FDA.reportPublic FDA data

ACETAMINOPHEN, DIPHENHYDRAMINE HCL

Product NDC
69842-572
11-digit product format
698420572
Labeler code
69842
Product ID
69842-572_374dc81d-eab9-51f1-e063-6294a90ab12f
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HCL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-23
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, DIPHENHYDRAMINE HCL
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
69842-572-02ACETAMINOPHEN, DIPHENHYDRAMINE HCL1 in 1 CARTONTABLET, FILM COATED15
69842-572-02ACETAMINOPHEN, DIPHENHYDRAMINE HCL225 in 1 BOTTLETABLET, FILM COATED2255
69842-572-08ACETAMINOPHEN, DIPHENHYDRAMINE HCL24 in 1 BOTTLETABLET, FILM COATED245
69842-572-08ACETAMINOPHEN, DIPHENHYDRAMINE HCL1 in 1 CARTONTABLET, FILM COATED15
69842-572-12ACETAMINOPHEN, DIPHENHYDRAMINE HCL1 in 1 CARTONTABLET, FILM COATED15
69842-572-12ACETAMINOPHEN, DIPHENHYDRAMINE HCL100 in 1 BOTTLETABLET, FILM COATED1005
69842-572-15ACETAMINOPHEN, DIPHENHYDRAMINE HCL1 in 1 CARTONTABLET, FILM COATED15
69842-572-15ACETAMINOPHEN, DIPHENHYDRAMINE HCL50 in 1 BOTTLETABLET, FILM COATED505
69842-572-29ACETAMINOPHEN, DIPHENHYDRAMINE HCL150 in 1 BOTTLETABLET, FILM COATED1505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-572ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED [CVS PHARMACY, INC.]4Current NDC, Legacy NDC, 9 package rows20240131_6df9a638-09dd-166f-e053-2991aa0a8dd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN6df9a638-09dd-166f-e053-2991aa0a8dd05
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD6df9a638-09dd-166f-e053-2991aa0a8dd05
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY6df9a638-09dd-166f-e053-2991aa0a8dd05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-572-02698420572021 BOTTLE in 1 CARTON (69842-572-02) / 225 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-02-02NoNoHistorical
69842-572-08698420572081 BOTTLE in 1 CARTON (69842-572-08) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-230000-00-00NoNoCurrent
69842-572-12698420572121 BOTTLE in 1 CARTON (69842-572-12) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-230000-00-00NoNoCurrent
69842-572-15698420572151 BOTTLE in 1 CARTON (69842-572-15) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-07-230000-00-00NoNoCurrent
69842-572-2969842057229150 TABLET, FILM COATED in 1 BOTTLE (69842-572-29) 2018-07-230000-00-00NoNoCurrent