good sense pain relief

Product NDC
71335-2545
11-digit product format
713352545
Labeler code
71335
Product ID
71335-2545_db613953-71d0-4fcf-a801-d0b67a5ca287
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075077
Marketing category
ANDA
Marketing start
2005-11-21
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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25c2088c7a36db…
2026-09-14 22:38:342026-08A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-2584e616aacf4f…
2026-08-18 06:07:402026-07A075077-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2000-02-25caaa826d4ba7…
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…

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
good sense pain relief
Brand name suffix
arthritis pain
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
7b0b07f6-242a-4e1a-ab39-84f0334d4716Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2545-1good sense pain reliefarthritis pain30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE302
71335-2545-2good sense pain reliefarthritis pain100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002
71335-2545-3good sense pain reliefarthritis pain50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE502
71335-2545-4good sense pain reliefarthritis pain60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE602
71335-2545-5good sense pain reliefarthritis pain120 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1202
71335-2545-6good sense pain reliefarthritis pain19 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE192
71335-2545-7good sense pain reliefarthritis pain20 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2545-5EA - Each71335-25452a6c5cde-9891-4f11-8556-fe2f9035f07b12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2545GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]1Current NDC, 7 package rows20250119_7b0b07f6-242a-4e1a-ab39-84f0334d4716.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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Pain Relief 8 HRACETAMINOPHENH E Bb5c7e93b-e626-49c3-a7d4-773475f945ae2022-11-12WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
arthritis pain reliefACETAMINOPHENMeijer Distribution Incc388f3a5-03bb-4fed-b81a-bb876bc260f02022-10-27WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Pain ReliefACETAMINOPHENMeijer Distribution Incbfe37210-b322-4edb-8ff2-aff9b3e66be02022-10-27WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
Equate 8HR Arthritis Pain ReliefACETAMINOPHENWal-Mart Stores Incca7f0f68-2862-4265-bf4a-3a89994b4d6b2022-10-13WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
topcare 8 hr arthritis pain reliefACETAMINOPHENTopco Associates LLC0d427360-ff9d-4e98-b218-6eb6c015dc6a2022-05-23WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077
basic care acetaminophenACETAMINOPHENAmazon.com Services LLCb0c55ac4-0b1a-4411-9df3-6bb64e20ea222022-03-23WarningsExact identifier
application applno (ANDA): 075077
application number: ANDA075077

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN7b0b07f6-242a-4e1a-ab39-84f0334d47162
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD7b0b07f6-242a-4e1a-ab39-84f0334d47162
11483998 HR APAP 650 MG Extended Release Oral TabletSY7b0b07f6-242a-4e1a-ab39-84f0334d47162
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY7b0b07f6-242a-4e1a-ab39-84f0334d47162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2545-17133525450130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-1) 2025-01-17NoNoCurrent
71335-2545-271335254502100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-2) 2025-01-17NoNoCurrent
71335-2545-37133525450350 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-3) 2025-01-17NoNoCurrent
71335-2545-47133525450460 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-4) 2025-01-17NoNoCurrent
71335-2545-571335254505120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-5) 2025-01-17NoNoCurrent
71335-2545-67133525450619 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-6) 2025-01-17NoNoCurrent
71335-2545-77133525450720 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2545-7) 2025-01-17NoNoCurrent