_date": "20150630"}