Diclofenac Sodium
- Product NDC
- 70518-2811
- Requested package NDC
- 70518-2811-0
- 11-digit product format
- 705182811
- Labeler code
- 70518
- Product ID
- 70518-2811_4e42d4e0-b229-84ef-e063-6294a90ab3cb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- SOLUTION
- Route
- TOPICAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203818
- Marketing category
- ANDA
- Marketing start
- 2020-07-10
- Substance
- DICLOFENAC SODIUM
- Active strength
- 16.05 mg/mL
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203818-001 | DICLOFENAC SODIUM | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203818-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | 2014-11-26 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203818-001 | DICLOFENAC SODIUM | 1.5% | SOLUTION / TOPICAL | AT | RS | 2014-11-26 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203818-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203818-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203818-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203818-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203818-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203818-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203818-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203818-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203818-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203818-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203818-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203818-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A203818-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A203818-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A203818-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A203818-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A203818-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A203818-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A203818-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A203818-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A203818-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A203818-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A203818-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A203818-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A203818-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A203818-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A203818-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A203818-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A203818-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A203818-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A203818-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A203818-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A203818-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A203818-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A203818-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A203818-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A203818-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A203818-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A203818-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A203818-001 | AT | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 16.05 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| QTG126297Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 857700 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d349d286-b462-4f8f-aa39-6173653175d6 | Available on FDA.report |
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 |
| 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#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70518-2811-0 | Diclofenac Sodium | 1 in 1 CARTON | SOLUTION | 1 | 10 | |
| 70518-2811-0 | Diclofenac Sodium | 150 mL in 1 BOTTLE, DROPPER | SOLUTION | 150 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70518-2811-0 | ML - Milliliter | 70518-2811 | 3a1f9c28-6866-4224-b1d7-fbc3ad43c5e1 | 1 | 2026-02-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70518-2811 | DICLOFENAC SODIUM SOLUTION [REMEDYREPACK INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250403_d349d286-b462-4f8f-aa39-6173653175d6.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 | DICLOFENAC SODIUM | Preferred Pharmaceuticals, Inc. | 4a3549e0-1e2d-42bf-b82c-1e62837ba2e4 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | REMEDYREPACK INC. | d349d286-b462-4f8f-aa39-6173653175d6 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 70518-2811-0 70518-2811 70518281100 |
| DICLOFENAC SODIUM | DICLOFENAC SODIUM | DirectRx | d5f215d4-9aa3-2ecf-e053-2995a90a2e89 | 2026-03-17 | Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Sun Pharmaceutical Industries, Inc. | fae53d24-acf1-4250-888d-b8d965ffc3d3 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Asclemed USA, Inc. | 5508f80d-5f11-4959-8e42-9055f0169cfc | 2025-02-08 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Direct_Rx | f80b0b95-f4da-2d6c-e053-6294a90acf92 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Advanced Rx of Tennessee, LLC | 0803345d-7811-bc21-e063-6394a90aa661 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | A-S Medication Solutions | 0379c918-1717-40ab-81cc-268116950fd5 | 2023-10-03 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac Sodium | DICLOFENAC SODIUM | Proficient Rx LP | 1c1ee94c-60d6-4cfc-bb66-1d4f6e630512 | 2022-05-02 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
| Diclofenac sodium | DICLOFENAC SODIUM | Proficient Rx LP | b0f9e649-6651-406f-a9fe-157fe04d9d27 | 2020-02-01 | Boxed warning, Warnings, Adverse reactions | 203818 ANDA203818 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857700 | diclofenac sodium 1.5 % Topical Solution | PSN | d349d286-b462-4f8f-aa39-6173653175d6 | 10 |
| 857700 | diclofenac sodium 15 MG/ML Topical Solution | SCD | d349d286-b462-4f8f-aa39-6173653175d6 | 10 |
| 857700 | diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical Solution | SY | d349d286-b462-4f8f-aa39-6173653175d6 | 10 |
| 857700 | diclofenac sodium 16.05 MG per 1 ML Topical Solution | SY | d349d286-b462-4f8f-aa39-6173653175d6 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-2811-0 | 70518281100 | 1 BOTTLE, DROPPER in 1 CARTON (70518-2811-0) / 150 mL in 1 BOTTLE, DROPPER | 2020-07-10 | 0000-00-00 | No | No | Current |