Home Applications 211253 Application 211253
Type ANDA
Sponsor PERRIGO UK FINCO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL;TOPICAL 1% No No
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 A211253-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16
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 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL AB 2019-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 f41ea6bd6efb…
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 2 of 2 · 40 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 64 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-1189 good sense arthritis pain diclofenac sodium L. Perrigo Company ANDA Current 0113-1189 good sense arthritis pain diclofenac sodium L. Perrigo Company ANDA Current 0280-0039 Aleve Arthritis Pain Gel Diclofenac Sodium Bayer HealthCare LLC ANDA Current 0280-0039 Aleve Arthritis Pain Gel Diclofenac Sodium Bayer HealthCare LLC ANDA Current 0363-1871 diclofenac sodium diclofenac sodium Walgreen Company ANDA Current 0363-1871 diclofenac sodium diclofenac sodium Walgreen Company ANDA Current 0363-1871 diclofenac sodium diclofenac sodium Walgreen Company ANDA Current 11673-569 up and up arthritis pain reliever diclofenac sodium Target Corporation ANDA Current 11673-569 up and up arthritis pain reliever diclofenac sodium Target Corporation ANDA Current 11673-569 up and up arthritis pain reliever diclofenac sodium Target Corporation ANDA Current 11822-0870 Diclofenac Sodium diclofenac sodium Rite Aid Corporation ANDA Current 21130-313 signature care arthritis pain diclofenac sodium Safeway ANDA Current 21130-313 signature care arthritis pain diclofenac sodium Safeway ANDA Current 36800-526 topcare athritis pain reliever diclofenac sodium Topco Associates LLC ANDA Current 36800-526 topcare athritis pain reliever diclofenac sodium Topco Associates LLC ANDA Current 36800-526 topcare athritis pain reliever diclofenac sodium Topco Associates LLC ANDA Current 37808-087 Diclofenac Sodium diclofenac sodium H E B ANDA Current 37808-087 Diclofenac Sodium diclofenac sodium H E B ANDA Current 37808-087 Diclofenac Sodium diclofenac sodium H E B ANDA Current 41163-087 equaline arthritis pain relieving diclofenac sodium Supervalu Inc ANDA Current 41163-087 equaline arthritis pain relieving diclofenac sodium Supervalu Inc ANDA Current 41167-0573 Aspercreme Arthritis Diclofenac Sodium Chattem, Inc. ANDA Current 41250-674 arthritis pain relieving diclofenac sodium Meijer Distribution Inc ANDA Current 41250-674 arthritis pain relieving diclofenac sodium Meijer Distribution Inc ANDA Current 41250-674 arthritis pain relieving diclofenac sodium Meijer Distribution Inc ANDA Current 41520-788 CareOne arthritis pain relief diclofenac sodium American Sales Company ANDA Current 41520-788 CareOne arthritis pain relief diclofenac sodium American Sales Company ANDA Current 45802-160 DICLOFENAC SODIUM diclofenac sodium Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-160 DICLOFENAC SODIUM diclofenac sodium Perrigo New York Inc ANDA Current 45802-160 DICLOFENAC SODIUM diclofenac sodium Perrigo New York Inc ANDA Current 45802-160 DICLOFENAC SODIUM diclofenac sodium Perrigo New York Inc ANDA Current 45802-160 DICLOFENAC SODIUM diclofenac sodium Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-953 Diclofenac Sodium diclofenac sodium Perrigo New York Inc ANDA Current 45802-953 Diclofenac Sodium diclofenac sodium Padagis Israel Pharmaceuticals Ltd ANDA Current 46122-646 good neighbor pharmacy arthritis pain diclofenac sodium Amerisource Bergen ANDA Current 46122-646 good neighbor pharmacy arthritis pain diclofenac sodium Amerisource Bergen ANDA Current 46122-646 good neighbor pharmacy arthritis pain diclofenac sodium Amerisource Bergen ANDA Current 49035-262 equate arthritis pain diclofenac sodium Wal-Mart Stores Inc ANDA Current 49035-262 equate arthritis pain diclofenac sodium Wal-Mart Stores Inc ANDA Current 50580-574 MOTRIN ARTHRITIS PAIN Diclofenac sodium Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-574 MOTRIN ARTHRITIS PAIN Diclofenac sodium Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 50580-574 MOTRIN ARTHRITIS PAIN Diclofenac sodium Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division ANDA Current 55910-424 DG health arthritis pain diclofenac sodium Dolgencorp, LLC ANDA Current 55910-424 DG health arthritis pain diclofenac sodium Dolgencorp, LLC ANDA Current 56062-878 arthritis pain reliever diclofenac sodium Publix Super Markets Inc ANDA Current 56062-878 arthritis pain reliever diclofenac sodium Publix Super Markets Inc ANDA Current 62011-0450 Health Mart Arthritis Pain diclofenac sodium Strategic Sourcing Services LLC ANDA Current 62011-0450 Health Mart Arthritis Pain diclofenac sodium Strategic Sourcing Services LLC ANDA Current 63629-8644 DICLOFENAC SODIUM diclofenac sodium Bryant Ranch Prepack ANDA Current 63629-8644 DICLOFENAC SODIUM diclofenac sodium Bryant Ranch Prepack ANDA Current 63629-8644 DICLOFENAC SODIUM diclofenac sodium Bryant Ranch Prepack ANDA Current 63981-870 kirkland signature diclofenac sodium diclofenac sodium Costco Wholesale Company ANDA Current 63981-870 kirkland signature diclofenac sodium diclofenac sodium Costco Wholesale Company ANDA Current 68391-205 berkley and jensen arthritis pain diclofenac sodium BJWC ANDA Current 68391-205 berkley and jensen arthritis pain diclofenac sodium BJWC ANDA Current 69842-729 Diclofenac Sodium diclofenac sodium CVS Pharmacy ANDA Current 69842-729 Diclofenac Sodium diclofenac sodium CVS Pharmacy ANDA Current 70677-0108 Sunmark Arthritis Pain diclofenac sodium Strategic Sourcing Services LLC ANDA Current 70677-0108 Sunmark Arthritis Pain diclofenac sodium Strategic Sourcing Services LLC ANDA Current 71205-618 DICLOFENAC SODIUM diclofenac sodium Proficient Rx LP ANDA Current 71205-618 DICLOFENAC SODIUM diclofenac sodium Proficient Rx LP ANDA Current 71205-670 good sense arthritis pain diclofenac sodium Proficient Rx LP ANDA Current 72288-870 basic care arthritis pain diclofenac sodium Amazon.com Services LLC ANDA Current 72288-870 basic care arthritis pain diclofenac sodium Amazon.com Services LLC ANDA Current