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.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69693-417-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69693-417-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69693-417-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69693-417-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69693-417-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69693-417-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69693-417-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69693-417-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69693-417-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69693-417-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69693-417-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69693-417-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69693-417-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69693-417-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69693-417-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69693-417-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69693-417-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69693-417-10	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9668a2ca-729e-4172-80b5-33e6c5175ba4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 33 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EXTRA STRENGTH PAIN RELIEVER	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Geri-Care Pharmaceutical Corp	b670a898-2360-76e2-e053-2a95a90a3380	2025-11-17	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	ec902e52-0f48-4a61-b67d-17e1c1461619	2025-11-15	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	L.N.K. International, Inc.	72babe91-2586-4f05-ae90-6debfd23aa5d	2025-11-15	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Strategic Sourcing Services LLC	3c7883da-6f51-4716-b012-0e33d239a60e	2025-11-15	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Sam's West Inc	3b84746f-05ab-4f88-b9ae-efb8c5dfc233	2025-11-15	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Walgreen Company	a482e715-bec0-44a4-bb0e-ea5f5fda558e	2025-11-15	Warnings	Exact identifier application number: M013
Acetaminophen PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f1157dbc-d86c-4554-954c-60a74674ff6b	2025-11-15	Warnings	Exact identifier application number: M013
Acetaminophen, Aspirin, Caffeine	ACETAMINOPHEN, ASPIRIN, CAFFEINE	NuCare Pharmaceuticals,Inc.	437e4fd9-c7d9-77d6-e063-6294a90a22b7	2025-11-13	Warnings	Exact identifier application number: M013
Good Sense Pain Relief	ACETAMINOPHEN	L. Perrigo Company	7f78028a-484b-48b3-a37a-1e0b055bbefc	2025-11-13	Warnings	Exact identifier application number: M013
OneSsip Acetaminophen	ACETAMINOPHEN	MEDWISE LIFESCIENCES INC.	3f88de0f-6cf6-3580-e063-6294a90abcb4	2025-11-12	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	435b1a31-353d-af20-e063-6294a90aa907	2025-11-11	Warnings	Exact identifier application number: M013
Good Neighbor Pharmacy Pain Relief	ACETAMINOPHEN	Amerisource Bergen	4b829607-f5fb-427f-83b5-5b6b9c44ebeb	2025-11-11	Warnings	Exact identifier application number: M013
Pamprin Max Menstrual Pain Relief	ACETAMINOPHEN AND ASPIRIN AND CAFFEINE	Focus Consumer Healthcare, LLC	5bd4b935-f003-7df8-e053-2a91aa0a5d79	2025-11-10	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	Shield Pharmaceuticals Corp	61e50135-a7c2-4a86-8a1a-d47b41d3f9d1	2025-11-07	Warnings	Exact identifier application number: M013
Childrens Chewables	ACETAMINOPHEN	Strategic Sourcing Services LLC	af2cbbaf-9b73-440a-bc88-a790cafccc6b	2025-11-07	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	L.N.K. International, Inc.	39e142a7-8590-4e1e-8319-6904fb57cc8a	2025-11-06	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	42321456-d7dd-3b51-e063-6394a90ac292	2025-11-05	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	Family Dollar Services Inc	76058eb3-2d3f-4414-87df-7167cd27d26b	2025-11-05	Warnings	Exact identifier application number: M013
Children Pain and Fever Reliver	ACETAMINOPHEN	Target Corporation	1116f808-f61e-47ec-b0d0-d4be5aa905be	2025-11-04	Warnings	Exact identifier application number: M013
Pain Reliever Dye Free	ACETAMINOPHEN	TIME CAP LABORATORIES, INC.	42c4f0b2-6483-0f3c-e063-6294a90a140f	2025-11-04	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	9668a2ca-729e-4172-80b5-33e6c5175ba4	5
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	9668a2ca-729e-4172-80b5-33e6c5175ba4	5
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	9668a2ca-729e-4172-80b5-33e6c5175ba4	5

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