FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Product NDC
70692-784
Requested package NDC
70692-784-02
11-digit product format
706920784
Labeler code
70692
Product ID
70692-784_dc79366e-6431-4458-e053-2a95a90a7e14
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strive Pharmaceuticals Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-08-20
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 packagepackage70692-78470692-784-02IInactivated by FDA2026-10-20

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 · 2 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
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70692-78470692-784-02IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70692-78470692-784-02IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-784-022022-04-12C16284748780-1d6a99b39-7f7d-a426-e053-dadaa90af4c2Sleep-Aid Diphenhydramine HCl 25mg (Purple Softgel)
70692-784-022022-01-28C16284748780-1d6a99b39-7f7d-a426-e053-dadaa90af4c2Sleep-Aid Diphenhydramine HCl 25mg (Purple Softgel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-784-02Diphenhydramine Hydrochloride20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-784DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]6Legacy NDC, 1 package rows20240125_96a07573-f3bd-528c-e053-2995a90a81c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN96a07573-f3bd-528c-e053-2995a90a81c56
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD96a07573-f3bd-528c-e053-2995a90a81c56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70692-784-027069207840220 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (70692-784-02) 2018-08-200000-00-00NoNoCurrent