Diphenhydramine Hydrochloride

Product NDC
55154-9363
11-digit product format
551549363
Labeler code
55154
Product ID
55154-9363_7bf6446b-a127-4c1a-b601-857d786025dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA040466
Marketing category
ANDA
Marketing start
2002-08-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/mL
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 HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1723740

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
55154-9363-5Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION, SOLUTION112
55154-9363-5Diphenhydramine Hydrochloride5 in 1 BAGINJECTION, SOLUTION512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55154-9363-5ML - Milliliter55154-9363eb51d5b0-25c7-4668-ba3e-5ab4cc35422012020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
diphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9363DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, SOLUTION [CARDINAL HEALTH 107, LLC]12Current NDC, Legacy NDC, 2 package rows20250503_50df93bf-fe72-48f6-a02e-ea9a313d47c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN50df93bf-fe72-48f6-a02e-ea9a313d47c212
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD50df93bf-fe72-48f6-a02e-ea9a313d47c212
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY50df93bf-fe72-48f6-a02e-ea9a313d47c212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-9363-5551549363055 VIAL in 1 BAG (55154-9363-5) / 1 mL in 1 VIAL5 vial2002-08-010000-00-00NoNoCurrent