Allergy

Product NDC
76168-013
11-digit product format
761680013
Labeler code
76168
Product ID
76168-013_43b59cca-632b-5ff3-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Velocity Pharma
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-05-12
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-013-072020-01-31C16284748780-19d75b9d0-444d-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 25mg, USP
76168-013-122020-01-31C16284748780-19d75b9d0-444d-f424-e053-dadaa90a57ceDIPHENHYDRAMINE HCl 25mg, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-013-07Allergy36 in 1 BOTTLETABLET363
76168-013-07Allergy1 in 1 CARTONTABLET13
76168-013-12Allergy1 in 1 CARTONTABLET13
76168-013-12Allergy100 in 1 BOTTLETABLET1003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-013ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [VELOCITY PHARMA]3Legacy NDC, 4 package rows20161215_08bff194-0ae9-4df6-a4a1-e4661c3bfad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN08bff194-0ae9-4df6-a4a1-e4661c3bfad73
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD08bff194-0ae9-4df6-a4a1-e4661c3bfad73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76168-013-077616800130736 in 1 BOTTLEHistorical
76168-013-12761680013121 in 1 CARTONHistorical