FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cystex
Brand name suffix
PM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-417-10Cystex PM10 in 1 BLISTER PACKTABLET105
69693-417-10Cystex PM1 in 1 CARTONTABLET15
69693-417-20Cystex PM20 in 1 BLISTER PACKTABLET205
69693-417-20Cystex PM1 in 1 CARTONTABLET15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN9668a2ca-729e-4172-80b5-33e6c5175ba45
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD9668a2ca-729e-4172-80b5-33e6c5175ba45
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY9668a2ca-729e-4172-80b5-33e6c5175ba45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69693-417-10696930417101 BLISTER PACK in 1 CARTON (69693-417-10) / 10 TABLET in 1 BLISTER PACK1 blister pack2022-06-010000-00-00NoNoCurrent
69693-417-20696930417201 BLISTER PACK in 1 CARTON (69693-417-20) / 20 TABLET in 1 BLISTER PACK1 blister pack2022-01-280000-00-00NoNoCurrent