FDA.reportPublic FDA data

Acetaminophen PM

Product NDC
69842-956
11-digit product format
698420956
Labeler code
69842
Product ID
69842-956_47ca6770-e94f-4ccf-ac53-ddbccfd93d22
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
CVS PHARMACY
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen PM
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

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
69842-956-09Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED112
69842-956-09Acetaminophen PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED2012
69842-956-13Acetaminophen PMExtra Strength250 in 1 BOTTLETABLET, COATED25012
69842-956-31Acetaminophen PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-956ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 4 package rows20250327_67a190c3-7de0-4f57-be94-d6b8285e1220.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN67a190c3-7de0-4f57-be94-d6b8285e122012
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD67a190c3-7de0-4f57-be94-d6b8285e122012
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY67a190c3-7de0-4f57-be94-d6b8285e122012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-956-09698420956091 BOTTLE, PLASTIC in 1 CARTON (69842-956-09) > 20 TABLET in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
69842-956-1369842095613250 in 1 BOTTLEHistorical
69842-956-316984209563180 TABLET, COATED in 1 BOTTLE, PLASTIC (69842-956-31) 2007-12-170000-00-00NoNoCurrent