FDA.reportPublic FDA data

Acetaminophen, Diphenhydramine Hydrochloride

Product NDC
70000-0411
11-digit product format
700000411
Labeler code
70000
Product ID
70000-0411_4bbe57b4-c0c6-c37f-e063-6294a90a7dd7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-29
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, Diphenhydramine Hydrochloride
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
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-1Acetaminophen, Diphenhydramine Hydrochloride24 in 1 BOTTLETABLET, FILM COATED247
70000-0411-2Acetaminophen, Diphenhydramine Hydrochloride50 in 1 BOTTLETABLET, FILM COATED507
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride1 in 1 CARTONTABLET, FILM COATED17
70000-0411-3Acetaminophen, Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0411-1EA - Each70000-041115fd30a1-2ad7-436f-be92-9b92e7c98b6712019-08-06
70000-0411-2EA - Each70000-041138d72d75-ca00-495d-ba2f-f47c8f99fd2112019-08-06
70000-0411-3EA - Each70000-041188c57048-0046-45d5-8256-8d2dfb5493ff12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0411ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE TABLET, FILM COATED [LEADER/ CARDINAL HEALTH 110, INC.]6Current NDC, Legacy NDC, 5 package rows20250212_7be4d67e-1af9-f059-e053-2991aa0a382e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN7be4d67e-1af9-f059-e053-2991aa0a382e7
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD7be4d67e-1af9-f059-e053-2991aa0a382e7
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY7be4d67e-1af9-f059-e053-2991aa0a382e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0411-1700000411011 BOTTLE in 1 CARTON (70000-0411-1) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-100000-00-00NoNoCurrent
70000-0411-27000004110250 TABLET, FILM COATED in 1 BOTTLE (70000-0411-2) 2018-11-290000-00-00NoNoCurrent
70000-0411-3700000411031 BOTTLE in 1 CARTON (70000-0411-3) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-100000-00-00NoNoCurrent