TheraRadar
Data updated: May 26, 2026

ALEVE PM (diphenhydramine hydrochloride)

Immunology Approved 2014-01-17
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
12
Years on Market

Details

Status
Over-the-counter
First Approved
2014-01-17
Routes
ORAL
Dosage Forms
TABLET

Companies

Bayer
Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE , NAPROXEN SODIUM

ALEVE PM Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
15 FDA actions from 2014 to 2022
Feb 2022 SUPPL
Label · Labeling
FDA Letter Label
Oct 2020 SUPPL
Label · Labeling
FDA Letter Label
Apr 2020 SUPPL
Label · Labeling
FDA Letter Label

What ALEVE PM Treats

1 FDA approvals

Originally approved for its first indication in 2014 .

  • Other (1)
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Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04963296 ALLEGORY CA42750 2020-005760-57, 2023-504774-38-00 Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With Systemic Lupus Erythematosus
NCT05627557 INShore WA43380 2022-000369-42, 2023-505140-19-00 Ph 3 active not recruiting A Study to Evaluate the Efficacy and Safety of Obinutuzumab Versus MMF in Participants With Childhood Onset Idiopathic Nephrotic Syndrome
NCT02578186 results posted 2013063 Ph 4 completed Evaluation of Diphenhydramine Hydrochloride Effects in Subjects With Occasional Sleeplessness
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ALEVE PM FDA Label Details

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Data Sources

FDA Approval: NDA205352 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.