xl-3 day time

Generic: acetaminophen, dextromethorphan hbr, phenylephrine hcl

Labeler: rnv llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name xl-3 day time
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl
Labeler rnv llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
Rnv LLC

Identifiers & Regulatory

Product NDC 84379-441
Product ID 84379-441_49635108-cf29-a6d3-e063-6394a90a9df0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-12-01

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 84379441
Hyphenated Format 84379-441

Supplemental Identifiers

RxCUI
1113705
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 xl-3 day time (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, phenylephrine hcl (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
  • 177 mL in 1 BOTTLE (84379-441-06)
  • 354 mL in 1 BOTTLE (84379-441-12)
source: ndc

Packages (2)

84379-441-06 177 mL in 1 BOTTLE (84379-441-06) 84379-441-12 354 mL in 1 BOTTLE (84379-441-12)

Ingredients (3)

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

Linked Drug Pages (1)

XL-3 Day Time ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49635108-cf29-a6d3-e063-6394a90a9df0", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113705"], "spl_set_id": ["2381ff41-4584-4b38-839f-f94e733f5bf2"], "manufacturer_name": ["Rnv LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (84379-441-06)", "package_ndc": "84379-441-06", "marketing_start_date": "20241201"}, {"sample": false, "description": "354 mL in 1 BOTTLE (84379-441-12)", "package_ndc": "84379-441-12", "marketing_start_date": "20241201"}], "brand_name": "XL-3 Day Time", "product_id": "84379-441_49635108-cf29-a6d3-e063-6394a90a9df0", "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": "84379-441", "generic_name": "acetaminophen, dextromethorphan HBr, Phenylephrine HCl", "labeler_name": "Rnv LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "XL-3 Day Time", "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_start_date": "20241201", "listing_expiration_date": "20271231"}