FDA.reportPublic FDA data

Acetaminophen Diphenhydramine HCL

Product NDC
0363-9661
11-digit product format
003639661
Labeler code
0363
Product ID
0363-9661_46545016-29d1-7e81-e063-6294a90a941f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Diphenhydramine HCL
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-23
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE
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
DIPHENHYDRAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 8GTS82S83M
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
0363-9661-15Acetaminophen Diphenhydramine HCL150 in 1 BOTTLETABLET1504
0363-9661-25Acetaminophen Diphenhydramine HCL250 in 1 BOTTLETABLET2504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9661ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [WALGREENS]3Current NDC, 2 package rows20241222_fd7c3250-35d4-494a-e053-6394a90a2db5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNfd7c3250-35d4-494a-e053-6394a90a2db54
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDfd7c3250-35d4-494a-e053-6394a90a2db54
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYfd7c3250-35d4-494a-e053-6394a90a2db54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9661-1500363966115150 TABLET in 1 BOTTLE (0363-9661-15) 150 tablet2024-07-23NoNoHistorical
0363-9661-2500363966125250 TABLET in 1 BOTTLE (0363-9661-25) 250 tablet2024-07-23NoNoHistorical