FDA.reportPublic FDA data

Pain Reliever PM

Product NDC
59726-868
11-digit product format
597260868
Labeler code
59726
Product ID
59726-868_fd04bd61-2bce-4ec0-99b0-ebd0995d3aba
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Diphenhydramine HCL
Dosage form
TABLET, COATED
Route
ORAL
Labeler
P & L Development, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
Marketing end
2026-12-26
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Reliever PM
Brand name suffix
extra strength

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
59726-868-10Pain Reliever PMextra strength100 in 1 BOTTLE, PLASTICTABLET, COATED1007
59726-868-10Pain Reliever PMextra strength1 in 1 BOXTABLET, COATED17
59726-868-24Pain Reliever PMextra strength1 in 1 BOXTABLET, COATED17
59726-868-24Pain Reliever PMextra strength24 in 1 BOTTLE, PLASTICTABLET, COATED247
59726-868-50Pain Reliever PMextra strength1 in 1 BOXTABLET, COATED17
59726-868-50Pain Reliever PMextra strength50 in 1 BOTTLE, PLASTICTABLET, COATED507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-868PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN DIPHENHYDRAMINE HCL) TABLET, COATED [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 6 package rows20240805_90eba2e8-52c3-43f5-ba93-4a520368c7f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN90eba2e8-52c3-43f5-ba93-4a520368c7f47
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD90eba2e8-52c3-43f5-ba93-4a520368c7f47
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY90eba2e8-52c3-43f5-ba93-4a520368c7f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-868-10597260868101 BOTTLE, PLASTIC in 1 BOX (59726-868-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2021-03-262026-12-26NoNoCurrent
59726-868-24597260868241 BOTTLE, PLASTIC in 1 BOX (59726-868-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2021-03-262026-12-26NoNoHistorical
59726-868-50597260868501 BOTTLE, PLASTIC in 1 BOX (59726-868-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2021-03-262026-12-26NoNoCurrent