Pain Relief PM

Product NDC
50804-825
11-digit product format
508040825
Labeler code
50804
Product ID
50804-825_24c359e6-7a74-0123-e063-6394a90a0f4c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
GoodSense
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
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
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
50804-825-02Pain Relief PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED205
50804-825-02Pain Relief PMExtra Strength1 in 1 CARTONTABLET, COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-825-02EA - Each50804-825f9d74049-b6ad-4d04-a07e-eb5596f320e012022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-825PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [GOODSENSE]5Current NDC, Legacy NDC, 2 package rows20241020_8972d95a-51da-40b5-8ef1-9dfed220d7eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN8972d95a-51da-40b5-8ef1-9dfed220d7eb5
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD8972d95a-51da-40b5-8ef1-9dfed220d7eb5
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY8972d95a-51da-40b5-8ef1-9dfed220d7eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50804-825-02508040825021 BOTTLE, PLASTIC in 1 CARTON (50804-825-02) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2017-08-010000-00-00NoNoCurrent