SleepEase
- Product NDC
- 61096-2001
- 11-digit product format
- 610962001
- Labeler code
- 61096
- Product ID
- 61096-2001_cc630075-d315-46fe-a50d-3fb7f0215eb4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Aquilegia, Avena, Chamomilla, Coffea cruda, Cypripedium, Humulus, Kali phos, Passiflora, Valeriana, Zinc met
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Eight & Company L.L.C
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2019-04-24
- Substance
- AQUILEGIA VULGARIS; ARABICA COFFEE BEAN; AVENA SATIVA FLOWERING TOP; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIBASIC POTASSIUM PHOSPHATE; HOPS; MATRICARIA CHAMOMILLA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ZINC
- Active strength
- 4; 200; 4; 4; 12; 4; 4; 4; 4; 12 [hp_X]/41mL; [hp_C]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL; [hp_X]/41mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SleepEase
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AQUILEGIA VULGARIS | 4 [hp_X]/41mL |
| ARABICA COFFEE BEAN | 200 [hp_C]/41mL |
| AVENA SATIVA FLOWERING TOP | 4 [hp_X]/41mL |
| CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT | 4 [hp_X]/41mL |
| DIBASIC POTASSIUM PHOSPHATE | 12 [hp_X]/41mL |
| HOPS | 4 [hp_X]/41mL |
| MATRICARIA CHAMOMILLA WHOLE | 4 [hp_X]/41mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 4 [hp_X]/41mL |
| VALERIAN | 4 [hp_X]/41mL |
| ZINC | 12 [hp_X]/41mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8POZ61U1G2, 3SW678MX72, MA9CQJ3F7F, 21Y9GZ1LZA, CI71S98N1Z, 01G73H6H83, G0R4UBI2ZZ, CLF5YFS11O, JWF5YAW3QW, J41CSQ7QDS |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61096-2001-1 | SleepEase | 1 in 1 CARTON | LIQUID | 1 | | 6 |
| 61096-2001-1 | SleepEase | 41 mL in 1 BOTTLE, SPRAY | LIQUID | 41 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61096-2001 | SLEEPEASE (AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET) LIQUID [EIGHT & COMPANY L.L.C] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250519_9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61096-2001-1 | 61096200101 | 1 BOTTLE, SPRAY in 1 CARTON (61096-2001-1) / 41 mL in 1 BOTTLE, SPRAY | 2019-04-24 | 0000-00-00 | No | No | Current |