Home NDC 11673-028 Diclofenac Sodium
Product NDC 11673-028
11-digit product format 116730028
Labeler code 11673
Product ID 11673-028_44f66b1f-6634-4fe1-a988-5cbe70fe3b91
Type HUMAN OTC DRUG
Nonproprietary name Diclofenac Sodium
Dosage form GEL
Route TOPICAL
Labeler Target Corporation
Application ANDA204306
Marketing category ANDA
Marketing start 2026-09-01
Substance DICLOFENAC SODIUM
Active strength 10 mg/g
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204306-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table 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 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-06 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-06 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-06 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-06 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204306-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-06 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 10 mg/g
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.
Matched openFDA labels page 1 of 1 · 12 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11673-028-10 11673002810 1 TUBE in 1 CARTON (11673-028-10) / 100 g in 1 TUBE 1 tube 2026-09-01 No No Current 11673-028-15 11673002815 1 TUBE in 1 CARTON (11673-028-15) / 150 g in 1 TUBE 1 tube 2026-09-01 No No Current