FDA.reportPublic FDA data

Tylenol PM

Product NDC
53209-1002
Requested package NDC
53209-1002-2
11-digit product format
532091002
Labeler code
53209
Product ID
53209-1002_37e8f74e-9c3f-b0e7-e063-6394a90a5106
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen and diphenhydramine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Morning Star OTC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-19
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
2026-12-31
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
2026-12-31

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
6cd07a01-7034-4994-bbd3-bedcdf7d5b83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53209-1002-1Tylenol PMExtra Strength2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-1002-2Tylenol PMExtra Strength25 in 1 POUCHTABLET, FILM COATED251

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
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY6cd07a01-7034-4994-bbd3-bedcdf7d5b831
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY6cd07a01-7034-4994-bbd3-bedcdf7d5b831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53209-1002-25320910020225 BLISTER PACK in 1 POUCH (53209-1002-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1002-1) 25 blister pack2025-06-19NoNoCurrent