theraflu severe cold relief nighttime

Generic: acetaminophen, diphenhydramine hydrochloride

Labeler: jc world bell wholesale co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name theraflu severe cold relief nighttime
Generic Name acetaminophen, diphenhydramine hydrochloride
Labeler jc world bell wholesale co., inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
JC World Bell Wholesale Co., Inc.

Identifiers & Regulatory

Product NDC 50269-101
Product ID 50269-101_1907b4ac-fdc0-b407-e063-6294a90a344d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-12-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50269101
Hyphenated Format 50269-101

Supplemental Identifiers

RxCUI
2670677
UNII
362O9ITL9D TC2D6JAD40

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 theraflu severe cold relief nighttime (source: ndc)
Generic Name acetaminophen, diphenhydramine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 20 PACKET in 1 BOX (50269-101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET
source: ndc

Packages (1)

50269-101-06 20 PACKET in 1 BOX (50269-101-06) / 1 POWDER, FOR SOLUTION in 1 PACKET

Ingredients (2)

acetaminophen (650 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

THERAFLU SEVERE COLD RELIEF NIGHTTIME ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1907b4ac-fdc0-b407-e063-6294a90a344d", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["2670677"], "spl_set_id": ["6ee1cc52-2d7e-4b53-a0e6-563e623bcb51"], "manufacturer_name": ["JC World Bell Wholesale Co., Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 PACKET in 1 BOX (50269-101-06)  / 1 POWDER, FOR SOLUTION in 1 PACKET", "package_ndc": "50269-101-06", "marketing_start_date": "20231201"}], "brand_name": "THERAFLU SEVERE COLD RELIEF NIGHTTIME", "product_id": "50269-101_1907b4ac-fdc0-b407-e063-6294a90a344d", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50269-101", "generic_name": "ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE", "labeler_name": "JC World Bell Wholesale Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "THERAFLU SEVERE COLD RELIEF NIGHTTIME", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231201", "listing_expiration_date": "20261231"}