FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
70000-0598
11-digit product format
700000598
Labeler code
70000
Product ID
70000-0598_4b434677-8323-4529-e063-6294a90a1616
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-07
Marketing end
2028-02-29
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride

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
70000-0598-1Diphenhydramine Hydrochloride2 in 1 CARTONCAPSULE24
70000-0598-1Diphenhydramine Hydrochloride12 in 1 BLISTER PACKCAPSULE124
70000-0598-2Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0598DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [LEADER/ CARDINAL HEALTH 110, INC.]3Current NDC, Legacy NDC, 3 package rows20250212_e33cbd1d-1848-145a-e053-2995a90aeb50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNe33cbd1d-1848-145a-e053-2995a90aeb504
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDe33cbd1d-1848-145a-e053-2995a90aeb504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0598-1700000598012 BLISTER PACK in 1 CARTON (70000-0598-1) / 12 CAPSULE in 1 BLISTER PACK2 blister pack2022-07-072028-01-31NoNoCurrent
70000-0598-270000059802100 CAPSULE in 1 BOTTLE (70000-0598-2) 100 capsule2022-07-072028-02-29NoNoCurrent