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 40 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medique at Home APAP Extra Strength	ACETAMINOPHEN 500 MG	Unifirst First Aid Corporation	b56b4110-fb8f-e5a0-e053-2995a90a0ad3	2025-09-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	64c642b7-ef83-44b7-a014-6fa248dff3ba	2025-09-08	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE	BJWC (Berkley & Jensen / BJ's)	2f473f1f-7cf3-2af5-e063-6394a90aaa17	2025-09-01	Warnings	Exact identifier application number: M013
foster and thrive rapid release pain relief	ACETAMINOPHEN	Strategic Sourcing Services LLC	d2130173-b107-4ae6-a1f7-6db467da3820	2025-08-30	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Precision Dose, Inc.	e1d4f562-433c-4344-9b77-1a7c731d1be5	2025-08-29	Warnings	Exact identifier application number: M013
Aspirin Enteric Coated Low Dose	ASPIRIN	Walgreen Company	b11a4c4e-374c-403e-a757-5e9700f9f03b	2025-08-27	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Safeway	0e0a73f9-8c18-41fd-812e-8be20287e77a	2025-08-26	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	577035a5-88ab-431c-8598-7a19dd633fe9	2025-08-26	Warnings	Exact identifier application number: M013
Topcare Pain Relief	ACETAMINOPHEN	Sixarp, LLC	2e20be17-2b6c-1a07-e063-6394a90acdd3	2025-08-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	BJWC (Berkley & Jensen / BJ's)	2f32b096-d29a-c7c7-e063-6294a90a2bbe	2025-08-22	Warnings	Exact identifier application number: M013
Medique Medi Seltzer	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Unifirst First Aid Corporation	528da9d9-2a52-4c16-b7b2-61b3eee1abea	2025-08-19	Warnings	Exact identifier application number: M013
pain relief	ACETAMINOPHEN	Publix Super Markets Inc	6b691dc1-09e4-46d3-b199-8917e42848a6	2025-08-19	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	P & L Development, LLC	59eb14a5-40b0-4331-beb5-7166e6cdf411	2025-08-18	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	caf5daea-409e-5dd2-e053-2995a90acb12	2025-08-18	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief 100	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c42e48d-cdb2-eb74-e063-6394a90a2940	2025-08-13	Warnings	Exact identifier application number: M013
Dr Simi Pain Relief	ACETAMINOPHEN	Farmacias De Similares TX LLC	3c477d33-a8c2-d39f-e063-6294a90ac5f0	2025-08-13	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	CHAIN DRUG MARKETING ASSOCIATION INC	4005f8dd-3050-4590-8703-6997444e8df3	2025-08-13	Warnings	Exact identifier application number: M013
good sense headache relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L. Perrigo Company	4cae0580-7ee3-4f38-8d13-79c7d7615f8f	2025-08-12	Warnings	Exact identifier application number: M013
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	3bb7dc60-97b2-1291-e063-6294a90a26d9	2025-08-12	Warnings	Exact identifier application number: M013
Dr Simi Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Farmacias De Similares TX LLC	3c19ad99-6e0f-3116-e063-6394a90a914c	2025-08-11	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