MEMBERS MARK ARTHRITIS PAIN RELIEVER

Product NDC
68196-523
11-digit product format
681960523
Labeler code
68196
Product ID
68196-523_eef65e60-8d74-4fad-817f-b1a8544bb1d3
Type
HUMAN OTC DRUG
Nonproprietary name
DICLOFENAC SODIUM
Dosage form
GEL
Route
TOPICAL
Labeler
Sam's West Inc
Application
ANDA211253
Marketing category
ANDA
Marketing start
2025-07-03
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
2026-12-31
Current FDA listing
Yes

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-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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211253-001DICLOFENAC SODIUM1%GEL / TOPICAL2019-05-16cb3db0bc1861…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
MEMBERS MARK ARTHRITIS PAIN RELIEVER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855633Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d339aaa2-ae7e-4a79-b687-cf0a3106fad0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-523-03MEMBERS MARK ARTHRITIS PAIN RELIEVER150 g in 1 TUBEGEL1502
68196-523-05MEMBERS MARK ARTHRITIS PAIN RELIEVER3 in 1 CARTONGEL32

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARTHRITIS PAIN RELIEFDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED84978746-4ab5-456d-af63-5c86ab0a05f52026-06-29WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relieverDICLOFENAC SODIUMHyVee Incbc74d53d-4142-4391-935b-61b7e353bd652026-04-30WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
TOPCARE ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTopco Associates LLC1d6c4c38-3739-4d58-9811-bac09fcbfadb2026-04-24WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
EQUATE ARTHRITIS PAINDICLOFENAC SODIUMWALMART INC.d05b5f82-8772-4e01-8eb3-6fa6042f56612026-04-20WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
arthritis pain relievingDICLOFENAC SODIUMWalgreen Company0da5d1d0-d8a4-4509-a098-e9c36d2824742026-03-31WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMPublix Super Markets Incbae07276-c800-468e-a201-e6268846fff32026-01-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
DICLOFENAC SODIUM TOPICALDICLOFENAC SODIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED181e32ab-5ec0-4be4-bad0-b6bbafc08f852026-01-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
UP AND UP ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMTarget Corporation3a9b32af-a3cd-496b-9698-0421443e03852025-12-08WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Aleve Arthritis Pain GelDICLOFENAC SODIUMBayer HealthCare LLCbad675d1-1204-0136-e053-2995a90a994e2025-12-04WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMH E B027803c5-85ae-4b86-8bd4-e61f8f34d0362025-11-17WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMMeijer, Inc.5cc570c6-2585-4d1a-9352-b1161458af9a2025-11-17WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
GOOD SENSE ARTHRITIS PAINDICLOFENAC SODIUML. Perrigo Company6e45a111-f6be-4c64-a2d2-7ac51a2ea6a12025-11-07WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
ARTHRITIS PAIN RELIEVINGDICLOFENAC SODIUMWalgreen Companyb1850a16-54f1-4210-abdf-26414da8b3d92025-09-29WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
FOSTER AND THRIVE ARTHRITIS PAINDICLOFENAC SODIUMStrategic Sourcing Services LLCf9f4e55f-ffad-4df7-9b3c-1e7c3a3723c12025-09-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
DG HEALTH ARTHRITIS PAINDICLOFENAC SODIUMDolgencorp Inc6479e4bb-0790-483e-bfe3-a54d549aa5d22025-09-15WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
MEMBERS MARK ARTHRITIS PAIN RELIEVERDICLOFENAC SODIUMSam's West Incd339aaa2-ae7e-4a79-b687-cf0a3106fad02025-07-16WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
ndc (product): 68196-523
kirkland signature arthritis pain reliefDICLOFENAC SODIUMCostco Wholesale Companyc30353da-acd6-474f-8a64-abd078bf4f852025-06-11WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
members mark arthritis pain relieverDICLOFENAC SODIUMSam's West Inc44533b5b-73ce-4853-9eda-506426cb9b822025-06-09WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
up and up arthritis pain relieverDICLOFENAC SODIUMTarget Corporation0b7ae58c-cdaf-4343-a199-7a90bf901eb52025-04-27WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253
Aspercreme ArthritisDICLOFENAC SODIUMChattem, Inc.762b7ef4-166c-43b8-9acd-2b9e7fa0bf362025-01-28WarningsExact identifier
application applno (ANDA): 211253
application number: ANDA211253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSNd339aaa2-ae7e-4a79-b687-cf0a3106fad02
855633diclofenac sodium 0.01 MG/MG Topical GelSCDd339aaa2-ae7e-4a79-b687-cf0a3106fad02
855633diclofenac sodium 1 % Topical GelSYd339aaa2-ae7e-4a79-b687-cf0a3106fad02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68196-523-0368196052303150 g in 1 TUBE150 gHistorical
68196-523-05681960523053 TUBE in 1 CARTON (68196-523-05) / 150 g in 1 TUBE (68196-523-03) 3 tube2025-07-03NoNoCurrent