Diphenhydramine HCL

Product NDC
50090-5716
11-digit product format
500905716
Labeler code
50090
Product ID
50090-5716_b0e79b60-022d-43de-8cbe-7ed2b46bb3ed
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5716-0Diphenhydramine HCL30 in 1 BOTTLECAPSULE308
50090-5716-3Diphenhydramine HCL20 in 1 BOTTLECAPSULE208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5716-0EA - Each50090-57163ccd1aed-1597-439f-af28-ed053f69e77212023-08-08
50090-5716-3EA - Each50090-5716b274d2e2-f29f-4c09-a582-94812cf91df712024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5716DIPHENHYDRAMINE HCL CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20231205_5767f546-a751-4583-a8b7-971175c27ef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5767f546-a751-4583-a8b7-971175c27ef08
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5767f546-a751-4583-a8b7-971175c27ef08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5716-05009057160030 CAPSULE in 1 BOTTLE (50090-5716-0) 30 capsule2021-09-240000-00-00NoNoCurrent
50090-5716-35009057160320 CAPSULE in 1 BOTTLE (50090-5716-3) 20 capsule2022-07-020000-00-00NoNoCurrent