Naproxen Sodium
- Product NDC
- 69230-305
- 11-digit product format
- 692300305
- Labeler code
- 69230
- Product ID
- 69230-305_49a51a12-e729-4c42-b623-293681704854
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Camber Consumer Care
- Application
- ANDA208363
- Marketing category
- ANDA
- Marketing start
- 2018-12-31
- Marketing end
- 0000-00-00
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 | 69230-305 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 69230-305 | 69230-305-20 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 69230-305 | 69230-305-80 | D | Discontinued by firm | 2026-08-03 |
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 | 69230-305-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 69230-305-80 | 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 | 69230-305-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 69230-305-80 | 0efc9e666f02… | f202fb6c5f17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A208363-001 | NAPROXEN SODIUM | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A208363-001 | NAPROXEN SODIUM | EQ 200MG BASE | CAPSULE / ORAL | 2018-03-15 | cb3db0bc1861… |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 69230-305-20 | 2020-10-20 | Drug Facts |
| 69230-305-80 | 2020-10-20 | Drug Facts |
| 69230-305-20 | 2020-09-27 | Drug Facts |
| 69230-305-80 | 2020-09-27 | Drug Facts |
| 69230-305-20 | 2020-09-25 | Drug Facts |
| 69230-305-80 | 2020-09-25 | Drug Facts |
| 69230-305-20 | 2020-07-22 | Drug Facts |
| 69230-305-80 | 2020-07-22 | Drug Facts |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69230-305-20 | EA - Each | 69230-305 | bd96d19c-71ed-43fe-a429-c8301463e71f | 1 | 2019-03-12 |
| 69230-305-80 | EA - Each | 69230-305 | 56d29b61-184f-4a8a-b682-ffdd288d3fb3 | 1 | 2019-03-12 |
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 | NAPROXEN SODIUM | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | c28c4fd2-1428-421c-b62f-265e472d833e | 2026-07-09 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | CVS Pharmacy | c194124b-a5f6-423e-bc9a-7b611df990a8 | 2026-05-13 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Walgreens | d9806ad8-1cea-4599-97ef-a956ec7f0e21 | 2026-03-11 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Safeway, Inc. | deb1be0f-64ae-46b5-b54a-1a58eec6492e | 2026-01-05 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | P & L Development, LLC | fc65fe79-c93b-4247-b9af-e562792a3e64 | 2025-08-19 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | AAFES/Your Military Exchanges | c387f7cb-7cc4-4989-9f9a-bb00a895fd0d | 2025-05-08 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Productos Zapotol Corp. | 6386f6f6-9bc7-4b85-ac87-03fd14725904 | 2024-03-14 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Productos Zapotol Corp. | 0a69f39e-5eb6-4a98-85f0-87e7449672d6 | 2024-03-14 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Care One (Retail Business Services, LLC.) | 5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad | 2024-02-21 | Warnings | 208363 ANDA208363 |
| All Day Relief | NAPROXEN SODIUM | Publix Supermarkets, Inc. | 4db86c5b-62bb-4638-9f1e-98dc2680d6cc | 2024-01-23 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | TARGET Corporation | 36ce5cd9-8c61-4ed9-b840-c29ad98bdfc5 | 2023-10-25 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Strategic Sourcing Services LLC | 435e55b2-3d75-4a1e-9f00-69b29baf37af | 2023-10-02 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Care One (American Sales Company) | 043f7032-4e83-4642-93a8-6c09de26b43f | 2022-11-21 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Strategic Sourcing Services LLC | a636037d-127c-478d-9d61-dda6eafd2e81 | 2022-11-15 | Warnings | 208363 ANDA208363 |
| Naproxen Sodium | NAPROXEN SODIUM | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | de03311d-fb58-43f5-a110-aac9a39c9132 | 2022-11-07 | Warnings | 208363 ANDA208363 |
| NAPROXEN SODIUM | NAPROXEN SODIUM | PuraCap Pharmaceutical LLC | fc865e81-164c-48e9-8fb9-6fc27d1c33cf | 2019-12-10 | Warnings | 208363 ANDA208363 |
| NAPROXEN SODIUM | NAPROXEN SODIUM | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 1d5981dd-e3f5-48a3-a5f1-ce49689cdfac | 2019-11-08 | Warnings | 208363 ANDA208363 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69230-305-20 | 69230030520 | 1 BOTTLE, PLASTIC in 1 BOX (69230-305-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2018-12-31 | 0000-00-00 | No | No | Current |
| 69230-305-80 | 69230030580 | 1 BOTTLE, PLASTIC in 1 BOX (69230-305-80) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2018-12-31 | 0000-00-00 | No | No | Current |