Naproxen PM
- Product NDC
- 63868-411
- 11-digit product format
- 638680411
- Labeler code
- 63868
- Product ID
- 63868-411_1c022098-f18b-4542-9f01-1ab82ddb83d6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- QUALITY CHOICE (Chain Drug Marketing Association)
- Application
- ANDA209726
- Marketing category
- ANDA
- Marketing start
- 2019-01-31
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 220 mg/1; mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63868-411 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 63868-411 | 63868-411-20 | D | Discontinued by firm | 2026-09-14 |
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 | 63868-411-20 | 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 | 63868-411-20 | f5e01cc5f278… | a2eaf40c39c3… |
Orange Book products#
| 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 Orange Book product history#
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… |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-05-04 | Drug Facts |
| 2023-01-30 | Drug Facts |
| 2020-11-30 | Drug Facts |
| 2020-09-27 | Drug Facts |
| 2020-09-25 | Drug Facts |
| 2020-07-22 | Drug Facts |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Naproxen Sodium PM | NAPROXEN SODIUM | Strategic Sourcing Services LLC | 7aadfdd4-f8f5-4b7a-a388-1889c3d7d8ba | 2025-08-20 | Warnings | 209726 ANDA209726 |
| Naproxen Sodium PM | NAPROXEN SODIUM | Strategic Sourcing Services LLC | 03a331d8-c957-4949-894f-51d9bd15e0d0 | 2025-08-20 | Warnings | 209726 ANDA209726 |
| Naproxen Sodium and Diphenhydramine HCl | NAPROXEN SODIUM AND DIPHENHYDRAMINE | Amneal Pharmaceuticals NY LLC | caca14cf-95f2-4c60-8bba-2154b8f353a3 | 2023-12-30 | Warnings | 209726 ANDA209726 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63868-411-20 | 63868041120 | 1 BOTTLE, PLASTIC in 1 BOX (63868-411-20) > 20 TABLET in 1 BOTTLE, PLASTIC | 2019-01-31 | 0000-00-00 | No | No | Current |