Acetaminophen

Product NDC
37808-333
11-digit product format
378080333
Labeler code
37808
Product ID
37808-333_a67ea2d8-b415-4468-9e7a-bae4172428a0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H-E-B
Application
ANDA076200
Marketing category
ANDA
Marketing start
2002-04-30
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 productproduct37808-333IInactivated by FDA2026-08-03
excluded packagepackage37808-33337808-333-01IInactivated by FDA2026-08-03
excluded packagepackage37808-33337808-333-50IInactivated by FDA2026-08-03

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 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 packagepackage37808-333-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-333-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-333-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-333-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-333-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-333-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-333-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-333-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-333-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-333-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-333-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-333-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-333-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-333-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-333-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-333-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-333-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-333-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-333-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-333-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-333-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-333-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-333-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-333-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37808-333-508af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage37808-333-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37808-333-50834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage37808-333-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37808-333-501332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage37808-333-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37808-333-50fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage37808-333-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37808-333-5086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage37808-333-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37808-333-50bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage37808-333-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37808-333-508dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage37808-333-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37808-333-50e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage37808-333-01e2bbac7714bc…27bdfed8d636…

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
A076200-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19

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 UTC2026-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076200-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2002-03-19cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-333-012020-01-31C16284748780-19d75b9d0-3a96-f424-e053-dadaa90a57ceDrug Facts
37808-333-502020-01-31C16284748780-19d75b9d0-3a96-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-333-01Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
37808-333-50Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE11
37808-333-50Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-333ACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1Legacy NDC, 3 package rows20141125_a67ea2d8-b415-4468-9e7a-bae4172428a0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENMedline Industries, LP9f18d455-55ce-482c-8da8-dcb664038c6c2026-04-10WarningsExact identifier
application applno (ANDA): 076200
application number: ANDA076200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNa67ea2d8-b415-4468-9e7a-bae4172428a01
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDa67ea2d8-b415-4468-9e7a-bae4172428a01
11483998 HR APAP 650 MG Extended Release Oral TabletSYa67ea2d8-b415-4468-9e7a-bae4172428a01
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYa67ea2d8-b415-4468-9e7a-bae4172428a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37808-333-0137808033301100 in 1 BOTTLEHistorical
37808-333-50378080333501 in 1 CARTONHistorical