Tylenol PM

Product NDC
67414-608
11-digit product format
674140608
Labeler code
67414
Product ID
67414-608_20aec2bd-9934-370f-e063-6294a90a2bae
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jones Healthcare Group - Packaging Services, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-25
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
Brand name suffix
Extra Strength
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
67414-608-00Tylenol PM Extra Strength2 in 1 POUCHTABLET, FILM COATED28
67414-608-00Tylenol PM Extra Strength2500 in 1 BOXTABLET, FILM COATED25008
67414-608-06Tylenol PM Extra Strength50 in 1 TRAYTABLET, FILM COATED508
67414-608-06Tylenol PM Extra Strength2 in 1 POUCHTABLET, FILM COATED28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67414-608TYLENOL PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [JONES HEALTHCARE GROUP - PACKAGING SERVICES, INC]8Current NDC, Legacy NDC, 4 package rows20240829_639f4e01-9723-a619-e053-2991aa0a549a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN639f4e01-9723-a619-e053-2991aa0a549a8
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN639f4e01-9723-a619-e053-2991aa0a549a8
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD639f4e01-9723-a619-e053-2991aa0a549a8
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD639f4e01-9723-a619-e053-2991aa0a549a8
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY639f4e01-9723-a619-e053-2991aa0a549a8
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY639f4e01-9723-a619-e053-2991aa0a549a8
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY639f4e01-9723-a619-e053-2991aa0a549a8
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY639f4e01-9723-a619-e053-2991aa0a549a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67414-608-00674140608002500 POUCH in 1 BOX (67414-608-00) / 2 TABLET, FILM COATED in 1 POUCH2500 pouch2018-01-250000-00-00NoNoCurrent
67414-608-066741406080650 POUCH in 1 TRAY (67414-608-06) / 2 TABLET, FILM COATED in 1 POUCH50 pouch2018-01-250000-00-00NoNoCurrent