FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
54257-278
11-digit product format
542570278
Labeler code
54257
Product ID
54257-278_08bf29ff-1c79-1547-e063-6294a90ac7ee
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Magno-Humphries, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-24
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 Reliever 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

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
54257-278-02Pain Reliever PM100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54257-278PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [MAGNO-HUMPHRIES, INC.]4Current NDC, Legacy NDC, 1 package rows20231030_9d2275c8-0c3d-d2b3-e053-2995a90a368e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN9d2275c8-0c3d-d2b3-e053-2995a90a368e4
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD9d2275c8-0c3d-d2b3-e053-2995a90a368e4
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY9d2275c8-0c3d-d2b3-e053-2995a90a368e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54257-278-0254257027802100 TABLET in 1 BOTTLE (54257-278-02) 100 tablet2020-01-240000-00-00NoNoCurrent