TheraRadar
Data updated: May 26, 2026

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE (diphenhydramine hydrochloride)

Immunology Approved 2018-10-23
Jump to: Indications Approvals Trials Competitors Safety Patents
5
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Over-the-counter
First Approved
2018-10-23
Routes
ORAL
Dosage Forms
TABLET

Companies

PERRIGO R AND D AMNEAL PHARMS CO GRANULES P AND L COREPHARMA
Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE , NAPROXEN SODIUM

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
7 FDA actions from 2018 to 2023
Oct 2023 SUPPL
Label · Labeling
Sep 2020 ORIGINAL
Update
Aug 2019 ORIGINAL
Update
FDA Letter

What NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE Treats

5 FDA approvals

Originally approved for its first indication in 2018 . Covers 5 distinct patient populations.

  • Other (5)
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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

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Ongoing clinical trials by development phase

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Key Completed Trials

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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.

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE FDA Label Details

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Data Sources

FDA Approval: ANDA208499 → Trials: ClinicalTrials.gov →

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