onessip adult nighttime severe cold and flu

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

Labeler: medwise lifesciences inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name onessip adult nighttime severe cold and flu
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hci
Labeler medwise lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/15mL, dextromethorphan hydrobromide 20 mg/15mL, doxylamine succinate 12.5 mg/15mL, phenylephrine hydrochloride 10 mg/15mL

Manufacturer
MEDWISE LIFESCIENCES INC.

Identifiers & Regulatory

Product NDC 87078-872
Product ID 87078-872_4970b8dd-9342-59a3-e063-6294a90a3a8d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2026-01-28

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 87078872
Hyphenated Format 87078-872

Supplemental Identifiers

RxCUI
2733907
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 onessip adult nighttime severe cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/15mL
  • 20 mg/15mL
  • 12.5 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (87078-872-32) / 15 mL in 1 POUCH (87078-872-03)
source: ndc

Packages (1)

87078-872-32 12 POUCH in 1 CARTON (87078-872-32) / 15 mL in 1 POUCH (87078-872-03)

Ingredients (4)

acetaminophen (650 mg/15mL) dextromethorphan hydrobromide (20 mg/15mL) doxylamine succinate (12.5 mg/15mL) phenylephrine hydrochloride (10 mg/15mL)

Linked Drug Pages (1)

ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4970b8dd-9342-59a3-e063-6294a90a3a8d", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2", "04JA59TNSJ"], "rxcui": ["2733907"], "spl_set_id": ["4970b8bc-3c7b-4b8a-e063-6294a90a7f1b"], "manufacturer_name": ["MEDWISE LIFESCIENCES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (87078-872-32)  / 15 mL in 1 POUCH (87078-872-03)", "package_ndc": "87078-872-32", "marketing_start_date": "20260128"}], "brand_name": "ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU", "product_id": "87078-872_4970b8dd-9342-59a3-e063-6294a90a3a8d", "dosage_form": "SOLUTION", "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": "87078-872", "generic_name": "Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCI", "labeler_name": "MEDWISE LIFESCIENCES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ONESSIP ADULT NIGHTTIME SEVERE COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/15mL"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "12.5 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20260128", "listing_expiration_date": "20271231"}