Home NDC 85509-1406 Diclofenac Sodium
Product NDC 85509-1406
11-digit product format 855091406
Labeler code 85509
Product ID 85509-1406_41da3d90-4847-0d8f-e063-6294a90aede1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION
Route TOPICAL
Labeler PHOENIX RX LLC
Application ANDA207714
Marketing category ANDA
Marketing start 2022-05-09
Substance DICLOFENAC SODIUM
Active strength 20 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A207714-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207714-001 AB
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 table 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 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207714-001 DICLOFENAC SODIUM 2% SOLUTION / TOPICAL AB 2022-05-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 20 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1487074 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85509-1406-1 Diclofenac Sodium 1 in 1 CARTON SOLUTION 1 1 85509-1406-1 Diclofenac Sodium 112 g in 1 BOTTLE SOLUTION 112 1
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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac Sodium DICLOFENAC SODIUM PHOENIX RX LLC 4382cc15-8978-4f3b-e063-6394a90a9ecb 2025-11-14 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207714 application number: ANDA207714 Diclofenac Sodium DICLOFENAC SODIUM PHOENIX RX LLC 41da2e11-58c7-9622-e063-6394a90a9fdb 2025-10-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207714 application number: ANDA207714 ndc (product): 85509-1406 Diclofenac Sodium DICLOFENAC SODIUM Apotex Corp. 9f416595-60b2-c921-5df4-a09d5f6abe71 2025-09-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207714 application number: ANDA207714 Diclofenac Sodium DICLOFENAC SODIUM Advanced Rx of Tennessee, LLC 3d71f76d-bb23-7251-e063-6394a90aa9d8 2025-08-27 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207714 application number: ANDA207714 Diclofenac Sodium DICLOFENAC SODIUM Preferred Pharmaceuticals Inc. 31b56330-6870-48b7-a8c4-0639e0766b25 2025-03-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207714 application number: ANDA207714
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85509-1406-1 85509140601 1 BOTTLE in 1 CARTON (85509-1406-1) / 112 g in 1 BOTTLE 1 bottle 2025-10-23 No No Current