Diphenhydramine

Product NDC
21695-304
11-digit product format
216950304
Labeler code
21695
Product ID
21695-304_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-01-01
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-304-15Diphenhydramine15 in 1 BOTTLECAPSULE151
21695-304-20Diphenhydramine20 in 1 BOTTLECAPSULE201
21695-304-24Diphenhydramine24 in 1 BOTTLECAPSULE241
21695-304-30Diphenhydramine30 in 1 BOTTLECAPSULE301
21695-304-90Diphenhydramine90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-304-15EA - Each21695-30483718c91-9a60-4d40-9f7f-bac69efb073612012-07-24
21695-304-20EA - Each21695-30402d784f9-c794-4017-a59e-81b5538445fa12012-07-24
21695-304-24EA - Each21695-30407122334-5903-4d02-a535-697b4da6a54812012-07-24
21695-304-30EA - Each21695-304a5937aa7-a403-4932-af97-1390dde3e0be12012-07-24
21695-304-90EA - Each21695-30403d58220-08a6-46b7-af4a-7d19a13a53b312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-304DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 package rows20110223_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc46e1443-dffe-47a9-bc9a-acbe3a8b0b411
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc46e1443-dffe-47a9-bc9a-acbe3a8b0b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-304-152169503041515 in 1 BOTTLEHistorical
21695-304-202169503042020 in 1 BOTTLEHistorical
21695-304-242169503042424 in 1 BOTTLEHistorical
21695-304-302169503043030 in 1 BOTTLEHistorical
21695-304-902169503049090 in 1 BOTTLEHistorical