Checked
Sleep
diphenhydramine hcl · Sleep is an over-the-counter drug containing diphenhydramine hcl, made by Salado Sales, Inc..
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Oral
- Manufacturers
- 1
for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing04/23/2025Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem...Chattem Inc · CGMP Deviations; detection of Nitrosamine Drug Substance-Related...
- Class IIDrugOngoing03/19/2025Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per...Chattem Inc · CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity...
- Class IIIDrugOngoing01/22/2025Diphenhydramine HCl 25 mg, 100 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc....Akron Pharma, Inc. · 3 products · Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted...
- Class IDrug01/31/2024Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL)...Haleon US Holdings LLC · Microbial Contamination of Non-Sterile Products
- Class IIDrug05/31/2023diphenhydrAMINE 25 mg added to 0.9% sodium chloride 50 mL in 100 mL Partial Additive Bag, Rx only, Central...Central Admixture Pharmacy Services, Inc. · 2 products · Lack of Assurance of Sterility: after an FDA inspection called...
Active ingredients
(in each tablet) Diphenhydramine HCl 25 mg
Purpose
Nighttime sleep-aid
Uses
For relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
Directions
Do not take more than directed adults and children 12 years and over: take 2 tablets at bedtime if needed or as directed by a doctor children under 12 years: do not use
Warnings
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 glaucoma a breathing problem such as emphysema or chronic bronchitis 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 a serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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
Glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use
Taking sedatives or tranquilizers.
When using this product
Avoid alcoholic beverages.
Stop use and ask a doctor
Sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Pregnancy or breastfeeding
Ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away.
Other information
Each tablet contains: calcium 60 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN protect from moisture store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Inactive ingredients
Croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid
Questions?
1-800-426-9391
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Tablet | 25 mg | oral | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 11,077 reports that list diphenhydramine hcl, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Completed suicide796
- Death685
- Fatigue651
- Nausea628
- Pain566
- Dyspnea547
- Diarrhea533
- Headache507
- Drug ineffective499
- Infusion related reaction496
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- Salado Sales, Inc.Shown hereM010 · Label 11/24/2025 · NDC 57243-189Full label
Sleep: common questions
- What is Sleep used for?
- for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep
- Is Sleep a prescription drug?
- No. Sleep is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Sleep?
- Yes. Other FDA-listed products with the same active ingredients include Allergy Relief, nighttime sleep aid, Allergy Relief, Sleep Aid.
- Who makes Sleep?
- Salado Sales, Inc. lists Sleep with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/24/2025 · Label text is shown as published by the manufacturer. Not medical advice