FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
0641-0376
11-digit product format
006410376
Labeler code
0641
Product ID
0641-0376_a26a0df5-fdb8-4c50-ac01-8ae033578bf0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diphenhydramine hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA080817
Marketing category
ANDA
Marketing start
1972-11-27
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
Rxcui1049633

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
3aa5a017-61e9-0c89-adef-13e7964d22f0Product name320171208
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
00358076-c817-430b-b924-11d717dc307cProduct name120160718
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-0376-21Diphenhydramine Hydrochloride1 mL in 1 VIALINJECTION112
0641-0376-25Diphenhydramine Hydrochloride25 in 1 PACKAGEINJECTION2512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-0376-21ML - Milliliter0641-03768c8139e5-8f02-4c81-87c2-2d319fdbd59412012-07-24
0641-0376-25ML - Milliliter0641-0376a1a960fe-d7c4-417f-91de-2ef619a68ff912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]7
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
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [TYA PHARMACEUTICALS]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
BENZETHONIUM CHLORIDEINACTIVE INGREDIENTPH41D05744DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HYDROCHLORIDE INJECTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-0376DIPHENHYDRAMINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]12Current NDC, Legacy NDC, 2 package rows20240410_ec691492-a295-4b48-a1a3-5824931efa97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN5af966ae-535b-492b-ba2c-eeb4e40be95916
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN62edde3d-b41b-40fc-ac18-b749035de83116
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD5af966ae-535b-492b-ba2c-eeb4e40be95916
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD62edde3d-b41b-40fc-ac18-b749035de83116
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY5af966ae-535b-492b-ba2c-eeb4e40be95916
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYd32d074a-f1b6-4a9a-8e10-e19f0e67c61b16
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY62edde3d-b41b-40fc-ac18-b749035de83116
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNec691492-a295-4b48-a1a3-5824931efa9712
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDec691492-a295-4b48-a1a3-5824931efa9712
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYec691492-a295-4b48-a1a3-5824931efa9712
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSN738f2ce3-520c-b3a2-e053-2a91aa0af3247
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCD738f2ce3-520c-b3a2-e053-2a91aa0af3247
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSY738f2ce3-520c-b3a2-e053-2a91aa0af3247
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDeedb421c-0020-4e5f-8b09-26a1cbabb6816
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYeedb421c-0020-4e5f-8b09-26a1cbabb6816
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSNbae7a52f-504b-416e-afdd-e6853e2d59445
212033aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874BAYER Aspirin 325 MG Oral TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1723740diphenhydrAMINE HCl 50 MG in 1 ML InjectionPSNaf972e71-62ab-40c6-925a-cbcb4d6720a45
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletPSNbae7a52f-504b-416e-afdd-e6853e2d59445
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBDbae7a52f-504b-416e-afdd-e6853e2d59445
17237401 ML diphenhydramine hydrochloride 50 MG/ML InjectionSCDaf972e71-62ab-40c6-925a-cbcb4d6720a45
212033aspirin 325 MG Oral TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCDbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4000 MG Chewable TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 0.4 MG Sublingual TabletSCDbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSYbae7a52f-504b-416e-afdd-e6853e2d59445
212033ASA 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SYbae7a52f-504b-416e-afdd-e6853e2d59445
211874Bayer Aspirin 325 MG Oral TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1723740diphenhydramine HCl 50 MG per 1 ML InjectionSYaf972e71-62ab-40c6-925a-cbcb4d6720a45
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYbae7a52f-504b-416e-afdd-e6853e2d59445
310519glucose 4 GM Chewable TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039nitroglycerin 400 MCG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039NTG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
198039TNG 0.4 MG Sublingual TabletSYbae7a52f-504b-416e-afdd-e6853e2d59445
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilPSN58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874BAYER Aspirin 325 MG Oral TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydrAMINE HCl 50 MG/ML Injectable SolutionPSN58d78805-3e8c-4859-b2e0-e3089f9252804
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSN58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletPSN58d78805-3e8c-4859-b2e0-e3089f9252804
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD58d78805-3e8c-4859-b2e0-e3089f9252804
212033aspirin 325 MG Oral TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine hydrochloride 50 MG/ML Injectable SolutionSCD58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4000 MG Chewable TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose InhalerSCD58d78805-3e8c-4859-b2e0-e3089f9252804
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 0.4 MG Sublingual TabletSCD58d78805-3e8c-4859-b2e0-e3089f9252804
2123111albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProventilSY58d78805-3e8c-4859-b2e0-e3089f9252804
212033ASA 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY58d78805-3e8c-4859-b2e0-e3089f9252804
211874Bayer Aspirin 325 MG Oral TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
1049633diphenhydramine HCl 50 MG/ML Injectable SolutionSY58d78805-3e8c-4859-b2e0-e3089f9252804
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSY58d78805-3e8c-4859-b2e0-e3089f9252804
310519glucose 4 GM Chewable TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039nitroglycerin 400 MCG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039NTG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
198039TNG 0.4 MG Sublingual TabletSY58d78805-3e8c-4859-b2e0-e3089f9252804
313782acetaminophen 325 MG Oral TabletPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123076albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for VentolinPSN9ef8edbd-047a-40fe-a603-d71fce8ada683
2123072albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAirPSN9ef8edbd-047a-40fe-a603-d71fce8ada683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-0376-21006410376211 mL in 1 VIAL1 mlHistorical
0641-0376-250064103762525 VIAL in 1 PACKAGE (0641-0376-25) / 1 mL in 1 VIAL (0641-0376-21) 25 vial1972-11-270000-00-00NoNoCurrent