FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE

Product NDC
0121-0978
11-digit product format
001210978
Labeler code
0121
Product ID
0121-0978_b7eb09fa-58fb-4c3f-ad65-a04965bc52b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA087513
Marketing category
ANDA
Marketing start
1982-02-10
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/10mL
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/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0978-00DIPHENHYDRAMINE HYDROCHLORIDE10 in 1 TRAYSOLUTION1012
0121-0978-00DIPHENHYDRAMINE HYDROCHLORIDE10 in 1 CASESOLUTION1012
0121-0978-10DIPHENHYDRAMINE HYDROCHLORIDE10 mL in 1 CUP, UNIT-DOSESOLUTION1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0978-00ML - Milliliter0121-097850dfe608-97bc-4c81-bf8d-cd2ef338cd1c12017-07-07
0121-0978-10ML - Milliliter0121-0978bf6a2c6b-f01b-4d11-beb4-f418e91f1cac12017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0978DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]12Current NDC, Legacy NDC, 3 package rows20240410_6fe6fe2d-4405-4e7a-a2ed-5eb367d52842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSN6fe6fe2d-4405-4e7a-a2ed-5eb367d5284212
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCD6fe6fe2d-4405-4e7a-a2ed-5eb367d5284212
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSY6fe6fe2d-4405-4e7a-a2ed-5eb367d5284212
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSY6fe6fe2d-4405-4e7a-a2ed-5eb367d5284212
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSY6fe6fe2d-4405-4e7a-a2ed-5eb367d5284212
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbf7ab250-38b0-ba29-e053-2a95a90a8f322
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbf7ab250-38b0-ba29-e053-2a95a90a8f322
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbf7ab250-38b0-ba29-e053-2a95a90a8f322
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbf7ab250-38b0-ba29-e053-2a95a90a8f322
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbf7ab250-38b0-ba29-e053-2a95a90a8f322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0978-000012109780010 TRAY in 1 CASE (0121-0978-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-0978-10) 10 tray1982-02-100000-00-00NoNoCurrent
0121-0978-100012109781010 mL in 1 CUP, UNIT-DOSE10 mlHistorical