Indications and uses
■ for relief of occasional sleeplessness
Diphenhydramine Hydrochloride
- Manufacturer
- PHARMACY VALUE ALLIANCE, LLC
- Effective date
- 2021-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:37:36
Label at a glance#
ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections
Dosage and administration
adults & children 12 years of age and over: 1 gelcap (50 mg) at bedtime if needed, or as directed by a doctor
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient
(in each gelcap)
Diphenhydramine HCl USP 50 mg
Purpose
Nighttime sleep-aid
Uses
■ for relief of occasional sleeplessness
Do Not Use
■ for children under 12 years of age
■ with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
■ a breathing problem such as emphysema, or chronic bronchitis
■ glaucoma
■ difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers
When using this product
■ avoid alcoholic beverages
Stop use and ask a doctor if
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
If pregnant or breast-feeding
ask a health professional before use.
Keep out of the reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
adults & children 12 years of age and over: 1 gelcap (50 mg) at bedtime if needed, or as directed by a doctor
Other information
■ store at 20°-25°C (68°-77°F). See USP Controlled Temperature.
■ avoid high humidity
Inactive ingredients
ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, dicalcium phosphate dihydrate, FD&C blue #1, FD&C yellow #6, gelatin, hydroxy propyl cellulose, hypromellose, isopropyl alcohol, lecithin, magnesium stearate, microcrystalline cellulose, n-butyl alcohol, polyethylene glycol, polyvinyl alcohol, propylene glycol, shellac, talc, titanium dioxide, xanthan gum.
Questions or comments?
call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST
Diphenhydramine HCl 50 mg RR Gelcaps
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DIPHENHYDRAMINE Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68016-795-48 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3b65-111a-e063-dadaa90a10e2 | Nighttime Sleep-Aid Diphenhydramine HCl USP, 50 mg NIGHTTIME SLEEP-AID Rapid Release |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68016-795-48 | Diphenhydramine Hydrochloride | 48 in 1 BOTTLE | TABLET | 48 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Diphenhydramine Hydrochloride
- MICROCRYSTALLINE CELLULOSE
- TITANIUM DIOXIDE
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE
- PROPYLENE GLYCOL
- TALC
- AMMONIA
- XANTHAN GUM
- ISOPROPYL ALCOHOL
- FERROSOFERRIC OXIDE
- FD&C BLUE NO. 1
- FD&C YELLOW NO. 6
- D&C RED NO. 33
- BUTYL ALCOHOL
- SHELLAC
- SILICON DIOXIDE
- GELATIN
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- MAGNESIUM STEARATE
- POLYVINYL ALCOHOL, UNSPECIFIED
- DIPHENHYDRAMINE
- CROSCARMELLOSE SODIUM
- LECITHIN, SOYBEAN
- POLYETHYLENE GLYCOL, UNSPECIFIED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68016-795 | 68016-795-48 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ba16c18c-dfef-b574-e053-2a95a90aba2a | 87af0f63-61ea-0d10-e053-2995a90a03c6 | 2021-01-29 | Warnings | ba16c18c-dfef-b574-e053-2a95a90aba2a 87af0f63-61ea-0d10-e053-2995a90a03c6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.