FDA.reportPublic FDA data

Diphenhydramine HCl

Product NDC
71399-8026
Requested package NDC
71399-8026-2
11-digit product format
713998026
Labeler code
71399
Product ID
71399-8026_c29f906f-b348-05fd-e053-2995a90ab31b
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Akron Pharma Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-18
Marketing end
0000-00-00
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71399-802671399-8026-2IInactivated by FDA2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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, Related label table
NDCEffectiveRelated label
71399-8026-12025-01-30Akron Pharma, Inc.
71399-8026-22025-01-30Akron Pharma, Inc.
71399-8026-12023-02-28Akron Pharma, Inc.
71399-8026-22023-02-28Akron Pharma, Inc.
71399-8026-12023-01-30Akron Pharma, Inc.
71399-8026-22023-01-30Akron Pharma, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8026-1Diphenhydramine HCl100 in 1 BOTTLECAPSULE1005
71399-8026-2Diphenhydramine HCl1000 in 1 BOTTLECAPSULE10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8026-2EA - Each71399-8026d16da9fa-45f5-4c6e-aa6c-fbdf54ab10c912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8026DIPHENHYDRAMINE HCL CAPSULE [AKRON PHARMA INC.]5Legacy NDC, 2 package rows20230302_aa8e72b9-ae59-4563-b3c7-9d48d0cc2c52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSNaa8e72b9-ae59-4563-b3c7-9d48d0cc2c525
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCDaa8e72b9-ae59-4563-b3c7-9d48d0cc2c525
1020477diphenhydramine HCl 50 MG Oral CapsuleSYaa8e72b9-ae59-4563-b3c7-9d48d0cc2c525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-8026-2713998026021000 CAPSULE in 1 BOTTLE (71399-8026-2) 1000 capsule2021-05-180000-00-00NoNoCurrent