Diclofenac Sodium
- Product NDC
- 51021-250
- 11-digit product format
- 510210250
- Labeler code
- 51021
- Product ID
- 51021-250_83eada1e-9f07-953f-e053-2a91aa0aea0e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION/ DROPS
- Route
- TRANSDERMAL
- Labeler
- Sircle Laboratories, LLC
- Application
- ANDA204132
- Marketing category
- ANDA
- Marketing start
- 2015-08-20
- Marketing end
- 0000-00-00
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16 mg/mL
- Pharmacologic classes
- Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 | 51021-250 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 51021-250 | 51021-250-05 | I | Inactivated by FDA | 2026-10-05 |
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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 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 | 51021-250-05 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204132-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204132-001 | AT |
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 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A204132-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2015-08-20 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204132-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A204132-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204132-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204132-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204132-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204132-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204132-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204132-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204132-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204132-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204132-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204132-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204132-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204132-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204132-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A204132-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204132-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A204132-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A204132-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A204132-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A204132-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A204132-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A204132-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A204132-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A204132-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A204132-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A204132-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A204132-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A204132-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204132-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A204132-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A204132-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204132-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204132-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204132-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204132-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A204132-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A204132-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204132-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A204132-001 | AT | 1 | f41ea6bd6efb… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51021-250-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-25a7-111a-e063-dadaa90a10e2 | These highlights do not include all the information needed to use Diclofenac Sodium Topical Solution safely and effectively. See full prescribing information for Diclofenac Sodium Topical Solution. DICLOFENAC Sodium Topical Solution 1.5% w/w is for topical use only. Initial U.S. Approval: 1988 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51021-250-05 | Capsinac | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 mL | 16.05 mg in 1mL | 3 |
| 51021-250-05 | Diclosaicin | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 mL | 16.05 mg in 1mL | 2 |
| 51021-250-05 | Diclofenac Sodium | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 | 2 | |
| 51021-250-05 | Iclofenac CP | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 mL | 16.05 mg in 1mL | 1 |
| 51021-250-05 | Ziclopro | 150 mL in 1 BOTTLE | SOLUTION/ DROPS | 150 mL | 16.05 mg in 1mL | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51021-250-05 | ML - Milliliter | 51021-250 | 8f7230c4-b928-494c-a6d9-cd24964f0d08 | 1 | 2016-07-19 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 51021-250 | CAPSINAC (DICLOFENAC SODIUM AND CAPSAICIN) KIT [BODYSPHERE, LLC] | 3 | Legacy NDC | 20200828_a8b0e656-faef-4ac9-ace1-04241e5e241a.zip |
| 51021-250 | DICLOFENAC SODIUM SOLUTION/ DROPS [SIRCLE LABORATORIES, LLC] | 2 | Legacy NDC, 1 package rows | 20190313_6f14d3bb-353d-4e03-beb7-6117a4a780bb.zip |
| 51021-250 | DICLOSAICIN (DICLOFENAC SODIUM AND CAPSAICIN) KIT [CHADWICK PHARMACEUTICALS, INC] | 2 | Legacy NDC | 20220724_25e2ca69-236c-4282-85cd-3a4e1d9db024.zip |
| 51021-250 | ICLOFENAC CP (DICLOFENAC SODIUM AND CAPSAICIN) KIT [CHADWICK PHARMACEUTICALS, INC] | 1 | Legacy NDC | 20211028_24dd02a2-2937-4d39-abe2-714d18cd2c3a.zip |
| 51021-250 | ZICLOPRO (DICLOFENAC SODIUM AND CAPSAICIN) KIT [ASHOKA HEALTH] | 1 | Legacy NDC | 20210617_8b902129-03b4-4ab7-8ee7-160bd7f4c606.zip |
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 |
|---|---|---|---|---|---|---|
| Diclofenac Sodium 1.5% | DICLOFENAC SODIUM TOPICAL | SOLA Pharmaceuticals | c3f33952-44a8-71b2-e053-2a95a90abda2 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium 1.5% | DICLOFENAC SODIUM TOPICAL | PHOENIX RX LLC | 3b40a448-3f5e-fe6f-e063-6394a90a32df | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | DIRECT RX | a5b33bf7-8113-9c54-e053-2995a90a79d8 | 2025-01-20 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium 1.5% | DICLOFENAC SODIUM TOPICAL | Preferred Pharmaceuticals Inc. | dbcd42cf-d44a-4d47-9149-66ffcf9a0587 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | f18a4691-93a1-01e6-e053-2995a90a0069 | 2024-12-05 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium 1.5% | DICLOFENAC SODIUM TOPICAL | Proficient Rx LP | 90b25b9b-3930-48af-b139-d24f2fccfcdc | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 2021-01-21 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 20107264-e533-4de9-9a37-59fde7981c92 | 2020-09-01 | Boxed warning, Warnings, Adverse reactions | 204132 ANDA204132 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 20107264-e533-4de9-9a37-59fde7981c92 | 4 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 20107264-e533-4de9-9a37-59fde7981c92 | 4 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 20107264-e533-4de9-9a37-59fde7981c92 | 4 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 20107264-e533-4de9-9a37-59fde7981c92 | 4 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | a8b0e656-faef-4ac9-ace1-04241e5e241a | 3 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 3d976518-60d2-478a-e054-00144ff88e88 | 3 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | a8b0e656-faef-4ac9-ace1-04241e5e241a | 3 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 3d976518-60d2-478a-e054-00144ff88e88 | 3 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | a8b0e656-faef-4ac9-ace1-04241e5e241a | 3 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 3d976518-60d2-478a-e054-00144ff88e88 | 3 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | a8b0e656-faef-4ac9-ace1-04241e5e241a | 3 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 3d976518-60d2-478a-e054-00144ff88e88 | 3 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 6f14d3bb-353d-4e03-beb7-6117a4a780bb | 2 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 25e2ca69-236c-4282-85cd-3a4e1d9db024 | 2 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 25e2ca69-236c-4282-85cd-3a4e1d9db024 | 2 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 6f14d3bb-353d-4e03-beb7-6117a4a780bb | 2 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 6f14d3bb-353d-4e03-beb7-6117a4a780bb | 2 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 25e2ca69-236c-4282-85cd-3a4e1d9db024 | 2 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 25e2ca69-236c-4282-85cd-3a4e1d9db024 | 2 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 6f14d3bb-353d-4e03-beb7-6117a4a780bb | 2 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 7dc7fb31-3323-7672-e053-2991aa0abff5 | 1 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 1 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 8b902129-03b4-4ab7-8ee7-160bd7f4c606 | 1 |
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | 24dd02a2-2937-4d39-abe2-714d18cd2c3a | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 7dc7fb31-3323-7672-e053-2991aa0abff5 | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 8b902129-03b4-4ab7-8ee7-160bd7f4c606 | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | 24dd02a2-2937-4d39-abe2-714d18cd2c3a | 1 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 7dc7fb31-3323-7672-e053-2991aa0abff5 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 8b902129-03b4-4ab7-8ee7-160bd7f4c606 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 1 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | 24dd02a2-2937-4d39-abe2-714d18cd2c3a | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | f3f60cd3-8f1f-4ca4-9621-805b4a6c35a8 | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 24dd02a2-2937-4d39-abe2-714d18cd2c3a | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 8b902129-03b4-4ab7-8ee7-160bd7f4c606 | 1 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | 7dc7fb31-3323-7672-e053-2991aa0abff5 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51021-250-05 | 51021025005 | 150 mL in 1 BOTTLE (51021-250-05) | 150 ml | 2016-05-30 | 0000-00-00 | No | No | Current |