Pain Reliever PM

Product NDC
36800-466
11-digit product format
368000466
Labeler code
36800
Product ID
36800-466_a9dfaecc-0044-44bd-8b53-e6e02f4ed626
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-05
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
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
36800-466-10Pain Reliever PMExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1008
36800-466-10Pain Reliever PMExtra Strength1 in 1 BOXTABLET, COATED18
36800-466-50Pain Reliever PMExtra Strength1 in 1 BOXTABLET, COATED18
36800-466-50Pain Reliever PMExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-466PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]8Current NDC, Legacy NDC, 4 package rows20250228_923b443d-73cc-4c52-92e4-a075786b1ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN923b443d-73cc-4c52-92e4-a075786b1ae38
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD923b443d-73cc-4c52-92e4-a075786b1ae38
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY923b443d-73cc-4c52-92e4-a075786b1ae38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-466-10368000466101 BOTTLE, PLASTIC in 1 BOX (36800-466-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2021-11-050000-00-00NoNoCurrent
36800-466-50368000466501 BOTTLE, PLASTIC in 1 BOX (36800-466-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2021-11-050000-00-00NoNoCurrent