Home NDC 71205-618-00 DICLOFENAC SODIUM
Product NDC 71205-618
Requested package NDC 71205-618-00
11-digit product format 712050618
Labeler code 71205
Product ID 71205-618_0abc944e-a435-4f77-922d-380e5aab6c5f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diclofenac sodium
Dosage form GEL
Route TOPICAL
Labeler Proficient Rx LP
Application ANDA211253
Marketing category ANDA
Marketing start 2019-05-20
Marketing end 0000-00-00
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 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71205-618 71205-618-00 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71205-618 71205-618-00 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 A211253-001 DICLOFENAC SODIUM 1% GEL / TOPICAL 2019-05-16 e64feba35796…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-618 DICLOFENAC SODIUM GEL [PROFICIENT RX LP] 2 Legacy NDC 20220525_94880e4f-6b55-493c-b8b7-9d74df1c4896.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.
Matched openFDA labels page 1 of 2 · 40 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71205-618-00 71205061800 1 TUBE in 1 CARTON (71205-618-00) > 100 g in 1 TUBE 1 tube 2021-11-04 0000-00-00 No No Current