Diphenhydramine Hydrochloride

Product NDC
17714-023
11-digit product format
177140023
Labeler code
17714
Product ID
17714-023_5cc9196c-68d7-c9c1-e053-2a91aa0acd8b
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
2012-09-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
1085945Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1f51b7b-da65-4637-8199-f7d59e6dd1c1Available 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
17714-023-50Diphenhydramine Hydrochloride50 in 1 BOTTLETABLET502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17714-023DIPHENHYDRAMINE HYDROCHLORIDE TABLET [ADVANCE PHARMACEUTICAL INC.]2Current NDC, Legacy NDC, 1 package rows20171031_d1f51b7b-da65-4637-8199-f7d59e6dd1c1.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.d1f51b7b-da65-4637-8199-f7d59e6dd1c12017-10-30WarningsExact identifier
ndc (product): 17714-023

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1085945diphenhydrAMINE HCl 50 MG Oral TabletPSNd1f51b7b-da65-4637-8199-f7d59e6dd1c12
1085945diphenhydramine hydrochloride 50 MG Oral TabletSCDd1f51b7b-da65-4637-8199-f7d59e6dd1c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17714-023-501771400235050 TABLET in 1 BOTTLE (17714-023-50) 50 tablet2012-09-010000-00-00NoNoCurrent