severe cold and flu nighttime

Generic: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci

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

Drug Facts

Product Profile

Brand Name severe cold and flu nighttime
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci
Labeler p & l development, llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, doxylamine succinate 12.5 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
P & L Development, LLC

Identifiers & Regulatory

Product NDC 49580-0416
Product ID 49580-0416_46f4b7c3-c197-4717-8036-499652b0d716
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-08-31

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] 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] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 495800416
Hyphenated Format 49580-0416

Supplemental Identifiers

RxCUI
1431245
UPC
0349580416086
UNII
362O9ITL9D 9D2RTI9KYH V9BI9B5YI2 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 severe cold and flu nighttime (source: ndc)
Generic Name acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 12.5 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)
source: ndc

Packages (1)

49580-0416-8 237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) doxylamine succinate (12.5 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Severe cold and flu Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46f4b7c3-c197-4717-8036-499652b0d716", "openfda": {"upc": ["0349580416086"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["1431245"], "spl_set_id": ["7c92bdcf-db1f-4299-982f-6a3da9cba6e6"], "manufacturer_name": ["P & L Development, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (49580-0416-8)", "package_ndc": "49580-0416-8", "marketing_start_date": "20150831"}], "brand_name": "Severe cold and flu Nighttime", "product_id": "49580-0416_46f4b7c3-c197-4717-8036-499652b0d716", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "49580-0416", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine HCI", "labeler_name": "P & L Development, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Severe cold and flu", "brand_name_suffix": "Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150831", "listing_expiration_date": "20261231"}