Diphenhydramine HCl

Product NDC
68788-8274
11-digit product format
687888274
Labeler code
68788
Product ID
68788-8274_32532b11-59a5-4d31-8206-5a9fc2b76f45
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-14
Marketing end
2027-04-29
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/5mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diphenhydramine HCl

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049906

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
68788-8274-1Diphenhydramine HCl118 mL in 1 BOTTLE, PLASTICSOLUTION1185

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8274DIPHENHYDRAMINE HCL SOLUTION [PREFERRED PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20250331_d3f769d7-3cbb-4469-bff8-2015619ee115.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049906diphenhydrAMINE HCl 12.5 MG in 5 mL Oral SolutionPSNd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 2.5 MG/ML Oral SolutionSCDd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine HCl 12.5 MG per 5 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 25 MG per 10 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155
1049906diphenhydramine hydrochloride 50 MG per 20 ML Oral SolutionSYd3f769d7-3cbb-4469-bff8-2015619ee1155

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8274-168788827401118 mL in 1 BOTTLE, PLASTIC (68788-8274-1) 118 ml2022-10-142027-04-29NoNoCurrent