xl-3 night time

Generic: acetaminophen, dextromethorphan hbr, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name xl-3 night time
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate
Labeler rnv llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 30 mg/30mL, doxylamine succinate 12.5 mg/30mL

Manufacturer
Rnv LLC

Identifiers & Regulatory

Product NDC 84379-444
Product ID 84379-444_49634dc2-a45b-f42b-e063-6294a90ade9c
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
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84379444
Hyphenated Format 84379-444

Supplemental Identifiers

RxCUI
1043400
UPC
0645981000351 0645981000290
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2

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 night time (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 30 mg/30mL
  • 12.5 mg/30mL
source: ndc
Packaging
  • 177 mL in 1 BOTTLE (84379-444-06)
  • 354 mL in 1 BOTTLE (84379-444-12)
source: ndc

Packages (2)

84379-444-06 177 mL in 1 BOTTLE (84379-444-06) 84379-444-12 354 mL in 1 BOTTLE (84379-444-12)

Ingredients (3)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (30 mg/30mL) doxylamine succinate (12.5 mg/30mL)

Linked Drug Pages (1)

XL-3 Night Time ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "49634dc2-a45b-f42b-e063-6294a90ade9c", "openfda": {"upc": ["0645981000351", "0645981000290"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["03210929-331e-462d-b566-4e1865f52246"], "manufacturer_name": ["Rnv LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "177 mL in 1 BOTTLE (84379-444-06)", "package_ndc": "84379-444-06", "marketing_start_date": "20241201"}, {"sample": false, "description": "354 mL in 1 BOTTLE (84379-444-12)", "package_ndc": "84379-444-12", "marketing_start_date": "20241201"}], "brand_name": "XL-3 Night Time", "product_id": "84379-444_49634dc2-a45b-f42b-e063-6294a90ade9c", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "84379-444", "generic_name": "acetaminophen, dextromethorphan HBr, Doxylamine Succinate", "labeler_name": "Rnv LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "XL-3 Night Time", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241201", "listing_expiration_date": "20271231"}