FDA.reportPublic FDA data

Acetaminophen and Diphenhydramine HCL

Product NDC
21130-661
11-digit product format
211300661
Labeler code
21130
Product ID
21130-661_4650a298-b556-8c7e-e063-6394a90a01db
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCL
Dosage form
TABLET
Route
ORAL
Labeler
SAFEWAY
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-30
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 and 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
21130-661-10Acetaminophen and Diphenhydramine HCL100 in 1 BOTTLETABLET1007
21130-661-20Acetaminophen and Diphenhydramine HCL200 in 1 BOTTLETABLET2007
21130-661-24Acetaminophen and Diphenhydramine HCL24 in 1 BOTTLETABLET247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-661ACETAMINOPHEN AND DIPHENHYDRAMINE HCL TABLET [SAFEWAY]6Current NDC, 3 package rows20241218_f18c1aa2-5f8b-5458-e053-2995a90ab947.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSNf18c1aa2-5f8b-5458-e053-2995a90ab9477
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCDf18c1aa2-5f8b-5458-e053-2995a90ab9477
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSYf18c1aa2-5f8b-5458-e053-2995a90ab9477

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-661-1021130066110100 TABLET in 1 BOTTLE (21130-661-10) 100 tablet2023-06-30NoNoHistorical
21130-661-2021130066120200 TABLET in 1 BOTTLE (21130-661-20) 200 tablet2023-06-30NoNoHistorical
21130-661-242113006612424 TABLET in 1 BOTTLE (21130-661-24) 24 tablet2023-06-30NoNoHistorical