FDA.reportPublic FDA data

Acetaminophen PM

Product NDC
41520-956
11-digit product format
415200956
Labeler code
41520
Product ID
41520-956_f65e2b45-16d7-4186-a2e6-6d0e8724a723
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
FOODHOLD U.S.A., LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-17
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
Acetaminophen 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
41520-956-09Acetaminophen PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED2013
41520-956-09Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED113
41520-956-31Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED113
41520-956-31Acetaminophen PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-956ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [FOODHOLD U.S.A., LLC]12Current NDC, Legacy NDC, 4 package rows20240920_fdd7ce80-d6be-41b9-affd-d024cf306b50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNfdd7ce80-d6be-41b9-affd-d024cf306b5013
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDfdd7ce80-d6be-41b9-affd-d024cf306b5013
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYfdd7ce80-d6be-41b9-affd-d024cf306b5013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
41520-956-09415200956091 BOTTLE, PLASTIC in 1 CARTON (41520-956-09) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
41520-956-31415200956311 BOTTLE, PLASTIC in 1 CARTON (41520-956-31) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent