Acetaminophen

Product NDC
11822-5019
11-digit product format
118225019
Labeler code
11822
Product ID
11822-5019_2bd9f035-2806-299c-e063-6394a90ac041
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
RITE AID
Application
ANDA211544
Marketing category
ANDA
Marketing start
2024-11-01
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11822-5019-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11822-5019-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11822-5019-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11822-5019-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11822-5019-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11822-5019-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11822-5019-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11822-5019-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11822-5019-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11822-5019-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11822-5019-41332a3947898…d4bfe170f9cd…

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
A211544-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16

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 22:38:342026-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1684e616aacf4f…
2026-08-18 06:07:402026-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211544-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2019-04-16f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1148399Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1f18c32-c043-7c97-e053-2a95a90a203eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-5019-2Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1005
11822-5019-3Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE505
11822-5019-4Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5019ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [RITE AID]5Current NDC, Legacy NDC, 2 package rows20250119_d1f18c32-c043-7c97-e053-2a95a90a203e.zip
11822-5019ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [RITE AID]2Current NDC, Legacy NDC, 1 package rows20250322_d20b4682-fed2-3ea2-e053-2995a90aa47e.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 2 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENWalgreens0944a5d4-2ccc-5f0d-e063-6394a90a8af92025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRITE AIDd20b4682-fed2-3ea2-e053-2995a90aa47e2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 11822-5019
AcetaminophenACETAMINOPHENFAMILY DOLLARf824602a-8e7b-b8c3-e053-6294a90a6d9d2025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRITE AIDd20a7f7a-febf-54f9-e053-2a95a90a06b12025-12-19WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8 Hour Arthritis PainACETAMINOPHENVALU MERCHANDISERS COMPANYcd3a7094-ddb5-4583-a1bc-dc6ce280418c2025-12-11WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8 Hour Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd11a7412-a543-0e34-e053-2995a90afd632025-12-11WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC2e30754a-42f7-4da2-944c-be61cee47b432025-12-10WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Arthritis PainACETAMINOPHENAMERIFOODS TRADING COMPANY3802bc07-3154-f36a-e063-6294a90ac1cc2025-11-20WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Pain ReliefACETAMINOPHENHYVEE INC42394377-c874-a955-e063-6294a90ace0b2025-11-20WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Arthritis PainACETAMINOPHENHYVEE INC3e61b583-c1cb-23bd-e063-6294a90aa0062025-11-20WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Arthritis PainACETAMINOPHENAAA Pharmaceutical, Inc.3e9b237c-5df4-9ec5-e063-6394a90a87de2025-09-12WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
Arthritis PainACETAMINOPHENDISCOUNT DRUG MART973bcf75-8c45-ea16-e053-2a95a90aad632025-06-30WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8HR Arthritis PainACETAMINOPHENFSA STORE INC.06446e9a-0e83-0623-e063-6294a90ac4032025-03-07WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
AcetaminophenACETAMINOPHENRITE AIDd1f18c32-c043-7c97-e053-2a95a90a203e2025-01-16WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ndc (product): 11822-5019
TYLENOL 8 HR MUSCLE ACHES AND PAINACETAMINOPHENKenvue Brands LLC037ec598-cba6-dbb6-e063-6394a90ac42c2024-11-07WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
arthritis pain reliefACETAMINOPHENMeijer9f03fdb0-7dc0-376e-e053-2995a90ace052024-10-11WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8 Hour Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC1da0bd23-9f26-4913-9ebf-1fd8b0fb3bd32024-10-11WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepackf6dc5576-9ba3-436c-87f5-8d0d6258adef2024-10-07WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
TYLENOL 8 HR ARTHRITIS PAINACETAMINOPHENKenvue Brands LLC0391963c-022d-1433-e063-6294a90aac902024-09-09WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544
8 Hour Pain ReliefACETAMINOPHENAMERISOURCE BERGEN9ab903aa-7170-460b-9527-e3df223f5f552024-07-24WarningsExact identifier
application applno (ANDA): 211544
application number: ANDA211544

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd1f18c32-c043-7c97-e053-2a95a90a203e5
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd1f18c32-c043-7c97-e053-2a95a90a203e5
11483998 HR APAP 650 MG Extended Release Oral TabletSYd1f18c32-c043-7c97-e053-2a95a90a203e5
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd1f18c32-c043-7c97-e053-2a95a90a203e5
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd20b4682-fed2-3ea2-e053-2995a90aa47e3
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd20b4682-fed2-3ea2-e053-2995a90aa47e3
11483998 HR APAP 650 MG Extended Release Oral TabletSYd20b4682-fed2-3ea2-e053-2995a90aa47e3
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd20b4682-fed2-3ea2-e053-2995a90aa47e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-5019-211822501902100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-2) 2024-11-010000-00-00NoNoCurrent
11822-5019-31182250190350 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-3) 2024-11-010000-00-00NoNoCurrent
11822-5019-411822501904100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-4) 2021-11-300000-00-00NoNoCurrent