FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
71399-1028
11-digit product format
713991028
Labeler code
71399
Product ID
71399-1028_35428d00-fa38-6055-e063-6394a90a7a78
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Akron Pharma Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-06
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, 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
71399-1028-1Diphenhydramine HCl100 in 1 BOTTLECAPSULE1003
71399-1028-2Diphenhydramine HCl1000 in 1 BOTTLECAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-1028-1EA - Each71399-10282876bc81-25fa-4859-b8a3-5b65bd1611dc12025-02-10
71399-1028-2EA - Each71399-102847affbac-dbed-45be-b86d-698e56a8595b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-1028DIPHENHYDRAMINE HCL CAPSULE [AKRON PHARMA INC.]3Current NDC, 2 package rows20250519_79a6b8c7-0e81-4a46-a854-31f449042709.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN79a6b8c7-0e81-4a46-a854-31f4490427093
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN79a6b8c7-0e81-4a46-a854-31f4490427093
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD79a6b8c7-0e81-4a46-a854-31f4490427093
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD79a6b8c7-0e81-4a46-a854-31f4490427093
1020477diphenhydramine HCl 50 MG Oral CapsuleSY79a6b8c7-0e81-4a46-a854-31f4490427093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71399-1028-171399102801100 CAPSULE in 1 BOTTLE (71399-1028-1) 100 capsule2024-12-06NoNoHistorical
71399-1028-2713991028021000 CAPSULE in 1 BOTTLE (71399-1028-2) 1000 capsule2024-12-06NoNoHistorical