Diphenhydramine HCL

Product NDC
66267-081
11-digit product format
662670081
Labeler code
66267
Product ID
66267-081_1f98d6d5-cf09-a2bf-e063-6294a90a370b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, 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
66267-081-302024-08-13C16284748780-1f386c649-b6f4-0266-e053-dadaa90a7c1aDrug Facts
66267-081-302023-01-30C16284748780-1f386c649-b6f4-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-081-30Diphenhydramine HCL30 in 1 BOTTLE, PLASTICCAPSULE304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-081-30EA - Each66267-081d293da99-29b0-4071-a092-33e7612fbd3012016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-081DIPHENHYDRAMINE HCL CAPSULE [NUCARE PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20240815_3dbdf020-ca17-1197-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3dbdf020-ca17-1197-e054-00144ff8d46c4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3dbdf020-ca17-1197-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-081-306626700813030 CAPSULE in 1 BOTTLE, PLASTIC (66267-081-30) 30 capsule2016-09-300000-00-00NoNoCurrent