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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6fee238-0b6f-cb84-e053-2995a90a361b2024-12-05WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEL.N.K. International, Inc.379ef03c-3b6a-40c3-b736-99f0537d26c82024-12-05WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENMarc Glassman, Inc.43bf297f-2832-424f-a013-4bfa1d6c03e62024-12-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.5a68ab98-720c-479a-a60a-4e594add6c092024-12-04WarningsExact identifier
application number: M013
HEB Effervescent Pain ReliefASPIRINH. E. BUTT GROCERY COMPANY03876c71-60ec-3280-e063-6294a90a62dc2024-12-03WarningsExact identifier
application number: M013
Migrafein FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028875c9-4129-ce2c-e063-6294a90a26cc2024-12-03WarningsExact identifier
application number: M013
Neo-Lubrina FuerteACETAMINOPHEN, CAFFEINEOPMX LLC0288a327-fd4b-1991-e063-6294a90ace502024-12-03WarningsExact identifier
application number: M013
CAFIZETAMOL FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028771d3-a514-f7a5-e063-6394a90ac4f32024-12-03WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC048c4b03-1cf4-b724-e063-6294a90a1cad2024-12-03WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCecd6df7e-e7e2-446b-85ef-25971281fe312024-12-03WarningsExact identifier
application number: M013
Market Basket Effervescent Pain ReliefASPIRINDEMOULAS SUPER MARKETS, INC.08133bf0-3c8f-e4d0-e063-6294a90af79a2024-12-03WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWinCo Foods, LLC4359da13-e851-440b-91b9-6b544bff20d22024-12-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWinCo Foods, LLC5b3e8a78-5357-42ad-811e-b2578b25dc7b2024-12-03WarningsExact identifier
application number: M013
Low Strength Chewable AspirinASPIRINGeri-Care Pharmaceutical Corpcc77b9d1-7874-4ce8-a763-3a0e1c2891de2024-12-03WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association0e3be5f4-bc1b-4b44-a86a-ace89f6ee5922024-12-02WarningsExact identifier
application number: M013
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact 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