onessip adult daytime severe cold and flu

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci

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

Drug Facts

Product Profile

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

acetaminophen 650 mg/15mL, dextromethorphan hydrobromide 20 mg/15mL, guaifenesin 400 mg/15mL, phenylephrine hydrochloride 10 mg/15mL

Manufacturer
MEDWISE LIFESCIENCES INC.

Identifiers & Regulatory

Product NDC 87078-972
Product ID 87078-972_45fa9159-d74d-063a-e063-6294a90a3ed0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2025-12-15

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 87078972
Hyphenated Format 87078-972

Supplemental Identifiers

UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

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 daytime severe cold and flu (source: ndc)
Generic Name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/15mL
  • 20 mg/15mL
  • 400 mg/15mL
  • 10 mg/15mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (87078-972-32) / 15 mL in 1 POUCH (87078-972-03)
source: ndc

Packages (1)

87078-972-32 12 POUCH in 1 CARTON (87078-972-32) / 15 mL in 1 POUCH (87078-972-03)

Ingredients (4)

acetaminophen (650 mg/15mL) dextromethorphan hydrobromide (20 mg/15mL) guaifenesin (400 mg/15mL) phenylephrine hydrochloride (10 mg/15mL)

Linked Drug Pages (1)

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

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "45fa9159-d74d-063a-e063-6294a90a3ed0", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "spl_set_id": ["45fa9159-d74c-063a-e063-6294a90a3ed0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["MEDWISE LIFESCIENCES INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (87078-972-32)  / 15 mL in 1 POUCH (87078-972-03)", "package_ndc": "87078-972-32", "marketing_start_date": "20251215"}], "brand_name": "ONESSIP ADULT DAYTIME SEVERE COLD AND FLU", "product_id": "87078-972_45fa9159-d74d-063a-e063-6294a90a3ed0", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "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": "87078-972", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI", "labeler_name": "MEDWISE LIFESCIENCES INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ONESSIP ADULT DAYTIME SEVERE COLD AND FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251215", "listing_expiration_date": "20261231"}