Diphenhydramine Hydrochloride

Product NDC
55154-5102
11-digit product format
551545102
Labeler code
55154
Product ID
55154-5102_73e2929d-3cb1-40ca-a471-10046cd49e91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cardinal Health 107, LLC
Application
ANDA080817
Marketing category
ANDA
Marketing start
2011-06-28
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049633

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
55154-5102-5Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION116
55154-5102-5Diphenhydramine Hydrochloride5 in 1 BAGINJECTION516

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
diphenhydramineACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
benzethonium chlorideINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
hydrochloric acidINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
sodium hydroxideINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4
waterINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5102DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC]15Current NDC, Legacy NDC, 2 package rows20250507_d32d074a-f1b6-4a9a-8e10-e19f0e67c61b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5102-5551545102055 VIAL in 1 BAG (55154-5102-5) / 1 mL in 1 VIAL5 vial2011-06-280000-00-00NoNoCurrent