Websitewww.ohmpharma.com
www.ohmpharma.com
www.ohmpharma.comOHM Sleep Well
- Manufacturer
- OHM PHARMA INC.
- Effective date
- 2021-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 02:15:26
Label at a glance#
ProductOHM Sleep Well
Active ingredientAVENA SATIVA FLOWERING TOP, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, STRYCHNOS NUX-VOMICA SEED, PASSIFLORA INCARNATA FLOWERING TOP, DATURA STRAMONIUM, VALERIAN
Label structure8 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (HPUS*): Equal amounts of: Avena Sativa 4X, Coffea Cruda 30C, Ignatia Amara 12C, Nux Vomica 30C, Passiflora Incarnata 4X, Stramonium 30C, Valeriana Officinalis 4X.
*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.
INDICATIONS & USAGE SECTION
USES: Temporarily relieves sleeplessness and simple insomnia due to restless mind and nightmares.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
WARNINGS SECTION
WARNINGS: IF PREGNANT OR BREAST-FEEDING, ask a health professional before use. If sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- KEEP OUT OF REACH OF CHILDREN.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Shake 10 times before use. Adults & children above 12 years: spray 3 times under the tongue 2 times before bedtime and during night as needed or as directed by a health care professional. Children under 12: use half the adult dose.
OTHER SAFETY INFORMATION
Do not use if cap seal is broken.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: Ethanol Alcohol 15% (Non-GMO, Kosher Certified, Corn, Gluten, Allergen Free), Purified Water, Vegetable Glycerin 15%
OTC - QUESTIONS SECTION
Mfg. By: OHM PHARMA, INC. Mineral Wells, TX 76067
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
HOMEOPATHIC MEDICINE
NDC: 66096-727-05
SLEEP Well
Natural - Safe - Effective
No Side Effects
2 fl oz (59mL) / 15% Alcohol
PRODUCT OF USA
OTC - PURPOSE SECTION
Insomnia
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66096-727-05 | OHM Sleep Well | 59 mL in 1 BOTTLE, GLASS | LIQUID | 59 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66096-727 | OHM SLEEP WELL (AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS.) LIQUID [OHM PHARMA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20211230_9cac0195-8dca-4c53-891c-d834f7479e30.zip |
Products#
Every source-derived product name is available through these pages.
- OHM Sleep Well
- Avena Sativa, Coffea Cruda, Ignatia Amara, Nux Vomica, Passiflora, Incarnata, Stramonium, Valeriana Officinalis.
- ALCOHOL
- WATER
- GLYCERIN
- AVENA SATIVA FLOWERING TOP
- ARABICA COFFEE BEAN
- STRYCHNOS IGNATII SEED
- STRYCHNOS NUX-VOMICA SEED
- PASSIFLORA INCARNATA FLOWERING TOP
- DATURA STRAMONIUM
- VALERIAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66096-727 | 66096-727-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| AVENA SATIVA FLOWERING TOP | MA9CQJ3F7F | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| STRYCHNOS IGNATII SEED | 1NM3M2487K | ACTIB |
| STRYCHNOS NUX-VOMICA SEED | 269XH13919 | ACTIB |
| PASSIFLORA INCARNATA FLOWERING TOP | CLF5YFS11O | ACTIB |
| DATURA STRAMONIUM | G6W4F0V8Z3 | ACTIB |
| VALERIAN | JWF5YAW3QW | 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 |
|---|---|---|---|---|---|---|
| OHM Sleep Well | AVENA SATIVA, COFFEA CRUDA, IGNATIA AMARA, NUX VOMICA, PASSIFLORA, INCARNATA, STRAMONIUM, VALERIANA OFFICINALIS. | OHM PHARMA INC. | 9cac0195-8dca-4c53-891c-d834f7479e30 | 2021-12-29 | Warnings | 66096-727-05 66096-727 66096072705 d44bb081-9f15-afc7-e053-2995a90a7245 9cac0195-8dca-4c53-891c-d834f7479e30 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.