flu relief therapy nighttime

Generic: acetaminophen, diphenhydramine hcl, phenylephrine hcl

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name flu relief therapy nighttime
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl
Labeler top care (topco associates llc)
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, diphenhydramine hydrochloride 25 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-317
Product ID 36800-317_50a1e4d6-f99d-4f7f-877e-f26803460704
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] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] alpha-1 adrenergic agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800317
Hyphenated Format 36800-317

Supplemental Identifiers

RxCUI
1298348
UPC
0036800224483
UNII
362O9ITL9D TC2D6JAD40 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 flu relief therapy nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 25 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 245 mL in 1 BOTTLE, PLASTIC (36800-317-08)
source: ndc

Packages (1)

36800-317-08 245 mL in 1 BOTTLE, PLASTIC (36800-317-08)

Ingredients (3)

acetaminophen (650 mg/30mL) diphenhydramine hydrochloride (25 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Flu Relief Therapy Nighttime ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "50a1e4d6-f99d-4f7f-877e-f26803460704", "openfda": {"upc": ["0036800224483"], "unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1298348"], "spl_set_id": ["ed063755-6bdc-479a-92ab-04120350434d"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "245 mL in 1 BOTTLE, PLASTIC (36800-317-08)", "package_ndc": "36800-317-08", "marketing_start_date": "20150831"}], "brand_name": "Flu Relief Therapy Nighttime", "product_id": "36800-317_50a1e4d6-f99d-4f7f-877e-f26803460704", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "36800-317", "generic_name": "Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Flu Relief Therapy", "brand_name_suffix": "Nighttime", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 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"}