Diphenhydramine Hydrochloride

Product NDC
0363-8350
11-digit product format
003638350
Labeler code
0363
Product ID
0363-8350_1134343b-ae9d-7a46-e063-6394a90a9e43
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Walgreen Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2026-12-31

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
0363-8350-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1003
0363-8350-01Diphenhydramine Hydrochloride1 in 1 CARTONCAPSULE13
0363-8350-02Diphenhydramine Hydrochloride600 in 1 BOTTLECAPSULE6003
0363-8350-06Diphenhydramine Hydrochloride365 in 1 BOTTLECAPSULE3653

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-8350DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [WALGREEN COMPANY]3Current NDC, 4 package rows20240214_d9f650b5-3c27-17cf-e053-2995a90af48a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNd9f650b5-3c27-17cf-e053-2995a90af48a3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDd9f650b5-3c27-17cf-e053-2995a90af48a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-8350-01003638350011 BOTTLE in 1 CARTON (0363-8350-01) / 100 CAPSULE in 1 BOTTLE1 bottle2024-02-02NoNoCurrent
0363-8350-0200363835002600 CAPSULE in 1 BOTTLE (0363-8350-02) 600 capsule2022-10-17NoNoCurrent
0363-8350-0600363835006365 CAPSULE in 1 BOTTLE (0363-8350-06) 365 capsule2022-08-12NoNoCurrent