Regular Strength Pain Relief

Product NDC
68071-4656
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4656-58af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4656-5834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4656-51332a3947898…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 13 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa, Inc.091dd1e7-2484-cdbf-e063-6394a90a21892026-05-11WarningsExact identifier
application number: M013
Little Remedies Infant Fever/Pain RelieverACETAMINOPHENMedtech Products Inc.af5c3b3b-079f-4ee6-a9a4-a13ee8cd99a52026-05-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWal-Mart Stores Inc093e0458-9975-456f-8950-8273c8890b3c2026-05-11WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYafacdc0b-fb65-464e-91b8-e82ba7ecde442026-05-11WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER CHERRYACETAMINOPHENDeMoulas Market Basket192f7c24-a4aa-4c05-8d64-5e7e0bf7a1012026-05-09WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEVER and FEVER REDUCER GRAPEACETAMINOPHENDeMoulas Market Basket0ff5c86e-d84b-42ad-b749-636ab2e3734e2026-05-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRugby Laboratories939fce7e-55df-4dc5-916b-a533448e962f2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.f7e6e984-f0c3-ed40-e053-6294a90a89f72026-05-08WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.c59cbf0e-1381-4dd2-e053-2a95a90a853a2026-05-08WarningsExact identifier
application number: M013
Genexa Acetaminophen Extra StrengthACETAMINOPHENGenexa Inc.d6f968ca-719f-5a68-e053-2995a90a4afa2026-05-08WarningsExact identifier
application number: M013
Kids Pain and FeverACETAMINOPHENGenexa Inc.a7bd0b92-6f85-6175-e053-2995a90ab8372026-05-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack816b65d7-e53f-44c4-a418-074279d4b2af2026-05-08WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmerisource Bergen566dbd02-5e04-4461-8f5f-9fb58a42a3752026-05-07WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEDOLGENCORP, LLCd4c0c81b-9176-47d0-a5e4-a584406078d92026-05-07WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPinnacle RX LLC513cf0e1-6874-9402-e063-6294a90aedc62026-05-07WarningsExact identifier
application number: M013
Infants Pain and Fever Cherry FlavorACETAMINOPHENGenexa Inc.19215ea7-d55f-8d81-e063-6294a90a49242026-05-07WarningsExact identifier
application number: M013
up and up acetaminophen infantsACETAMINOPHENTarget Corporationc1dd8330-fb6b-4d1f-9484-c199dc69214d2026-05-07WarningsExact identifier
application number: M013
Extra Strength AspirinASPIRINHHH Pharmaceuticals90d457bb-79a7-4759-8ee7-6abffbe1e5492026-05-06WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINHHH Pharmaceuticalsd81aec73-c7c1-4c52-80f6-fb0e32caf7aa2026-05-06WarningsExact 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