Diphenhydramine Hydrochloride

Product NDC
17714-020
11-digit product format
177140020
Labeler code
17714
Product ID
17714-020_60f4322f-5ca5-096a-e053-2a91aa0a64eb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Advance Pharmaceutical Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1989-09-12
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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
17714-020-01Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE1006
17714-020-10Diphenhydramine Hydrochloride1000 in 1 BOTTLECAPSULE10006

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-020DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [ADVANCE PHARMACEUTICAL INC.]6Current NDC, Legacy NDC, 2 package rows20171223_4e66c626-607f-4558-ab2e-2dd9a25f7be4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4e66c626-607f-4558-ab2e-2dd9a25f7be46
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4e66c626-607f-4558-ab2e-2dd9a25f7be46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17714-020-0117714002001100 CAPSULE in 1 BOTTLE (17714-020-01) 100 capsule1989-09-120000-00-00NoNoCurrent
17714-020-10177140020101000 CAPSULE in 1 BOTTLE (17714-020-10) 1000 capsule1989-09-120000-00-00NoNoCurrent