FDA.reportPublic FDA data

Lil Drug Store Tylenol PM Extra Strength

Product NDC
66715-9817
11-digit product format
667159817
Labeler code
66715
Product ID
66715-9817_459f9062-e920-d327-e063-6394a90acc1d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-20
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
Lil Drug Store Tylenol PM 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
UniiTC2D6JAD40, 362O9ITL9D
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
66715-9817-2Lil Drug Store Tylenol PM Extra Strength2 in 1 CARTONTABLET, FILM COATED211
66715-9817-2Lil Drug Store Tylenol PM Extra Strength2 in 1 POUCHTABLET, FILM COATED211
66715-9817-3Lil Drug Store Tylenol PM Extra Strength3 in 1 CARTONTABLET, FILM COATED311
66715-9817-3Lil Drug Store Tylenol PM Extra Strength2 in 1 POUCHTABLET, FILM COATED211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9817LIL DRUG STORE TYLENOL PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED TYLENOL PM EXTRA STRENGTH, CVP HEALTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, Legacy NDC, 4 package rows20241124_643371f2-e330-441e-8932-b3aec4b179d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN643371f2-e330-441e-8932-b3aec4b179d211
1092378Tylenol PM 500 MG / 25 MG Oral TabletPSN643371f2-e330-441e-8932-b3aec4b179d211
1092378acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet [Tylenol PM]SBD643371f2-e330-441e-8932-b3aec4b179d211
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD643371f2-e330-441e-8932-b3aec4b179d211
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY643371f2-e330-441e-8932-b3aec4b179d211
1092378APAP 500 MG / Diphenhydramine Hydrochloride 25 MG Oral Tablet [Tylenol PM]SY643371f2-e330-441e-8932-b3aec4b179d211
1092378Tylenol PM (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY643371f2-e330-441e-8932-b3aec4b179d211
1092378Tylenol PM Extra Strength (APAP 500 MG / diphenhydramine hydrochloride 25 MG) Oral TabletSY643371f2-e330-441e-8932-b3aec4b179d211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9817-2667159817022 POUCH in 1 CARTON (66715-9817-2) / 2 TABLET, FILM COATED in 1 POUCH2 pouch2017-10-200000-00-00NoNoCurrent
66715-9817-3667159817033 POUCH in 1 CARTON (66715-9817-3) / 2 TABLET, FILM COATED in 1 POUCH3 pouch2019-08-150000-00-00NoNoCurrent