FDA.reportPublic FDA data

Tylenol PM

Product NDC
85237-2945
11-digit product format
852372945
Labeler code
85237
Product ID
85237-2945_55d0dd09-882d-754a-e063-6294a90a15ee
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Select Consumer Group
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-11
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
Tylenol PM
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup
1092378Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55d0dceb-c9a9-778e-e063-6294a90a2ad7Available on FDA.report

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 27 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Pain reliverASPIRINPioneer Life Sciences, LLC8dc29957-2ac1-47f8-89fd-a6bcf97ee3d32025-12-23WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGranules USA, Inca1255f60-b9c6-9a95-e053-2995a90a9e802025-12-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGranules USA, Inca51395ea-e038-dc9c-e053-2a95a90a287d2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Inc1148b4d9-fa6a-49e6-9663-17b2c83738462025-12-22WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Incf4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac2025-12-22WarningsExact identifier
application number: M013
VitapirenaACETAMINOPHENPharmadel LLC0547bc1f-d000-f5a6-e063-6294a90ac73d2025-12-22WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Incc4f82ed8-b82c-47bb-9ab9-108a13d29cf72025-12-22WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc5103450a-3095-49cc-9823-4fb4c1d258ff2025-12-22WarningsExact identifier
application number: M013
CAREALL Non-Aspirin PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc499b2bf8-72fb-4500-b16e-517cab09a8ae2025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc933154b9-c9d6-4260-8775-1c83631c74e42025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
application number: M013
AspirinASPIRINL.N.K. International, Inc.35005045-57b2-4ffe-ab70-22d570c1b1612025-12-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalmart175495fd-c561-f813-e063-6294a90aac802025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-2945-1852372945011 POUCH in 1 BLISTER PACK (85237-2945-1) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 1 pouch2022-06-01NoNoCurrent
85237-2945-2852372945022 POUCH in 1 BLISTER PACK (85237-2945-2) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 2 pouch2022-06-01NoNoCurrent
85237-2945-38523729450320 POUCH in 1 CONTAINER (85237-2945-3) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 20 pouch2022-06-01NoNoCurrent
85237-2945-48523729450425 POUCH in 1 CONTAINER (85237-2945-4) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 25 pouch2022-06-01NoNoCurrent
85237-2945-68523729450650 POUCH in 1 CONTAINER (85237-2945-6) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 50 pouch2022-06-01NoNoCurrent
85237-2945-7852372945073 POUCH in 1 BLISTER PACK (85237-2945-7) / 2 TABLET, FILM COATED in 1 POUCH (85237-2945-0) 3 pouch2022-06-01NoNoCurrent