Active ingredient
Diphenhydramine
743 finished FDA listings contain Diphenhydramine as their only active ingredient; 381 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- DIPHENHYDRAMINE, DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage forms
- Bar, Chewable, Capsule, Capsule, Gelatin Coated, Capsule, Liquid Filled, Chewable Gel, Gel, Injection, Injection, Solution, Liquid, Solution, Spray, Syrup, Tablet, Tablet, Chewable, Tablet, Coated, Tablet, Film Coated
- Routes
- Intramuscular, Intravenous, Oral, Topical
- Manufacturers / labelers
- 266
- Strengths listed
- .4 g/20g · .51 g/25.5g · 1.14 g/57g · 12.5 mg/1 · 12.5 mg/10ml · 12.5 mg/15ml · 12.5 mg/5ml · 2 g/100g · 2 g/100ml · 2 mg/100ml · 20 mg/g · 20 mg/ml · 20.3 g/l · 25 mg/1 · 25 mg/10ml · 25 mg/25mg · 25 mg/5ml · 50 mg/1 · 50 mg/20ml · 50 mg/21 · 50 mg/30ml · 50 mg/3ml · 50 mg/g · 50 mg/ml
- Brand names in FDA listings (first 80 of 255, A–Z)
- A Health Itch Relief Gel, Adult Allergy Relief, Adult Allergy Relief Dye Free, Adwe Dye-Free Childrens Allergy, After Bite Outdoor, After Bite Xtra, Allergies My Child Needs Help With, Allergy, Allergy 36ct, Caseys 4good, Allergy Antihistamine, Allergy Childrens, Allergy Childrens Allergy, Allergy Medicine, Allergy Relief, Allergy Relief 25 Mg, Allergy Relief Caplet, Allergy Relief Childrens, Allergy Relief Complete, Allergy Relief Diphenhydramine Hcl, Allergy Relief Diphenhydramine Hcl 25mg Softgel, Allergy Relief Diphenhydramine Hcl 50 Mg, Allergy Relief Dye Free, Allergy Relief Dye-Free, Allergy Relief Dye-Free Softgel, Allergy Relief Extra Strength, Allergy Relief Mini Softgels, Allergy Relief, 24-7 Life By 7-Eleven, Allergy Relief, 24-7 Lift By 7-Eleven, Allergy, Circle K, Allergy, Lil Drug Store, Antihistamine, Axiv - Vrozzz, Axiv Allergy, Axiv Allergy Relief, Bactimicina Childrens Allergy, Banophen, Basic Care Allergy Relief, Basic Care Childrens Allergy Relief, Basic Care Nighttime Sleep Aid, Benadryl, Benadryl Allergy, Benadryl Allergy Extra Strength, Benadryl Allergy Extra Strength Liqui-Gels, Benadryl Allergy Liqui-Gels, Benadryl Allergy Ultratab, Benadryl Extra Strength Itch Stopping, Benadryl Ultratabs, Berkley And Jensen Allergy Relief, Berkley And Jensen Sleep Aid, Best Choice Childrens Allergy Relief Bubblegum Flavor, Best Choice Itch Stopping, Betr Sleep Aid, Cabinet Allergy Relief Refill Diphenhydramine Hci, Calmco Allergy Relief, Calmco Sleep Aid, Calmco Sleep Aid Gummy Bite, Careall Allergy Relief, Careall Diphenhydramine, Careone Allergy Relief, Careone Childrens Allergy Relief, Careone Nighttime Sleep Aid, Children Allergy Relief Bubblegum Flavor, Children Allergy Relief Dye Free Cherry, Childrens Allergy, Childrens Allergy Dye Free Wal Dryl, Childrens Allergy Relief, Childrens Allergy Relief Dye Free, Childrens Allergy Relief Dye-Free, Childrens Benadryl Allergy, Childrens Benadryl Chewables, Childrens Benadryl Dye-Free Allergy, Childrens Chewable Allergy Relief, Childrens Dye Free Allergy, Childrens Dye Free Allergy Relief, Circle K Allergy Antihistamine, Complete Allergy Medicine, Cvs Diphenhydramine Hydrochloride, Cvs Dye-Free Childrens Allergy, Cvs Health Childrens Allergy Relief, Cvs Health Nighttime Sleep Aid
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3498
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 080817 | WEST-WARD PHARMS INT | 1972-11-27 | 11 |
| ANDA 087513 | PHARM ASSOC | 1982-02-10 | 4 |
| ANDA 040466 | APP PHARMS | 2002-05-28 | 6 |
| ANDA 091526 | FRESENIUS KABI USA | 2013-03-26 | 2 |
| ANDA 205723 | MICRO LABS | 2018-08-22 | 6 |
| ANDA 218448 | GLAND | 2024-03-20 | 2 |
| ANDA 205336 | AVET LIFESCIENCES | 2025-06-24 | 4 |
| ANDA 219845 | MICRO LABS | 2025-08-22 | 1 |
| ANDA 205337 | AVET LIFESCIENCES | 2025-11-14 | 1 |
| ANDA 219470 | ANNORA PHARMA | 2026-06-17 | 2 |
Official labeling on DailyMed
- NIGHTTIME SLEEP AID BERRY FLAVOR (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [RARITAN PHARMACEUTICALS INC] · version 8 · 2026-09-10
- VICKS ZZZQUIL NIGHTTIME SLEEP-AID DIPHENHYDRAMINE HCL FREE OF (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY] · version 8 · 2026-09-10
- NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [KROGER] · version 2 · 2026-09-07
- DRX CHOICE CHILDRENS ALLERGY CHEWS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [RARITAN PHARMACEUTICALS INC] · version 5 · 2026-09-07
- SLEEP AID (DIPHENHYDRAMINE HCL) CAPSULE [TARGET CORPORATION] · version 6 · 2026-09-03
- KROGER DYE FREE CHILDRENS ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) SYRUP [KROGER COMPANY] · version 4 · 2026-09-03
- KROGER NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [KROGER COMPANY] · version 4 · 2026-09-03
- TECNU DIPHENHYDRAMINE HCL PAIN RELIEVING ANTI ITCH GEL 2% (ANTI ITCH GEL) GEL [WALGREENS] · version 3 · 2026-09-03
- ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC] · version 2 · 2026-09-02
- MAX ALLERGY KIDS (DIPHENHYDRAMINE HCL) SOLUTION [AKRON PHARMA INC.] · version 6 · 2026-09-02
- HYVEE MAXIMUM STRENGTH NIGHTTIME SLEEP-AID SOFTGEL (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [HYVEE INC] · version 2 · 2026-09-02
- DIPHENHYDRAMINE HCL SOLUTION [MAJOR PHARMACEUTICALS] · version 15 · 2026-08-31
Showing the 12 most recent of 702 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.