Home NDC 50268-237-20 Diclofenac sodium
Product NDC 50268-237
Requested package NDC 50268-237-20
11-digit product format 502680237
Labeler code 50268
Product ID 50268-237_bc7b6137-2577-3a38-e053-2a95a90adfce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac
Dosage form GEL
Route TOPICAL
Labeler AvPAK
Application ANDA208077
Marketing category ANDA
Marketing start 2021-03-01
Marketing end 0000-00-00
Substance DICLOFENAC SODIUM
Active strength 10 mg/g
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 2022-12-31
Current FDA listing Historical FDA.report record 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A208077-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2016-03-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208077-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2016-03-18 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 2 · 21 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Diclofenac sodium DICLOFENAC SODIUM CVS Pharmacy 591cc2ed-e667-4779-a426-8a2e6f873573 2026-07-22 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM CARDINAL HEALTH 110, LLC. DBA LEADER 70000 081b43f9-f594-4b1e-8564-7dbbea6fa5bd 2026-05-26 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Walgreens 33a37e3d-0463-428c-9169-240eeb77af2b 2026-04-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Rugby Laboratories 95f3c70c-eded-4d24-b9b0-cfa0b7902d6e 2026-02-10 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM Family Dollar (FAMILY WELLNESS) 03ddf347-a3a3-4313-87d1-a246c1d4e0b4 2026-01-29 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Sportpharm LLC ac631742-119f-408a-8b36-b041bab743e2 2026-01-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM QUALITY CHOICE (Chain Drug Marketing Association) 98f94aa2-6bc2-4c07-81c8-63b2c262cf39 2026-01-06 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Safeway, Inc. 196d8af7-739f-4d2c-8c4e-9d33e6d722ab 2025-12-23 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Best Choice (Valu Merchandisers Company) 4ea809a9-387a-4193-a176-d8b22eaa55e6 2025-08-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM Chain Drug Consortium, LLC 8879a2ed-6c66-4489-8adc-9f160241cc7d 2025-06-25 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC Scholl's Wellness Company 8dcbce69-945b-4913-a279-ee10871f6580 2024-11-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Salonpas DICLOFENAC SODIUM Hisamitsu America, Inc. f439445d-046e-4220-a4a7-13d750ee0949 2024-11-14 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC Amneal Pharmaceuticals NY LLC 1084e0c3-6d75-4090-84dc-02a18e0299b9 2023-12-29 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM Care One (Retail Business Services, LLC.) 4484a332-aab1-46a9-aca8-159e7a09439f 2023-11-17 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM CVS PHARMACY, INC 4808015d-cfee-4f4d-a84b-82099f0b4868 2023-10-04 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM AmerisourceBergen (Good Neighbor Pharmacy) 46122 30e1f589-b322-48b7-9a97-502afe2a1baa 2023-08-09 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 2a7019e9-e20f-4897-9b8e-942a7f2b34f6 2023-02-21 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Costco Wholesale 141b6693-6d6c-45c6-9b82-ee1afcfca12a 2023-01-27 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Arthritis Pain Reliever DICLOFENAC SODIUM P & L Development, LLC 2596645a-b736-4d3c-82a0-00713f1b6fbd 2022-12-15 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077 Diclofenac sodium DICLOFENAC SODIUM Costco Wholesale dbe33463-fa5c-4dc9-9d98-4d553fa43465 2022-10-11 Warnings Exact identifier application applno (ANDA): 208077 application number: ANDA208077
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-237-20 50268023720 20 TUBE in 1 BOX (50268-237-20) > 2 g in 1 TUBE (50268-237-11) 20 tube 2021-03-01 0000-00-00 No No Current