I-Sleep
- Product NDC
- 55714-2568
- 11-digit product format
- 557142568
- Labeler code
- 55714
- Product ID
- 55714-2568_c6a08953-15c4-797d-e053-2a95a90a7a0c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Absinthium, Anacardium orientale, Arg. nit., Arsenicum alb., Belladonna, Bryonia, Calc. carb., Camphora, Chamomilla, Cimicifuga, Cinchona, Coffea cruda, Cypripedium, Gelsemium, Humulus, Hyoscyamus, Ignatia, Kali brom., Nux vom., Passiflora, Pulsatilla, Scutellaria lateriflora, Sepia, Thuja occ., Valeriana
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Newton Laboratories, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2021-02-01
- Substance
- ANEMONE PULSATILLA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CAMPHOR (NATURAL); CINCHONA OFFICINALIS BARK; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; GELSEMIUM SEMPERVIRENS ROOT; HOPS; HYOSCYAMUS NIGER; MATRICARIA CHAMOMILLA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PASSIFLORA INCARNATA FLOWERING TOP; POTASSIUM BROMIDE; SCUTELLARIA LATERIFLORA WHOLE; SEMECARPUS ANACARDIUM JUICE; SEPIA OFFICINALIS JUICE; SILVER NITRATE; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VALERIAN; WORMWOOD
- Active strength
- 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], 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], Increased Histamine Release [PE], Increased IgG Production [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], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage 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
- I-Sleep
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ANEMONE PULSATILLA | 15 [hp_X]/mL |
| ARABICA COFFEE BEAN | 15 [hp_X]/mL |
| ARSENIC TRIOXIDE | 15 [hp_X]/mL |
| ATROPA BELLADONNA | 15 [hp_X]/mL |
| BLACK COHOSH | 15 [hp_X]/mL |
| BRYONIA ALBA ROOT | 15 [hp_X]/mL |
| CAMPHOR (NATURAL) | 15 [hp_X]/mL |
| CINCHONA OFFICINALIS BARK | 15 [hp_X]/mL |
| CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT | 15 [hp_X]/mL |
| GELSEMIUM SEMPERVIRENS ROOT | 15 [hp_X]/mL |
| HOPS | 15 [hp_X]/mL |
| HYOSCYAMUS NIGER | 15 [hp_X]/mL |
| MATRICARIA CHAMOMILLA | 15 [hp_X]/mL |
| OYSTER SHELL CALCIUM CARBONATE, CRUDE | 15 [hp_X]/mL |
| PASSIFLORA INCARNATA FLOWERING TOP | 15 [hp_X]/mL |
| POTASSIUM BROMIDE | 15 [hp_X]/mL |
| SCUTELLARIA LATERIFLORA WHOLE | 15 [hp_X]/mL |
| SEMECARPUS ANACARDIUM JUICE | 15 [hp_X]/mL |
| SEPIA OFFICINALIS JUICE | 15 [hp_X]/mL |
| SILVER NITRATE | 15 [hp_X]/mL |
| STRYCHNOS IGNATII SEED | 15 [hp_X]/mL |
| STRYCHNOS NUX-VOMICA SEED | 15 [hp_X]/mL |
| THUJA OCCIDENTALIS LEAFY TWIG | 15 [hp_X]/mL |
| VALERIAN | 6 [hp_X]/mL |
| WORMWOOD | 15 [hp_X]/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | I76KB35JEV, 3SW678MX72, S7V92P67HO, WQZ3G9PF0H, K73E24S6X9, T7J046YI2B, N20HL7Q941, S003A158SB, 21Y9GZ1LZA, 639KR60Q1Q, 01G73H6H83, 4WRK2153H3, G0R4UBI2ZZ, 2E32821G6I, CLF5YFS11O, OSD78555ZM, 7BP4DH5PDC, Y0F0BU8RDU, QDL83WN8C2, 95IT3W8JZE |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55714-2568-1 | I-Sleep | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55714-2568 | I-SLEEP (ABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANA) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20210709_c6a08752-db62-2187-e053-2a95a90af138.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55714-2568-1 | 55714256801 | 30 mL in 1 BOTTLE, GLASS (55714-2568-1) | 30 ml | 2021-02-01 | 0000-00-00 | No | No | Current |