FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
71335-0435
Requested package NDC
71335-0435-5
11-digit product format
713350435
Labeler code
71335
Product ID
71335-0435_b5a7fa2e-d908-49b7-8441-72a692a02614
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-01-02
Marketing end
0000-00-00
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
2023-12-31
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 packagepackage71335-043571335-0435-5DDiscontinued by firm2026-10-12

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-043571335-0435-5DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0435-0EA - Each71335-043557d36003-e431-4e06-a09a-e1cf8e082b4c12018-03-08
71335-0435-1EA - Each71335-0435fbf130ae-4b14-4b48-b538-96ea9de817a212018-03-08
71335-0435-2EA - Each71335-043532bcefcf-b855-4aad-b5a7-a0c5db5c0eea12018-03-08
71335-0435-3EA - Each71335-0435f954522d-42b5-4793-968f-31492090b2cb12018-03-08
71335-0435-4EA - Each71335-0435b8fb5b11-6ad6-460e-9cf3-89bbdcb36a0712018-03-08
71335-0435-5EA - Each71335-0435f5170598-c1bf-4ec8-b427-d826e1bcc05a12018-03-08
71335-0435-6EA - Each71335-0435d024b8f4-18ee-47cf-bfd3-ba34b13da54d12018-03-08
71335-0435-7EA - Each71335-043509a98da9-ee4c-412d-a0e1-168fd1b5cdd612018-03-08
71335-0435-8EA - Each71335-0435b1b04fdb-a818-4a87-8bd1-8db93cc392d912018-03-08
71335-0435-9EA - Each71335-0435d043d9f5-36c4-4b94-a360-b464233cb16912018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0435DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]9Legacy NDC20250221_b5a7fa2e-d908-49b7-8441-72a692a02614.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0435-57133504350515 CAPSULE in 1 BOTTLE (71335-0435-5) 15 capsule2019-01-280000-00-00NoNoCurrent