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 4 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief childrens	ACETAMINOPHEN	Rite Aid Corporation	29ecdd2d-aeaf-40a8-a347-011088009ea6	2026-08-11	Warnings	Exact identifier application number: M013
Fast Acting Pedia Crae	ACETAMINOPHEN	Randob Labs., Ltd.	e069060f-fbb2-4c7a-b872-00b3ab86d01b	2026-08-11	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	Amazon.com Services LLC	c7cc0681-4c0b-4565-99df-d0168c8ba1ba	2026-08-10	Warnings	Exact identifier application number: M013
GenCare Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Pioneer Life Sciences, LLC	ac8c4bdf-30c9-2b09-e053-2a95a90a9b67	2026-08-09	Warnings	Exact identifier application number: M013
Gencare-Aspirin Low Dose Pain reliever (NSAID)	ASPIRIN	Pioneer Life Sciences, LLC	24d4f46a-c7a5-4e94-804f-1e307d8e8cfc	2026-08-09	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	DOLGENCORP, LLC	b4064039-2345-4227-b83d-54dc13a838d3	2026-08-07	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	87def9e0-0246-42cf-b8ea-2513d52e9f68	2026-08-07	Warnings	Exact identifier application number: M013
berkley and jensen acetaminophen	ACETAMINOPHEN	BJWC	dee57d73-73ac-48bb-b1da-9971f1ff21c4	2026-08-07	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Salado Sales, Inc.	aef30709-f33d-48ff-b2d4-0639ffbd1ffd	2026-08-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	P & L Development, LLC	4cd74cec-a209-4e92-b853-fbe5c95f7678	2026-08-06	Warnings	Exact identifier application number: M013
Tension Headache Aspirin-Free	ACETAMINOPHEN, CAFFEINE	Rite Aid Corporation	093a7c26-f2b1-4416-b193-81133d247d2e	2026-08-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bc17b2e5-4828-6a2e-e053-2995a90a8c63	2026-08-05	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	997b9551-c222-4a9c-8ba1-09a5f97495fa	2026-08-05	Warnings	Exact identifier application number: M013
Mantra Pain Gel raspberry	ACETAMINOPHEN	MOREMED INC.	7c8bdf49-a6d2-4e42-b006-375f103fd0ac	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	d2d2846d-4e0b-4d42-b300-60dd3b2cca1b	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	960f5676-d8c5-470b-a663-4b8d152339b4	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	a60f6439-2033-4bd2-b78c-6c083414a12b	2026-08-05	Warnings	Exact identifier application number: M013
pain relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	HARRIS TEETER	0afb6181-d0b1-4845-8230-faabf1b997dc	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	8a3e3439-90ae-4fc9-8ff2-44b8363fa338	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Harris Teeter	50e7b939-e0eb-44ea-82ea-034e844e2c29	2026-08-05	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