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.
| 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 |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9668a2ca-729e-4172-80b5-33e6c5175ba4 | Available on FDA.report |
DailyMed Product Concepts#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Lil Drug Store Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | de59aae2-f794-4243-acc8-37a10e27abde | 2023-12-15 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN TABLET, EXTRA STRENGTH | Lil' Drug Store Products, Inc. | f0fdab5a-9d07-57aa-e053-2a95a90adc7f | 2023-12-15 | Warnings | M013 |
| BC Cherry | ASPIRIN AND CAFFEINE | Lil' Drug Store Products, Inc | 79ea721b-d656-44f7-9d13-390debee7be0 | 2023-12-15 | Warnings | M013 |
| Alka-Seltzer | BUFFERED ASPIRIN | Lil' Drug Store Products, Inc. | 0c7a60e7-0bde-9aa2-e063-6294a90a3209 | 2023-12-14 | Warnings | M013 |
| Circle K Aspirin 325 | ASPIRIN | Lil Drug Store Products, Inc | 4cd306e3-2119-4272-9da4-a848fe2746fa | 2023-12-14 | Warnings | M013 |
| Circle K Pain Reliever Extra Strength | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | f2359bc3-901f-4ecb-b402-cb2fe404a935 | 2023-12-14 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | c55b8f9d-1396-43c0-acc9-5e3485eadb07 | 2023-12-08 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 775519ad-5683-451f-9bfc-5fafc70c68ec | 2023-12-08 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | WALGREEN CO. | c20c814b-35f5-4c46-e053-2a95a90a50f2 | 2023-12-08 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Better Living Brands LLC | f9859be4-6d0b-2ab8-e053-6294a90aa862 | 2023-12-06 | Warnings | M013 |
| Aurophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | b9b7b849-c3b3-9af7-e053-2a95a90a0077 | 2023-12-06 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | KROGER COMPANY | cf649478-57d2-cc88-e053-2a95a90ad1ba | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | KROGER COMPANY | b9b6f878-1ec8-3dc0-e053-2995a90a5414 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | a48c522c-76c5-49f8-8c4d-3ee6b221e6f3 | 2023-12-06 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | WALGREEN CO. | cc939a7c-ce56-5dd6-e053-2995a90aa8af | 2023-12-06 | Warnings | M013 |
| Alka-Seltzer Original Flavor | BUFFERED ASPIRIN, EFFERVESCENT TABLET | Lil' Drug Store Products, Inc. | ea5df8be-a08c-5fa3-e053-2995a90a0bac | 2023-12-06 | Warnings | M013 |
| Ringl | ACETAMINOPHEN | Sato Pharmaceutical Co., Ltd. | ba5a0286-3e0f-4bef-96e5-29d92f51f432 | 2023-12-06 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 41633554-474e-4d3c-9187-d90487d2ae8c | 2023-12-06 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Family Dollar Stores, LLC | f86dcbb8-debc-4bce-e053-6294a90a7a02 | 2023-12-05 | Warnings | M013 |
| Sanatos Multi Symptom Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Pharmadel LLC | 0a5fc0ef-ba34-bb0b-e063-6394a90af7d9 | 2023-12-01 | Warnings | M013 |
DailyMed RxNorm Mappings#
| 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 | 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 |