FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
68788-9687
11-digit product format
687889687
Labeler code
68788
Product ID
68788-9687_c01dc08f-91c0-4361-98d3-56ad09bf951a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
341
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-27
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
Diphenhydramine HCL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477, 1049909

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
68788-9687-0Diphenhydramine HCL10 in 1 BOTTLE, PLASTICCAPSULE1012
68788-9687-1Diphenhydramine HCL15 in 1 BOTTLE, PLASTICCAPSULE1512
68788-9687-3Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE3012

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9687DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 3 package rows20250330_3ac0beba-303d-404e-bfec-0cf8c0e8624d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3ac0beba-303d-404e-bfec-0cf8c0e8624d12
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3ac0beba-303d-404e-bfec-0cf8c0e8624d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9687-06878896870010 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-0) 10 capsule2013-03-270000-00-00NoNoCurrent
68788-9687-16878896870115 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-1) 15 capsule2013-03-270000-00-00NoNoCurrent
68788-9687-36878896870330 CAPSULE in 1 BOTTLE, PLASTIC (68788-9687-3) 30 capsule2013-03-270000-00-00NoNoCurrent