Acetaminophen

Product NDC
58602-730
11-digit product format
586020730
Labeler code
58602
Product ID
58602-730_462dae43-f3b8-4f6c-846b-de19a01d169c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207229
Marketing category
ANDA
Marketing start
2016-11-09
Substance
ACETAMINOPHEN
Active strength
650 mg/1
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
A207229-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09

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 UTC2026-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09cb3db0bc1861…

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
179c221d-c099-400c-b3ac-124e26947620Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-730-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE249
58602-730-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-14Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE509
58602-730-14Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-21Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-21Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1009
58602-730-28Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-28Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2259
58602-730-29Acetaminophen150 in 1 BOTTLETABLET, EXTENDED RELEASE1509
58602-730-34Acetaminophen200 in 1 BOTTLETABLET, EXTENDED RELEASE2009
58602-730-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2259
58602-730-36Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE19
58602-730-36Acetaminophen250 in 1 BOTTLETABLET, EXTENDED RELEASE2509
58602-730-40Acetaminophen500 in 1 BOTTLETABLET, EXTENDED RELEASE5009
58602-730-41Acetaminophen1000 in 1 BOTTLETABLET, EXTENDED RELEASE10009
58602-730-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4009
58602-730-67Acetaminophen290 in 1 BOTTLETABLET, EXTENDED RELEASE2909
58602-730-76Acetaminophen325 in 1 BOTTLETABLET, EXTENDED RELEASE3259
58602-730-94Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-730-94EA - Each58602-7307ab748be-d1a1-4866-ae62-6ce6c0b6d4b912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-730ACETAMINOPHEN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]9Current NDC, Legacy NDC, 19 package rows20240126_179c221d-c099-400c-b3ac-124e26947620.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLCe072e4ab-669d-40ee-b301-0bc15b67792f2026-05-21WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENBetter Living Brands, LLCde3d9840-4ada-5c9a-e053-2a95a90a57212026-04-21WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENAmerican Health Packaging88e5345a-f240-473c-b329-2b0aa5f081f92026-02-04WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENKROGER COMPANYb9b63c38-83e7-62d2-e053-2a95a90a55262024-10-19WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENBluePoint Laboratoriesc065c531-88f5-0930-e053-2a95a90ae8612024-06-05WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113df1bc-a217-33ea-e063-6294a90a46432024-05-14WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENWALGREEN CO.c20d110a-ed5e-aed4-e053-2a95a90a42002024-05-06WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENAurohealth LLCf076fd33-9eaf-49b9-b0ee-6a349567c5ff2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.b70beee4-407e-547c-e053-2a95a90af22a2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENAurohealth LLC179c221d-c099-400c-b3ac-124e269476202024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
ndc (product): 58602-730
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.e577fdf0-85b1-1471-e053-2995a90a6fcd2024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229
AcetaminophenACETAMINOPHENWALMART INC.0035a4fd-8dd5-4534-a1b5-f510d637f7212024-01-24WarningsExact identifier
application applno (ANDA): 207229
application number: ANDA207229

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN179c221d-c099-400c-b3ac-124e269476209
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD179c221d-c099-400c-b3ac-124e269476209
11483998 HR APAP 650 MG Extended Release Oral TabletSY179c221d-c099-400c-b3ac-124e269476209
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY179c221d-c099-400c-b3ac-124e269476209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-730-07586020730071 BOTTLE in 1 CARTON (58602-730-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-14586020730141 BOTTLE in 1 CARTON (58602-730-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-21586020730211 BOTTLE in 1 CARTON (58602-730-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2018-08-110000-00-00NoNoCurrent
58602-730-28586020730281 BOTTLE in 1 CARTON (58602-730-28) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2021-12-290000-00-00NoNoCurrent
58602-730-2958602073029150 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-29) 2018-08-110000-00-00NoNoCurrent
58602-730-3458602073034200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-34) 2018-08-110000-00-00NoNoCurrent
58602-730-3558602073035225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-35) 2018-08-110000-00-00NoNoCurrent
58602-730-36586020730361 BOTTLE in 1 CARTON (58602-730-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE1 bottle2016-11-090000-00-00NoNoCurrent
58602-730-4058602073040500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-40) 2018-08-110000-00-00NoNoCurrent
58602-730-41586020730411000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-41) 2018-08-110000-00-00NoNoCurrent
58602-730-4458602073044400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-44) 2021-01-110000-00-00NoNoCurrent
58602-730-6758602073067290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-67) 2018-08-110000-00-00NoNoCurrent
58602-730-7658602073076325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) 2018-08-110000-00-00NoNoCurrent
58602-730-9458602073094100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-94) 2020-04-080000-00-00NoNoCurrent