defensol d blister pack

Generic: acetaminophen, diphenhydramine hcl, phenylephrine hci

Labeler: menper distributors, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name defensol d blister pack
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hci
Labeler menper distributors, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, diphenhydramine hydrochloride 12.5 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Menper Distributors, Inc.

Identifiers & Regulatory

Product NDC 53145-009
Product ID 53145-009_3a893b13-e7eb-c5b1-e063-6394a90a4253
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-01-01

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 53145009
Hyphenated Format 53145-009

Supplemental Identifiers

RxCUI
1233575
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 defensol d blister pack (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl, phenylephrine hci (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 12.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 BOX (53145-009-30) / 30 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

53145-009-30 1 BLISTER PACK in 1 BOX (53145-009-30) / 30 TABLET in 1 BLISTER PACK

Ingredients (3)

acetaminophen (325 mg/1) diphenhydramine hydrochloride (12.5 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Defensol D Blister Pack ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a893b13-e7eb-c5b1-e063-6394a90a4253", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40", "04JA59TNSJ"], "rxcui": ["1233575"], "spl_set_id": ["0dfcc977-6101-4536-e063-6294a90a7a48"], "manufacturer_name": ["Menper Distributors, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 BOX (53145-009-30)  / 30 TABLET in 1 BLISTER PACK", "package_ndc": "53145-009-30", "marketing_start_date": "20240101"}], "brand_name": "Defensol D Blister Pack", "product_id": "53145-009_3a893b13-e7eb-c5b1-e063-6394a90a4253", "dosage_form": "TABLET", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53145-009", "generic_name": "Acetaminophen, Diphenhydramine HCl, Phenylephrine HCI", "labeler_name": "Menper Distributors, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Defensol D Blister Pack", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "12.5 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240101", "listing_expiration_date": "20261231"}