Home NDC 69693-417 Cystex
Product NDC 69693-417
11-digit product format 696930417
Labeler code 69693
Product ID 69693-417_46f3c199-aa9e-b9c9-e063-6394a90a9f7e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler Clarion Brands, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-28
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 500; 25 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 27 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Cystex
Brand name suffix PM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1092189 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69693-417-10 Cystex PM 10 in 1 BLISTER PACK TABLET 10 5 69693-417-10 Cystex PM 1 in 1 CARTON TABLET 1 5 69693-417-20 Cystex PM 20 in 1 BLISTER PACK TABLET 20 5 69693-417-20 Cystex PM 1 in 1 CARTON TABLET 1 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 31 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Walgreen Company b4d8860b-d72f-4789-945e-1c6420a8efab 2025-12-02 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY f7b304d8-e37c-4ac6-b4a2-1797b92cb832 2025-12-01 Warnings Exact identifier application number: M013 Dye FreeInfants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY 1a304570-88b6-4c16-a8b4-c064bfa5d95a 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Severe Multi-Symptom Cough Cold Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE WALGREENS b48d93fe-bb60-493f-8d1a-b2dc864203c4 2025-12-01 Warnings Exact identifier application number: M013 Multi Symptom Severe Cold and Nighttime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL WALGREEN CO. 6c4ab613-a587-4ec4-9986-f1d000bc2d23 2025-12-01 Warnings Exact identifier application number: M013 WAG HBP Daytime and Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE WALGREENS CO. ac2f9ce8-e402-4451-a412-e99248a6ecbe 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Day Time NightTime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN WALGREENS CO. 5505217a-9679-4668-bdab-5d4553a47c56 2025-12-01 Warnings Exact identifier application number: M013 CAREALL Aspirin ASPIRIN New World Imports, Inc 58a371d4-1f00-4fda-8e08-80610c58505a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Non Aspirin Extra Strength ACETAMINOPHEN New World Imports, Inc da05a1a1-35b4-4787-8c56-12e369f18ff0 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 66244cdb-2680-4fa8-890d-32aefd490038 2025-12-01 Warnings Exact identifier application number: M013 Family Wellness Childrens Pain Reliever 574 ACETAMINOPHEN Family Dollar Services, Inc. 902c1136-04d2-41f0-81c6-412663cdf378 2025-12-01 Warnings Exact identifier application number: M013 WalgreenChildrens Pain Fever ACETAMINOPHEN WALGREENS CO. 2f757cde-2604-4ca4-b54e-e444f3757cdd 2025-11-26 Warnings Exact identifier application number: M013 Walgreen Childrens Pain plus Fever ACETAMINOPHEN WALGREENS CO. 29ca2855-3c07-435d-a8e1-2997fcedd088 2025-11-26 Warnings Exact identifier application number: M013 Walgreens Childrens Cold plus Cough plus Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE WALGREENS CO. 8714d4e6-3a3b-48c8-8ac1-51b933a2ceac 2025-11-26 Warnings Exact identifier application number: M013 Pain Reliever, 24/7 Life by 7-Eleven ACETAMINOPHEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 44828b89-2563-b233-e063-6294a90ab124 2025-11-26 Warnings Exact identifier application number: M013 MEMBERS MARK ACETAMINOPHEN ACETAMINOPHEN Sam's West Inc 03e831d4-8060-4633-9d02-e77100063fb4 2025-11-26 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dissolve Packs ACETAMINOPHEN WALGREENS CO. ea0f265f-7d64-4731-beda-0bb841dd1ad7 2025-11-25 Warnings Exact identifier application number: M013 Sore Throat Logenzes Sore Throat BENZOCAINE AND MENTHOL ATLANTIC BIOLOGICALS CORP. 71a80e13-bda3-40fb-b4e7-45e9985e707c 2025-11-24 Warnings Exact identifier application number: M013 better living brands childrens fever and pain reliver ACETAMINOPHEN BETTER LIVING BRANDS LLC c13ced61-c491-4fc2-b83f-78c6d9ad8546 2025-11-20 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69693-417-10 69693041710 1 BLISTER PACK in 1 CARTON (69693-417-10) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2022-06-01 0000-00-00 No No Current 69693-417-20 69693041720 1 BLISTER PACK in 1 CARTON (69693-417-20) / 20 TABLET in 1 BLISTER PACK 1 blister pack 2022-01-28 0000-00-00 No No Current