members mark arthritis pain

Product NDC
68196-544
11-digit product format
681960544
Labeler code
68196
Product ID
68196-544_18ba5bb0-9698-4792-badc-3239855dbea5
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sam's West Inc
Application
ANDA075077
Marketing category
ANDA
Marketing start
2005-08-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct68196-544DDiscontinued by firm2026-08-03
excluded packagepackage68196-54468196-544-82DDiscontinued by firm2026-08-03

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct68196-544DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68196-54468196-544-82DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A075077-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25

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 UTC2026-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f01610625f2…
2019-09-15 20:21 UTC2019-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68196-544-82EA - Each68196-5445ad17487-67a0-42ed-86ef-374b591eecf312024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-544MEMBERS MARK ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAM'S WEST INC]6Legacy NDC20200317_1c225a56-0725-4b22-b9df-13a60212d6e2.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 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen 650mgACETAMINOPHENForreal Pharmaceuticals, LLC12a4c301-c052-454e-a8b2-ad626153f5f72026-06-24WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
dg health 8 hr arthritis pain reliefACETAMINOPHENDolgencorp Incfc7838a7-fc6d-41b7-b8e4-97bee2bfa6d42026-06-17WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEFACETAMINOPHENAmerisource Bergenae07a064-fdbd-4bb4-8252-9c122bf3dd812026-06-02WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Good Sense Pain ReliefACETAMINOPHENL. Perrigo Companycb5f6008-6884-402a-8a19-c8d585576d632026-06-01WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
EQUATE MENSTRUAL PAIN RELIEFACETAMINOPHENWALMART INC.e387ae77-27e9-455a-b708-43288411b2c12026-04-29WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
good sense pain relief arthritis painACETAMINOPHENL. Perrigo Company236eedd4-6ece-46ce-9ab3-12366d57126b2026-02-09WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
equate 8hr arthritis pain reliefACETAMINOPHENWALMART INC.36a0cac6-f5d1-4679-8bef-d52577fc0d572026-02-09WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Members Mark Arthritis PainACETAMINOPHENSam's West Inc4cbe2880-fea9-4d7b-9e7f-a0c794864a842025-12-23WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Midol Long Lasting ReliefACETAMINOPHENBayer HealthCare LLC.4a3a711d-c882-3525-e054-00144ff8d46c2025-12-04WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Leader 8HR Arthritis Pain ReliefACETAMINOPHENCardinal Health 110, LLC. dba Leader2b28e5aa-da4b-4fee-ad49-e5fd6f1c65f62025-11-10WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Care One arthritis pain reliefACETAMINOPHENAmerican Sales Companyc5865a69-4fe4-4f0d-9e03-5927dd7374452025-10-06WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
8 hr arthritis painACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED68e5b8a7-17ca-4a29-9f0c-7350fcf659282025-09-30WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
CareOne 8 Hour Pain ReliefACETAMINOPHENAmerican Sales Company9b2b0ef0-7071-4536-8f74-8f1d6250e1052025-09-04WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
good sense pain relief arthritis painACETAMINOPHENBryant Ranch Prepack7b0b07f6-242a-4e1a-ab39-84f0334d47162025-08-26WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
good sense pain relief arthritis painACETAMINOPHENASCLEMED USA INC.2315ec07-e5b8-4332-8bc2-4e28e88892f32025-06-27WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
topcare 8 hr arthritis pain reliefACETAMINOPHENTopco Associates LLCa82f8818-1c22-46d0-b05f-698d2395ac482025-06-13WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Topcare 8 Hour Pain ReliefACETAMINOPHENTopco Associates LLC38abe710-3d8a-41b0-b057-38c5dfd533222025-05-13WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
basic care acetaminophenACETAMINOPHENAmazon.com Services LLCe88731b1-a6a9-407a-b7f8-b58d88aa92642025-05-10WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
arthritis pain reliefACETAMINOPHENPublix Super Markets Incaf407852-5476-421d-a80a-d726c24b63912025-05-09WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
arthritis pain relieverACETAMINOPHENWalgreen Company5028c116-d0e3-4e30-8fa8-caaf08d99ec72025-05-09WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-544-8268196054482200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68196-544-82) 2005-08-310000-00-00NoNoCurrent