FDA.reportPublic FDA data

Allergy Medicine

Product NDC
63981-329
11-digit product format
639810329
Labeler code
63981
Product ID
63981-329_3bde2a18-7cfe-461e-b8e4-8a4c3efb8437
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
COSTCO WHOLESALE CORPORATION
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1990-03-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Medicine
Listing expiration
2027-12-31

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
63981-329-78Allergy Medicine600 in 1 BOTTLE, PLASTICTABLET, FILM COATED60020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-329-78EA - Each63981-32998a66b0e-bb3c-4397-a127-3a41b7bd043412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET [COSTCO WHOLESALE CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-329ALLERGY MEDICINE (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [COSTCO WHOLESALE CORPORATION]19Current NDC, Legacy NDC, 1 package rows20250418_d9f03e11-d11f-43ee-8ed0-9e07d1058f66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSNd9f03e11-d11f-43ee-8ed0-9e07d1058f6621
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCDd9f03e11-d11f-43ee-8ed0-9e07d1058f6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63981-329-7863981032978600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-329-78) 1990-03-020000-00-00NoNoCurrent