Indications and uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
whole foods-Diphenhydramine HCl Capsules, 50 mg dye free
- Manufacturer
- Whole Foods Market, INC. | Bionpharma Inc. | SOFTGEL HEALTHCARE PRIVATE LIMITED
- Effective date
- 2025-12-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:18:43
Label at a glance#
ProductNighttime Sleep-Aid
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure16 sections
Dosage and administration
■ Adults and children 12 years of age and over: One softgel (50 mg) at bedtime if needed, or as directed by a doctor. ■ swallow whole; do not crush, chew, or dissolve
Storage and handling
■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F). ■ protect from light
Contacts and useful links#
Websitewww.wholefoodsmarket.com
www.wholefoodsmarket.com
www.wholefoodsmarket.comLabel contents#
Full prescribing information#
Active ingredient (in each capsule)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
■ for relief of occasional sleeplessness ■ reduces time to fall asleep if you have difficulty falling asleep
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 ■ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
sleeplessness persists continuosly for more than 2 weeks, consult your doctor. Insomnia may be a symptom of 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.
Directions
■
Adults and children 12 years of age and over:One softgel (50 mg) at bedtime if needed, or as directed by a doctor.
■ swallow whole; do not crush, chew, or dissolve
Other information
■ store at 20°C to 25°C (68°F to 77°F) ■ avoid high humidity and excessive heat above 40°C (104°F).
■ protect from light
Inactive ingredients
gelatin, glycerin, polyethylene glycol 400, polyethylene glycol 600, propylene glycol, purified water, sorbitol sorbitan solution
Questions or comments?
call toll-free 1-888-235-2466 (Mon - Fri 9AM - 5PM EST)
SPL UNCLASSIFIED SECTION
DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP IS BROKEN OR MISSING.
READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION
DISTRIBUTED BY: WHOLE FOODS MARKET I 550 BOWIE STREET, AUSTIN, TX 78703
©2020 WHOLE FOODS MARKET IP, INC. I www.wholefoodsmarket.com
PRODUCT OF INDIAI**THIS PRODUCT IS NOT MANUFACTURED OR DISIRIBUTED BY THE OWNERS OF UNISOM® SLEEPGELS®
L0000950 R0125
Mfg. Lic. No.: TN00002123
Lot No.:
Exp. Date:
32s count
NDC 42681-0051-1
365
WHOLE FOODS
MARKET
Nighttime
Sleep-Aid
Diphenhydramine HCl
Capsules USP, 50 mg
Maximum Strength
Fall asleep fast & Sleep Soundly
safe, non habit-forming
**Compare to the Active Ingredient inUnisom®SleepGels®
One softgel per dose
32
SOFTGELS*
*Liquid-filled capsules
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42681-0051-1 | Nighttime Sleep-Aid | 32 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 32 | 3 | |
| 42681-0051-1 | Nighttime Sleep-Aid | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | 3 |
Products#
Every source-derived product name is available through these pages.
- Nighttime Sleep-Aid
- Diphenhydramine HCl
- POLYETHYLENE GLYCOL 600
- SORBITAN
- GELATIN
- POLYETHYLENE GLYCOL 400
- WATER
- GLYCERIN
- PROPYLENE GLYCOL
- SORBITOL
- DIPHENHYDRAMINE HYDROCHLORIDE
- DIPHENHYDRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 42681-0051 | 42681-0051-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 600 | NL4J9F21N9 | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| GELATIN | 2G86QN327L | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| DIPHENHYDRAMINE HYDROCHLORIDE | TC2D6JAD40 | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 35acf7d9-e567-996d-e063-6394a90a1cf6 | 2025-12-01 | Warnings | 42681-0051-1 42681-0051 42681005101 44e96829-a666-934f-e063-6394a90acd36 35acf7d9-e567-996d-e063-6394a90a1cf6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.