Acetaminophen Diphenhydramine HCL

Product NDC
0363-9799
11-digit product format
003639799
Labeler code
0363
Product ID
0363-9799_4653cf42-f61c-31a9-e063-6394a90a00a8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Diphenhydramine HCL
Dosage form
TABLET
Route
ORAL
Labeler
WALGREEN CO.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-03
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
0363-9799-75Acetaminophen Diphenhydramine HCL75 in 1 BOTTLETABLET755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9799ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREEN CO.]4Current NDC, 1 package rows20241218_b3763182-2428-155a-e053-2995a90ab578.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNb3763182-2428-155a-e053-2995a90ab5785
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDb3763182-2428-155a-e053-2995a90ab5785
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYb3763182-2428-155a-e053-2995a90ab5785

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9799-750036397997575 TABLET in 1 BOTTLE (0363-9799-75) 75 tablet2023-03-03NoNoHistorical