Diphenhydramine HCL

Product NDC
50090-5744
11-digit product format
500905744
Labeler code
50090
Product ID
50090-5744_5d836ba9-72af-47bc-a8c5-8efcc8ea457c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 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
Diphenhydramine HCL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5744-12023-02-06C16284748780-1f386c649-d729-0266-e053-dadaa90a7c1aDrug Facts
50090-5744-12023-02-06C16284748780-1f386c649-d729-0266-e053-dadaa90a7c1aDrug Facts
50090-5744-12023-01-30C16284748780-1f386c649-d729-0266-e053-dadaa90a7c1aDrug Facts
50090-5744-12023-01-30C16284748780-1f386c649-d729-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5744-1Diphenhydramine HCL28 in 1 BOTTLECAPSULE288

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5744DIPHENHYDRAMINE HCL CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 1 package rows20231205_a5809774-ed52-4f54-b48e-888631e0223d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa5809774-ed52-4f54-b48e-888631e0223d8
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa5809774-ed52-4f54-b48e-888631e0223d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5744-15009057440128 CAPSULE in 1 BOTTLE (50090-5744-1) 28 capsule2021-09-290000-00-00NoNoCurrent