FDA.reportPublic FDA data

Xpect Acetaminophen

Product NDC
42961-399
11-digit product format
429610399
Labeler code
42961
Product ID
42961-399_d231c65a-329e-444c-8898-d696efc9583e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Cintas Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42961-39942961-399-04DDiscontinued by firm2026-10-23
excluded packagepackage42961-39942961-399-05DDiscontinued by firm2026-10-23

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 · 2 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42961-39942961-399-05DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42961-39942961-399-04DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
Xpect Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f4aed854-730e-493d-b523-122156e08ddeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-399-01Xpect Acetaminophen2 in 1 PACKETTABLET211
42961-399-04Xpect Acetaminophen100 in 1 BOXTABLET10011
42961-399-05Xpect Acetaminophen250 in 1 BOXTABLET25011
42961-399-06Xpect Acetaminophen25 in 1 BAGTABLET2511
42961-399-07Xpect Acetaminophen50 in 1 BOXTABLET5011
42961-399-08Xpect Acetaminophen125 in 1 BOXTABLET12511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-399XPECT ACETAMINOPHEN (ACETAMINOPHEN) TABLET [CINTAS CORPORATION]6Current NDC, Legacy NDC, 6 package rows20241228_f4aed854-730e-493d-b523-122156e08dde.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 76 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLC30756257-f748-4a5d-b031-dd267d0f91ad2023-11-29WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENAurohealth LLC8eda893f-5266-4b7a-95b9-2e194973cf062023-11-29WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENAurohealth LLC00ec6518-b5e3-49d1-a342-139381c3bfd22023-11-29WarningsExact identifier
application number: M013
CHILDRENS PAIN RELIEFACETAMINOPHENBetter Living Brands, LLCfadb4c09-071f-56c0-e053-6294a90ae6c12023-11-28WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEBetter Living Brands, LLCfc07d516-9ffe-9989-e053-6294a90ae1a52023-11-28WarningsExact identifier
application number: M013
NOTTS - Tension HeadacheACETAMINOPHEN, CAFFEINEVIVUNT PHARMA LLC08f2ae03-967b-ad7e-e063-6294a90a84842023-11-24WarningsExact identifier
application number: M013
Sanatos Multi Symptoms NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0a60326a-a17b-e843-e063-6394a90ac2112023-11-22WarningsExact identifier
application number: M013
Sanatos Nighttime Multi SymptomsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC0ab188f3-f7f9-d665-e063-6294a90a198a2023-11-22WarningsExact identifier
application number: M013
ASPIRINASPIRINTIME CAP LABS INCfe12519c-3e5f-4592-bd34-2d6b81b981f42023-11-22WarningsExact identifier
application number: M013
Rugby Regular Strength AcetaminophenACETAMINOPHENA-S Medication Solutions400d4a29-9e39-4e74-8272-37be5d7899242023-11-22WarningsExact identifier
application number: M013
RIGHT REMEDIES Pain Relief Extra Strength CapletACETAMINOPHENStrive Pharmaceuticals Inc.dcce28d9-8528-489e-b995-1d98e9d0e6ad2023-11-21WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCIPharmadel LLC0ab11691-5b29-55fc-e063-6394a90aa3282023-11-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions1e223faa-f6d0-4235-bc4c-6cfca84a5b0a2023-11-17WarningsExact identifier
application number: M013
SanaTos XACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLC85b8ef3d-7318-7f3b-e053-2991aa0a07772023-11-14WarningsExact identifier
application number: M013
RIGHT REMEDIES EXTRA STRENGTH PM Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8badbaad-eb35-4251-a779-00474819360d2023-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC09935a74-34b0-0e7c-e063-6294a90a7c832023-11-07WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6dd6396-93e9-1096-e053-6394a90af06d2023-11-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.eb644e9e-36dc-5f84-e053-2a95a90affa52023-11-02WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENProficient Rx LP46527b1f-7515-44ce-b5cb-9d24223b9af12023-11-01WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions12feb32b-4b8c-4b17-9e86-cb286457b0882023-11-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNf4aed854-730e-493d-b523-122156e08dde11
198440acetaminophen 500 MG Oral TabletSCDf4aed854-730e-493d-b523-122156e08dde11
198440APAP 500 MG Oral TabletSYf4aed854-730e-493d-b523-122156e08dde11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42961-399-01429610399012 in 1 PACKETHistorical
42961-399-0242961039902250 PACKET in 1 BOX (42961-399-02) > 2 TABLET in 1 PACKET (42961-399-01) 250 packet2021-03-300000-00-00NoNoCurrent
42961-399-0442961039904100 PACKET in 1 BOX (42961-399-04) > 2 TABLET in 1 PACKET (42961-399-01) 100 packet2022-12-290000-00-00NoNoCurrent
42961-399-0542961039905250 PACKET in 1 BOX (42961-399-05) > 2 TABLET in 1 PACKET (42961-399-01) 250 packet2021-03-300000-00-00NoNoCurrent
42961-399-064296103990625 PACKET in 1 BAG (42961-399-06) / 2 TABLET in 1 PACKET (42961-399-01) 25 packet2025-09-22NoNoCurrent
42961-399-074296103990750 PACKET in 1 BOX (42961-399-07) / 2 TABLET in 1 PACKET (42961-399-01) 50 packet2025-09-22NoNoCurrent
42961-399-0842961039908125 PACKET in 1 BOX (42961-399-08) / 2 TABLET in 1 PACKET (42961-399-01) 125 packet2025-09-22NoNoCurrent