FDA.reportPublic FDA data

Allergy

Product NDC
76168-121
11-digit product format
761680121
Labeler code
76168
Product ID
76168-121_6c30ec6a-4c24-d604-e053-2a91aa0ac869
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Velocity Pharma LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-05-14
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
Allergy
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
1049630Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
73e4f21c-e5ec-42c9-9ec8-118479857057Available 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
76168-121-12Allergy1 in 1 CARTONTABLET12
76168-121-12Allergy100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-121ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA LLC]2Current NDC, Legacy NDC, 2 package rows20180515_73e4f21c-e5ec-42c9-9ec8-118479857057.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
AllergyDIPHENHYDRAMINE HYDROCHLORIDEVelocity Pharma LLC73e4f21c-e5ec-42c9-9ec8-1184798570572018-05-14WarningsExact identifier
ndc (product): 76168-121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN73e4f21c-e5ec-42c9-9ec8-1184798570572
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD73e4f21c-e5ec-42c9-9ec8-1184798570572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76168-121-1276168012112100 CARTON in 1 BOTTLE (76168-121-12) / 1 TABLET in 1 CARTON100 carton2018-05-140000-00-00NoNoCurrent