Regular Strength Pain Relief

Product NDC
68071-4656
Requested package NDC
68071-4656-5
11-digit product format
680714656
Labeler code
68071
Product ID
68071-4656_1ab856e2-c792-0d29-e063-6294a90a025b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1989-01-01
Substance
ACETAMINOPHEN
Active strength
325 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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-465668071-4656-5IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-465668071-4656-5IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-465668071-4656-5IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
Regular Strength Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 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
313782Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7c73fc75-af9b-177c-e053-2a91aa0ada56Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-13gc 102
2023-01-30gc 102
2021-02-17gc 102
2021-01-29gc 102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4656-5Regular Strength Pain Relief50 in 1 BOTTLETABLET504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4656REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240615_7c73fc75-af9b-177c-e053-2a91aa0ada56.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 56 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINAcme United Corporationf7f9dc46-a945-7ae3-e053-6394a90a11922024-11-08WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLCde5c6654-56c5-40d3-a286-f04ed47ac7c82024-11-07WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEAcme United Corporationf7bf126d-a6f1-231a-e053-6294a90a04e12024-11-07WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company49021ae8-9655-4885-9f74-52df4cdcb26f2024-11-07WarningsExact identifier
application number: M013
aspirinASPIRINA-S Medication Solutions65c41c20-2f9c-4012-900b-c2ffdf6651442024-11-06WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC338021bd-b92b-45eb-a4b8-bc4a100ab7182024-11-06WarningsExact identifier
application number: M013
basic care headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCf85d2f4c-8184-4555-a310-3979722e860b2024-11-05WarningsExact identifier
application number: M013
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
application number: M013
dg health headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Incddf40cc4-d73f-4460-be72-9486134329a72024-11-05WarningsExact identifier
application number: M013
DOLO- NeuroBion Acetaminophen 500mgACETAMINOPHENBENARD INDUSTRIES INC16f8415d-8190-4212-b487-c0caf7d3bee22024-11-04WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC8c3343ee-d7b6-496d-9702-6736539a72702024-11-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN7c73fc75-af9b-177c-e053-2a91aa0ada564
313782acetaminophen 325 MG Oral TabletSCD7c73fc75-af9b-177c-e053-2a91aa0ada564
313782APAP 325 MG Oral TabletSY7c73fc75-af9b-177c-e053-2a91aa0ada564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4656-56807146560550 TABLET in 1 BOTTLE (68071-4656-5) 50 tablet2018-12-070000-00-00NoNoCurrent