FDA.reportPublic FDA data

Diphenhydramine HCL

Product NDC
66424-020
11-digit product format
664240020
Labeler code
66424
Product ID
66424-020_2ba32ed3-96ca-2dd9-e063-6294a90a8d81
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
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40
Rxcui1049909

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
66424-020-012023-06-13C16284748780-19d75b9d1-0ce7-f424-e053-dadaa90a57ceDrug Facts
66424-020-102023-06-13C16284748780-19d75b9d1-0ce7-f424-e053-dadaa90a57ceDrug Facts
66424-020-012020-01-31C16284748780-19d75b9d1-0ce7-f424-e053-dadaa90a57ceDrug Facts
66424-020-102020-01-31C16284748780-19d75b9d1-0ce7-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-020-01Diphenhydramine HCL100 in 1 BOTTLE, PLASTICCAPSULE1003
66424-020-10Diphenhydramine HCL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-020-01EA - Each66424-02062be7459-d627-4d56-af74-b18dfb1581dc12012-07-24
66424-020-10EA - Each66424-020cc145bd4-6e21-4bfe-a7b2-2ffe0528742b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [BLENHEIM PHARMACAL, INC.]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIPHENHYDRAMINE 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 [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIPHENHYDRAMINE HCL CAPSULE [PHYSICIANS TOTAL CARE, 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
66424-020DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250115_6a520986-1004-4ee6-9a47-1dfd90bb1b2c.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
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5767f546-a751-4583-a8b7-971175c27ef08
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNa5809774-ed52-4f54-b48e-888631e0223d8
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDa5809774-ed52-4f54-b48e-888631e0223d8
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5767f546-a751-4583-a8b7-971175c27ef08
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN59aeb692-2f79-45aa-8e6a-dab77cd3b2f95
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3dbdf67f-766b-12ee-e054-00144ff8d46c5
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD59aeb692-2f79-45aa-8e6a-dab77cd3b2f95
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3dbdf67f-766b-12ee-e054-00144ff8d46c5
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5411544e-3c2d-4e42-e054-00144ff8d46c4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5411544e-3c2d-4e42-e054-00144ff8d46c4
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN5943d975-77e4-4cbd-b2d9-d699052fe82a3
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN6a520986-1004-4ee6-9a47-1dfd90bb1b2c3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD5943d975-77e4-4cbd-b2d9-d699052fe82a3
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD6a520986-1004-4ee6-9a47-1dfd90bb1b2c3
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN7d6268c7-b2a9-1bbf-e053-2a91aa0a5d322
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN117fead9-699d-57ae-e054-00144ff88e882
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD7d6268c7-b2a9-1bbf-e053-2a91aa0a5d322
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD117fead9-699d-57ae-e054-00144ff88e882
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2b9b13b5-b530-4359-b094-1708c7a8e6d51
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN17df154b-af18-43ab-ae62-332b33454e4c1
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSNc46e1443-dffe-47a9-bc9a-acbe3a8b0b411
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2b9b13b5-b530-4359-b094-1708c7a8e6d51
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD17df154b-af18-43ab-ae62-332b33454e4c1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCDc46e1443-dffe-47a9-bc9a-acbe3a8b0b411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66424-020-0166424002001100 CAPSULE in 1 BOTTLE, PLASTIC (66424-020-01) 100 capsule2010-01-27NoNoCurrent
66424-020-10664240020101000 CAPSULE in 1 BOTTLE, PLASTIC (66424-020-10) 1000 capsule2010-01-27NoNoCurrent