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 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
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

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