FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
66424-021
11-digit product format
664240021
Labeler code
66424
Product ID
66424-021_2ba30474-41ba-6c1a-e063-6394a90a9631
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
SDA Laboratories, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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
Diphenhydramine HCL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1020477

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
66424-021-012023-06-13C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-102023-06-13C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-012020-01-31C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-102020-01-31C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-021-01Diphenhydramine HCL100 in 1 BOTTLE, PLASTICCAPSULE1003
66424-021-10Diphenhydramine HCL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-021-01EA - Each66424-0219776653f-7c63-4b8b-a643-b1ff6450406412012-07-24
66424-021-10EA - Each66424-021fa4dd348-3929-4217-a7fb-c7f312f780c812012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-021DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250115_437e6a13-a4ff-4f98-8973-042f224ee85e.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
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydramine HCl 50 MG Oral CapsuleSYc1873a4c-661f-4896-bcc0-f6d3a655de945
1020477diphenhydramine HCl 50 MG Oral CapsuleSY6e91b9c3-57e8-488b-ac70-d863cdf9d6e85
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY489645ad-d7da-5f52-e054-00144ff8d46c4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN437e6a13-a4ff-4f98-8973-042f224ee85e3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD437e6a13-a4ff-4f98-8973-042f224ee85e3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY437e6a13-a4ff-4f98-8973-042f224ee85e3
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
66424-021-0166424002101100 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-01) 100 capsule2010-01-27NoNoCurrent
66424-021-10664240021101000 CAPSULE in 1 BOTTLE, PLASTIC (66424-021-10) 1000 capsule2010-01-27NoNoCurrent