Extra Strength Acetaminophen PM

Product NDC
41226-043
11-digit product format
412260043
Labeler code
41226
Product ID
41226-043_5a1959e3-ff81-a0b4-e063-6394a90a356a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Kroger
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-15
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Extra Strength Acetaminophen PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

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 59 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Regular StrengthACETAMINOPHENMARC GLASSMAN, INC.e21e821c-9694-5db0-e053-2995a90ad0342024-10-22WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENMARC GLASSMAN, INC.e21e90e8-b9f1-1133-e053-2995a90a664b2024-10-22WarningsExact identifier
application number: M013
aspirinASPIRINPublix Super Markets Incc51dae48-aa49-4926-b04a-0da264e08dfa2024-10-22WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb96a2280-ec4f-7c61-e053-2995a90a18bb2024-10-22WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHEBf17a18b0-a7c2-4c64-868c-460cf34e1f7d2024-10-21WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENHEB0863aeaa-15ec-4c67-ba79-4dad54555bd22024-10-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAmerican Health Packaging3c0175a0-175b-48b8-9192-3f869690c0f22024-10-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAmerican Health Packaging0d6553bd-3e18-4624-a83a-899bcafb32722024-10-21WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral SuspensionACETAMINOPHENAmerican Health Packaging8231dd91-e9e6-4350-a485-fa95d65a6d252024-10-21WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYcf63c372-acdd-6e6e-e053-2995a90a16622024-10-21WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENL. Perrigo Company8b56bfc0-2253-458d-99a6-0b0f9ae0ba502024-10-21WarningsExact identifier
application number: M013
AspirinASPIRINGOODSENSE662a2bc6-9507-465c-b467-7ae1b2e1dedc2024-10-18WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENGoodSenseda4339c0-1822-41d8-8c20-214c379a5aa72024-10-18WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGoodSense8972d95a-51da-40b5-8ef1-9dfed220d7eb2024-10-18WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENAmeriSource Bergend571f520-a56e-4f7f-9214-d89197f742b62024-10-18WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepack6b4b7f72-dac8-4b59-a58c-7c59d4b1ef322024-10-18WarningsExact identifier
application number: M013
dg health pain reliefACETAMINOPHENDolgencorp Inc2e1470f5-e88f-4d1d-a308-170f7080387e2024-10-17WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART146c735b-5081-4de4-9025-d939d560bbba2024-10-17WarningsExact identifier
application number: M013
Chewable AspirinASPIRINDISCOUNT DRUG MARTc8483d64-874c-3056-e053-2995a90ad8aa2024-10-17WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINDISCOUNT DRUG MARTc8484998-e0e1-ffce-e053-2995a90aa7de2024-10-17WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-043-20412260043202 BOTTLE in 1 CARTON (41226-043-20) / 100 TABLET in 1 BOTTLE (41226-043-01) 2 bottle2026-09-15NoNoCurrent