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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049909Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e66c626-607f-4558-ab2e-2dd9a25f7be4Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEAdvance Pharmaceutical Inc.4e66c626-607f-4558-ab2e-2dd9a25f7be42017-12-22WarningsExact identifier
ndc (product): 17714-020

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