FDA.reportPublic FDA data

Tylenol PM

Product NDC
50269-608
11-digit product format
502690608
Labeler code
50269
Product ID
50269-608_09af5277-5a19-3c72-e063-6294a90a704d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
JC World Bell Wholesale Co., Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-16
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

Additional Listing Data#

Finished product
Yes
Brand name base
Tylenol PM
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, TC2D6JAD40
Rxcui1092189, 1092378

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
50269-608-06Tylenol PM25 in 1 BOXTABLET, FILM COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-608TYLENOL PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JC WORLD BELL WHOLESALE CO., INC.]3Current NDC, Legacy NDC, 1 package rows20231109_83df6b68-8bb5-410b-bb97-0a5eecf424f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY83df6b68-8bb5-410b-bb97-0a5eecf424f23
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY83df6b68-8bb5-410b-bb97-0a5eecf424f23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50269-608-065026906080625 TABLET, FILM COATED in 1 BOX (50269-608-06) 2018-08-160000-00-00NoNoCurrent