Diphenhydramine Hydrochloride

Product NDC
17714-135
11-digit product format
177140135
Labeler code
17714
Product ID
17714-135_60f4322f-5c99-096a-e053-2a91aa0a64eb
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Advance Pharmaceutical Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-09-26
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
Rxcui1049630

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
17714-135-01Diphenhydramine Hydrochloride100 in 1 BOTTLETABLET1002

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KDIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-135DIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 1 package rows20171223_c80f9a4c-1055-45d2-8fde-5b57fad3c82a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNc80f9a4c-1055-45d2-8fde-5b57fad3c82a2
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDc80f9a4c-1055-45d2-8fde-5b57fad3c82a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17714-135-0117714013501100 TABLET in 1 BOTTLE (17714-135-01) 100 tablet2006-09-260000-00-00NoNoCurrent