Fenoprofen Calcium
- Product NDC
- 53217-169
- 11-digit product format
- 532170169
- Labeler code
- 53217
- Product ID
- 53217-169_c44a6c19-77e8-48df-8e42-0b7c5681fa84
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fenoprofen calcium
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- NDA017604
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2016-05-19
- Marketing end
- 0000-00-00
- Substance
- FENOPROFEN CALCIUM
- Active strength
- 400 mg/1
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- 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 | 53217-169 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 53217-169 | 53217-169-90 | I | Inactivated by FDA | 2026-08-10 |
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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 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 | 53217-169-90 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 53217-169-90 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 53217-169-90 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 53217-169-90 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 53217-169-90 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 53217-169-90 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 53217-169-90 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53217-169-90 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 53217-169-90 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 53217-169-90 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 53217-169-90 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53217-169-90 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53217-169-90 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017604-002 | NALFON | FENOPROFEN CALCIUM | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | ||
| N017604-003 | NALFON | FENOPROFEN CALCIUM | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N017604-004 | NALFON | FENOPROFEN CALCIUM | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2009-07-21 |
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 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017604-003 | NALFON | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017604-004 | NALFON | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2009-07-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017604-003 | NALFON | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017604-004 | NALFON | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2009-07-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017604-003 | NALFON | EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017604-004 | NALFON | EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2009-07-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017604-003 | NALFON | EQ 200MG BASE | CAPSULE / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017604-004 | NALFON | EQ 400MG BASE | CAPSULE / ORAL | RLD | 2009-07-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N017604-002 | NALFON | EQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | N017604-003 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N017604-004 | AB | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017604-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017604-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N017604-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N017604-004 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N017604-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N017604-004 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017604-003 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017604-004 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017604-003 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017604-004 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017604-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017604-004 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017604-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017604-004 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N017604-004 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N017604-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017604-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N017604-004 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N017604-004 | AB | 1 | e64feba35796… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0916fe0d-58e1-5e07-2471-9a804a1b0628 | Product name | 3 | 20240514 |
| 090af53b-bc54-1ac8-5eee-2f06b5d9cff9 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-169-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d936-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Fenoprofen Calcium Capsules, USP safely and effectively. See full prescribing information for Fenoprofen Calcium Capsules, USP. Fenoprofen Calcium Capsules, USP for oral use Initial U.S. Approval: 1982 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-169-90 | Fenoprofen Calcium | 90 in 1 BOTTLE | CAPSULE | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53217-169-90 | EA - Each | 53217-169 | 49e813ac-f628-4fc7-b5a8-60c04feb9a5a | 1 | 2017-03-06 |
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 |
|---|---|---|---|---|---|---|
| Fenoprofen Calcium | FENOPROFEN CALCIUM | Misemer Pharmaceuticals, Inc. | d33ad329-1ca6-ac2e-e053-2995a90a15c5 | 2026-04-17 | Boxed warning, Warnings, Adverse reactions | 017604 NDA017604 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 858116 | fenoprofen calcium 400 MG Oral Capsule | PSN | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
| 858116 | fenoprofen 400 MG Oral Capsule | SCD | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
| 858116 | fenoprofen (as fenoprofen calcium) 400 MG Oral Capsule | SY | 7bf7114a-b053-46cc-9e00-dc3cc87b50a9 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-169-90 | 53217016990 | 90 in 1 BOTTLE | Historical |