CAREALL Pain Relief PM

Product NDC
51824-108
11-digit product format
518240108
Labeler code
51824
Product ID
51824-108_46904fee-90b9-5c63-e063-6394a90ac2fc
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
New World Imports, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-23
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
CAREALL Pain Relief 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

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
51824-108-50CAREALL Pain Relief PMExtra Strength50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-108CAREALL PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET [NEW WORLD IMPORTS, INC]1Current NDC, 1 package rows20240824_933154b9-c9d6-4260-8775-1c83631c74e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN933154b9-c9d6-4260-8775-1c83631c74e42
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD933154b9-c9d6-4260-8775-1c83631c74e42
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY933154b9-c9d6-4260-8775-1c83631c74e42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-108-505182401085050 TABLET in 1 BOTTLE (51824-108-50) 50 tablet2024-08-23NoNoHistorical