Diphenhydramine HCl

Product NDC
73376-003
11-digit product format
733760003
Labeler code
73376
Product ID
73376-003_47e64690-d754-1ea9-e063-6394a90a1499
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
INVAHEALTH INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-07-28
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/25mg
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/25mg

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049630

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
73376-003-80Diphenhydramine HCl1000 mg in 1 BOTTLETABLET, FILM COATED10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73376-003DIPHENHYDRAMINE HCL TABLET, FILM COATED [INVAHEALTH INC]2Current NDC, Legacy NDC, 1 package rows20240110_e4e4004f-77e3-569d-e053-2a95a90a73fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNe4e4004f-77e3-569d-e053-2a95a90a73fe3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDe4e4004f-77e3-569d-e053-2a95a90a73fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73376-003-80733760003801000 mg in 1 BOTTLE (73376-003-80) 1000 mg2022-07-280000-00-00NoNoCurrent