FDA.reportPublic FDA data

Pharbedryl

Product NDC
16103-348
11-digit product format
161030348
Labeler code
16103
Product ID
16103-348_1c298805-036e-4cd1-87cc-1d2e413043b8
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-02-01
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
Pharbedryl
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
16103-348-032023-06-13C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-082023-06-13C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-112023-06-13C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-032023-01-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-082023-01-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-112023-01-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-032021-03-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-082021-03-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-112021-03-30C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-032020-01-31C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-082020-01-31C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts
16103-348-112020-01-31C16284748780-19d75b9d0-cc73-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-348-08Pharbedryl100 in 1 BOTTLE, PLASTICCAPSULE1005
16103-348-08Pharbedryl1 in 1 CARTONCAPSULE15
16103-348-11Pharbedryl1000 in 1 BOTTLE, PLASTICCAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-348-03EA - Each16103-3485de1d9de-7e1e-4271-80c4-090cadb9fcd812012-07-24
16103-348-08EA - Each16103-34890cd3e96-3e7f-40bb-a237-08d4664982ea12014-12-01
16103-348-11EA - Each16103-3483310a6e3-4317-40ac-a106-9f7606a265f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-348PHARBEDRYL (DIPHENHYDRAMINE HCL) CAPSULE [PHARBEST PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 3 package rows20250101_070e556b-e083-452f-8a7c-aca92470dd61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1ee41c86-6767-43ca-a5bb-fc685fa662cd13
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1ee41c86-6767-43ca-a5bb-fc685fa662cd13
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN070e556b-e083-452f-8a7c-aca92470dd615
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD070e556b-e083-452f-8a7c-aca92470dd615
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN3ef18965-bafb-cc19-e063-6394a90af17d2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD3ef18965-bafb-cc19-e063-6394a90af17d2
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN58ec2d97-168b-505a-e053-2991aa0a39781
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD58ec2d97-168b-505a-e053-2991aa0a39781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16103-348-03161030348031 BOTTLE, PLASTIC in 1 CARTON (16103-348-03) > 24 CAPSULE in 1 BOTTLE, PLASTIC2016-02-010000-00-00NoNoCurrent
16103-348-08161030348081 BOTTLE, PLASTIC in 1 CARTON (16103-348-08) / 100 CAPSULE in 1 BOTTLE, PLASTIC2016-02-010000-00-00NoNoCurrent
16103-348-11161030348111000 CAPSULE in 1 BOTTLE, PLASTIC (16103-348-11) 1000 capsule2016-02-010000-00-00NoNoCurrent