Acetaminophen

Product NDC
51660-340
11-digit product format
516600340
Labeler code
51660
Product ID
51660-340_94c05dc3-be35-4ff8-b57e-71fba081b91a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Ohm Laboratories Inc.
Application
ANDA078569
Marketing category
ANDA
Marketing start
2012-12-21
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51660-340DDiscontinued by firm2026-09-09
excluded packagepackage51660-34051660-340-08DDiscontinued by firm2026-09-09
excluded packagepackage51660-34051660-340-20DDiscontinued by firm2026-09-09

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 2 · 63 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 packagepackage51660-340-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51660-340-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-340-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51660-340-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-340-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51660-340-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-340-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51660-340-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-340-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51660-340-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-340-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51660-340-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-340-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51660-340-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-340-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51660-340-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-340-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51660-340-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-340-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51660-340-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-340-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51660-340-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-340-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51660-340-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51660-340-208af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage51660-340-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51660-340-20834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage51660-340-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51660-340-201332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage51660-340-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51660-340-08fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51660-340-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51660-340-0886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51660-340-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51660-340-08bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51660-340-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51660-340-088dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51660-340-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51660-340-08e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51660-340-20e2bbac7714bc…27bdfed8d636…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078569-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143f01610625f2…
2019-09-15 20:21 UTC2019-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078569-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2011-12-14e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51660-340-082020-01-31C16284748780-19d75b9d0-2fb0-f424-e053-dadaa90a57ceDrug Facts
51660-340-202020-01-31C16284748780-19d75b9d0-2fb0-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-340ACETAMINOPHEN TABLET, EXTENDED RELEASE [OHM LABORATORIES INC.]1Legacy NDC20130423_bb95cfad-47ae-4be7-919e-3ae4664460c4.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENCVS Pharmacy6f880abe-5284-42b0-9db6-b071444b197b2024-12-27WarningsExact identifier
application applno (ANDA): 078569
application number: ANDA078569
AcetaminophenACETAMINOPHENWalgreen Companya1cec332-5802-4684-8b7f-6cb98da40e8b2018-08-15WarningsExact identifier
application applno (ANDA): 078569
application number: ANDA078569