Health Mart Arthritis Pain

Product NDC
62011-0450
11-digit product format
620110450
Labeler code
62011
Product ID
62011-0450_6d3846fb-ee80-4320-952f-0eba3e53437e
Type
HUMAN OTC DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA211253
Marketing category
ANDA
Marketing start
2020-06-03
Marketing end
0000-00-00
Substance
DICLOFENAC SODIUM
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0450DDiscontinued by firm2026-10-05
excluded packagepackage62011-045062011-0450-1DDiscontinued by firm2026-10-05

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0450-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0450-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0450-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0450-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0450-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0450-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0450-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0450-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0450-10efc9e666f02…f202fb6c5f17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211253-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1684e616aacf4f…
2026-08-18 06:07:402026-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICALAB2019-05-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A211253-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A211253-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A211253-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A211253-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MOTRIN ARTHRITIS PAINDICLOFENAC SODIUMKenvue Brands LLCdb5b4288-13ec-826b-e053-2995a90a275e2024-11-08WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Company8e53e5fa-fda2-4e3a-8c5a-82435e3d51c32024-11-01WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUMA-S Medication Solutions5f1ca9c1-c7fe-4a91-af5e-dc22b175f0832024-09-26WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
diclofenac sodiumDICLOFENAC SODIUMNuCare Pharmaceuticals, Inc.20ef08a3-35cf-b4d6-e063-6394a90a012e2024-08-30WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.005299ac-b6de-511f-e063-6294a90a29e02024-07-29WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMPadagis Israel Pharmaceuticals Ltd17bd62a8-b697-48cc-b988-aac3c19c6dc52024-01-22WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMCVS Pharmacye9ccaf95-582b-4d4d-938f-7577eaa8dffb2023-11-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
equaline arthritis pain relievingDICLOFENAC SODIUMUnited Natural Foods, Inc. dba UNFI748b6134-0c1d-4e9c-a93a-fcc6e4d0b6d02023-08-23WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
equate arthritis painDICLOFENAC SODIUMWal-Mart Stores Inc5e80f6b6-b3f4-4b76-82da-1fc98cb9ad1b2023-07-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
berkley and jensen arthritis painDICLOFENAC SODIUMBJWC441cf367-b293-47e8-a8fb-32e3314be7de2023-07-26WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
CareOne arthritis pain reliefDICLOFENAC SODIUMAmerican Sales Company69615972-b593-44fb-ae49-9441d872d84a2023-06-08WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
DG health arthritis painDICLOFENAC SODIUMDolgencorp Ince7f93d8f-df2b-4005-b58d-c6f10ae0e0f32023-05-24WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relieverDICLOFENAC SODIUMPublix Super Markets Inc445de976-9a28-4e97-929f-c77aeb21c1fa2023-05-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relievingDICLOFENAC SODIUMMeijer Distribution Incd46a4841-2f86-4e0e-ac79-9b1444ed4f792023-05-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
topcare athritis pain relieverDICLOFENAC SODIUMTopco Associates LLCd3e9416d-e13b-4cc7-a663-6df3534b8dbe2023-05-10WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUML. Perrigo Company7b32b9e4-6502-4fa3-808f-3bef9525b6a12023-05-10WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relieverDICLOFENAC SODIUMH E Be8fe4a89-586d-461c-b242-b68e38a508b42023-03-09WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Diclofenac SodiumDICLOFENAC SODIUMRite Aid Corporation1c9ea3b2-8f45-420b-87d3-dc7de0be2d5f2022-08-23WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
good sense arthritis painDICLOFENAC SODIUMProficient Rx LP67eacd91-8378-47e7-9bad-1e7b685aa9d42022-06-01WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
basic care arthritis painDICLOFENAC SODIUMAmazon.com Services LLCa8aa9016-bf2d-4727-9184-512b2570000b2022-01-06WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62011-0450-1620110450011 TUBE in 1 CARTON (62011-0450-1) > 100 g in 1 TUBE1 tube2020-06-030000-00-00NoNoCurrent