Indications and uses
for relief of occasional sleeplessness when associated with minor aches and pains help you fall asleep and stay asleep
for relief of occasional sleeplessness when associated with minor aches and pains help you fall asleep and stay asleep
do not take more than directed drink a full glass of water with each dose adults and children 12 years and over: take 2 tablets at bedtime do not take more than 2 tablets in 24 hours if taken with food, this product may take longer to work
Diphenhydramine hydrochloride 25 mg
Naproxen sodium 220 mg (naproxen 200 mg) (NSAID)*
*nonsteroidal anti-inflammatory drug
Nighttime sleep-aid
Pain reliever
Allergy alert: Naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed
ask a health professional before use. It is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
carnauba wax, FD&C blue #2, aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, titanium dioxide
Call 1-888-309-9030
Compare to the active ingredients of Aleve® PM**
Naproxen Sodium PM
Naproxen Sodium 220 mg/
Pain reliever (NSAID)
Diphenhydramine HCI 25 mg/
Nighttime sleep-aid
Caplets
(†Capsule-Shaped Tablets)
**This product is not manufactured or distributed by Bayer Health Care, LLC, distributor of Aleve® PM
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INGORMATION.
DISTRIBUTED BY DOLGENCORP, LLC
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55910-854-20 | 2020-12-04 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-40 | 2020-12-04 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-20 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-40 | 2020-09-27 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-20 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-40 | 2020-09-25 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-20 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
| 55910-854-40 | 2020-07-22 | C162847 | 48780-1 | ab0e2407-2672-f274-e053-dbdaa90a6471 | Drug Facts |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 55910-854 | 55910-854-20, 55910-854-40 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NAPROXEN SODIUM | 9TN87S3A3C | ACTIB |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| FD&C BLUE NO. 2 | L06K8R7DQK | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| POVIDONE | FZ989GH94E | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| TALC | 7SEV7J4R1U | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM | 25MG;220MG | TABLET / ORAL | 2018-10-23 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A209726-001 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE | 25MG;220MG | TABLET / ORAL | 2018-10-23 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| a662cc95-9cef-4ee0-a4bd-c75b20392d78 | a16d1925-c01e-4a00-ba01-e9d699b65e7d | 2022-12-02 | Warnings | a662cc95-9cef-4ee0-a4bd-c75b20392d78 a16d1925-c01e-4a00-ba01-e9d699b65e7d |
Adverse event summaries are temporarily unavailable. Other product information remains available.