FDA.reportPublic FDA data

Pain Relief PM

Product NDC
61504-095
11-digit product format
615040095
Labeler code
61504
Product ID
61504-095_092d2bb0-6011-4256-e063-6394a90ab2c4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AMERIFOODS TRADING COMPANY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-30
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
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
61504-095-03Pain Relief PM100 in 1 BOTTLE, PLASTICTABLET, COATED1002
61504-095-03Pain Relief PM1 in 1 CARTONTABLET, COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61504-095PAIN RELIEF PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [AMERIFOODS TRADING COMPANY]2Current NDC, 2 package rows20231103_f6dd6396-93e9-1096-e053-6394a90af06d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf6dd6396-93e9-1096-e053-6394a90af06d2
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf6dd6396-93e9-1096-e053-6394a90af06d2
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf6dd6396-93e9-1096-e053-6394a90af06d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
61504-095-03615040095031 BOTTLE, PLASTIC in 1 CARTON (61504-095-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-10-30NoNoCurrent