Home NDC 68391-205 berkley and jensen arthritis pain
Product NDC 68391-205
11-digit product format 683910205
Labeler code 68391
Product ID 68391-205_f8497dc3-9d28-4ad9-8770-eb36ed0563cb
Type HUMAN OTC DRUG
Nonproprietary name diclofenac sodium
Dosage form KIT
Labeler BJWC
Application ANDA211253
Marketing category ANDA
Marketing start 2021-11-10
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 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# Additional Listing Data#
Finished product Yes
Brand name base berkley and jensen arthritis pain
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855633 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 68391-205-00 berkley and jensen arthritis pain 1 in 1 PACKAGE KIT 1 3 68391-871-00 berkley and jensen arthritis pain 2 in 1 CARTON GEL 10 mg in 1g 3 68391-871-02 berkley and jensen arthritis pain 1 in 1 CARTON GEL 10 mg in 1g 3 68391-871-02 berkley and jensen arthritis pain 50 g in 1 TUBE GEL 50 g 10 mg in 1g 3 68391-871-03 berkley and jensen arthritis pain 150 g in 1 TUBE GEL 300 g 10 mg in 1g 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-205 BERKLEY AND JENSEN ARTHRITIS PAIN (DICLOFENAC SODIUM) KIT [BJWC] 3 Current NDC, Legacy NDC, 5 package rows 20231130_441cf367-b293-47e8-a8fb-32e3314be7de.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68391-205-00 68391020500 1 KIT in 1 PACKAGE (68391-205-00) * 1 TUBE in 1 CARTON (68391-871-02) / 50 g in 1 TUBE * 2 TUBE in 1 CARTON (68391-871-00) / 150 g in 1 TUBE (68391-871-03) 1 kit 2021-11-10 0000-00-00 No No Current 68391-871-00 68391087100 2 in 1 CARTON Historical 68391-871-02 68391087102 1 in 1 CARTON Historical 68391-871-03 68391087103 150 g in 1 TUBE 150 g Historical