cystex pm

Generic: acetaminophen, diphenhydramine hcl

Labeler: clarion brands, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name cystex pm
Generic Name acetaminophen, diphenhydramine hcl
Labeler clarion brands, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
Clarion Brands, LLC

Identifiers & Regulatory

Product NDC 69693-417
Product ID 69693-417_46f3c199-aa9e-b9c9-e063-6394a90a9f7e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2022-01-28

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 69693417
Hyphenated Format 69693-417

Supplemental Identifiers

RxCUI
1092189
UNII
362O9ITL9D TC2D6JAD40

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 cystex pm (source: ndc)
Generic Name acetaminophen, diphenhydramine hcl (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69693-417-10) / 10 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (69693-417-20) / 20 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

69693-417-10 1 BLISTER PACK in 1 CARTON (69693-417-10) / 10 TABLET in 1 BLISTER PACK 69693-417-20 1 BLISTER PACK in 1 CARTON (69693-417-20) / 20 TABLET in 1 BLISTER PACK

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Cystex PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46f3c199-aa9e-b9c9-e063-6394a90a9f7e", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["9668a2ca-729e-4172-80b5-33e6c5175ba4"], "manufacturer_name": ["Clarion Brands, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69693-417-10)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "69693-417-10", "marketing_start_date": "20220601"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69693-417-20)  / 20 TABLET in 1 BLISTER PACK", "package_ndc": "69693-417-20", "marketing_start_date": "20220128"}], "brand_name": "Cystex PM", "product_id": "69693-417_46f3c199-aa9e-b9c9-e063-6394a90a9f7e", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "69693-417", "generic_name": "Acetaminophen, Diphenhydramine HCl", "labeler_name": "Clarion Brands, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cystex", "brand_name_suffix": "PM", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220128", "listing_expiration_date": "20261231"}