night time cold and flu readyincase

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate

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

Drug Facts

Product Profile

Brand Name night time cold and flu readyincase
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0343
Product ID 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Marketing Start 2014-10-31
Marketing End 2026-12-31

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 495800343
Hyphenated Format 49580-0343

Supplemental Identifiers

RxCUI
1043400
UPC
0349580343061
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 night time cold and flu readyincase (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, 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
  • 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2)
  • 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4)
  • 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6)
  • 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8)
source: ndc

Packages (4)

49580-0343-2 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2) 49580-0343-4 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4) 49580-0343-6 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6) 49580-0343-8 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8)

Ingredients (3)

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

Linked Drug Pages (1)

Night Time Cold and Flu ReadyInCase ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e", "openfda": {"upc": ["0349580343061"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1043400"], "spl_set_id": ["e7dd763b-3005-4723-933b-171eb772afee"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "355 mL in 1 BOTTLE, PLASTIC (49580-0343-2)", "package_ndc": "49580-0343-2", "marketing_end_date": "20261231", "marketing_start_date": "20141031"}, {"sample": false, "description": "118 mL in 1 BOTTLE, PLASTIC (49580-0343-4)", "package_ndc": "49580-0343-4", "marketing_end_date": "20261231", "marketing_start_date": "20141031"}, {"sample": false, "description": "177 mL in 1 BOTTLE, PLASTIC (49580-0343-6)", "package_ndc": "49580-0343-6", "marketing_end_date": "20261231", "marketing_start_date": "20141031"}, {"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (49580-0343-8)", "package_ndc": "49580-0343-8", "marketing_end_date": "20261231", "marketing_start_date": "20141031"}], "brand_name": "Night Time Cold and Flu ReadyInCase", "product_id": "49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4e", "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": "49580-0343", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Night Time Cold and Flu", "brand_name_suffix": "ReadyInCase", "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_end_date": "20261231", "marketing_start_date": "20141031"}