i-sleep

Generic: 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

Labeler: newton laboratories, inc.
NDC Directory HUMAN OTC DRUG UNAPPROVED HOMEOPATHIC Inactive Finished

Drug Facts

Product Profile

Brand Name i-sleep
Generic 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
Labeler newton laboratories, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

anemone pulsatilla 20 [hp_X]/mL, arabica coffee bean 20 [hp_X]/mL, arsenic trioxide 20 [hp_X]/mL, atropa belladonna 20 [hp_X]/mL, black cohosh 20 [hp_X]/mL, bryonia alba root 20 [hp_X]/mL, camphor (natural) 20 [hp_X]/mL, cinchona officinalis bark 20 [hp_X]/mL, cypripedium parviflorum var. pubescens root 20 [hp_X]/mL, gelsemium sempervirens root 20 [hp_X]/mL, hops 20 [hp_X]/mL, hyoscyamus niger 20 [hp_X]/mL, matricaria chamomilla 20 [hp_X]/mL, oyster shell calcium carbonate, crude 20 [hp_X]/mL, passiflora incarnata flowering top 20 [hp_X]/mL, potassium bromide 20 [hp_X]/mL, scutellaria lateriflora whole 20 [hp_X]/mL, semecarpus anacardium juice 20 [hp_X]/mL, sepia officinalis juice 20 [hp_X]/mL, silver nitrate 20 [hp_X]/mL, strychnos ignatii seed 20 [hp_X]/mL, strychnos nux-vomica seed 20 [hp_X]/mL, thuja occidentalis leafy twig 20 [hp_X]/mL, valerian 11 [hp_X]/mL, wormwood 20 [hp_X]/mL

Manufacturer
Newton Laboratories, Inc.

Identifiers & Regulatory

Product NDC 55714-4844
Product ID 55714-4844_3f17fee1-6d69-aec2-e063-6294a90a02ed
Product Type HUMAN OTC DRUG
Marketing Category UNAPPROVED HOMEOPATHIC
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

Pharmacologic Class

Established (EPC)
non-standardized food allergenic extract [epc] non-standardized plant allergenic extract [epc]
Chemical Structure
allergens [cs] dietary proteins [cs] plant proteins [cs] seed storage proteins [cs] food additives [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 557144844
Hyphenated Format 55714-4844

Supplemental Identifiers

UNII
I76KB35JEV 3SW678MX72 S7V92P67HO WQZ3G9PF0H K73E24S6X9 T7J046YI2B N20HL7Q941 S003A158SB 21Y9GZ1LZA 639KR60Q1Q 01G73H6H83 4WRK2153H3 G0R4UBI2ZZ 2E32821G6I CLF5YFS11O OSD78555ZM 7BP4DH5PDC Y0F0BU8RDU QDL83WN8C2 95IT3W8JZE 1NM3M2487K 269XH13919 1NT28V9397 JWF5YAW3QW F84709P2XV
NUI
N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0516536 M0008672 N0000185001

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name i-sleep (source: ndc)
Generic 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 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 [hp_X]/mL
  • 11 [hp_X]/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, GLASS (55714-4844-1)
source: ndc

Packages (1)

Ingredients (25)

anemone pulsatilla (20 [hp_X]/mL) arabica coffee bean (20 [hp_X]/mL) arsenic trioxide (20 [hp_X]/mL) atropa belladonna (20 [hp_X]/mL) black cohosh (20 [hp_X]/mL) bryonia alba root (20 [hp_X]/mL) camphor (natural) (20 [hp_X]/mL) cinchona officinalis bark (20 [hp_X]/mL) cypripedium parviflorum var. pubescens root (20 [hp_X]/mL) gelsemium sempervirens root (20 [hp_X]/mL) hops (20 [hp_X]/mL) hyoscyamus niger (20 [hp_X]/mL) matricaria chamomilla (20 [hp_X]/mL) oyster shell calcium carbonate, crude (20 [hp_X]/mL) passiflora incarnata flowering top (20 [hp_X]/mL) potassium bromide (20 [hp_X]/mL) scutellaria lateriflora whole (20 [hp_X]/mL) semecarpus anacardium juice (20 [hp_X]/mL) sepia officinalis juice (20 [hp_X]/mL) silver nitrate (20 [hp_X]/mL) strychnos ignatii seed (20 [hp_X]/mL) strychnos nux-vomica seed (20 [hp_X]/mL) thuja occidentalis leafy twig (20 [hp_X]/mL) valerian (11 [hp_X]/mL) wormwood (20 [hp_X]/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3f17fee1-6d69-aec2-e063-6294a90a02ed", "openfda": {"nui": ["N0000185371", "N0000185375", "N0000175629", "N0000184306", "M0000728", "M0006342", "M0016962", "M0516536", "M0008672", "N0000185001"], "unii": ["I76KB35JEV", "3SW678MX72", "S7V92P67HO", "WQZ3G9PF0H", "K73E24S6X9", "T7J046YI2B", "N20HL7Q941", "S003A158SB", "21Y9GZ1LZA", "639KR60Q1Q", "01G73H6H83", "4WRK2153H3", "G0R4UBI2ZZ", "2E32821G6I", "CLF5YFS11O", "OSD78555ZM", "7BP4DH5PDC", "Y0F0BU8RDU", "QDL83WN8C2", "95IT3W8JZE", "1NM3M2487K", "269XH13919", "1NT28V9397", "JWF5YAW3QW", "F84709P2XV"], "spl_set_id": ["c6f053fe-8b59-7226-e053-2995a90a8093"], "pharm_class_cs": ["Allergens [CS]", "Dietary Proteins [CS]", "Plant Proteins [CS]", "Seed Storage Proteins [CS]", "Food Additives [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Food Allergenic Extract [EPC]", "Non-Standardized Plant Allergenic Extract [EPC]"], "manufacturer_name": ["Newton Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, GLASS (55714-4844-1)", "package_ndc": "55714-4844-1", "marketing_start_date": "20210201"}], "brand_name": "I-Sleep", "product_id": "55714-4844_3f17fee1-6d69-aec2-e063-6294a90a02ed", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "55714-4844", "generic_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", "labeler_name": "Newton Laboratories, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "I-Sleep", "active_ingredients": [{"name": "ANEMONE PULSATILLA", "strength": "20 [hp_X]/mL"}, {"name": "ARABICA COFFEE BEAN", "strength": "20 [hp_X]/mL"}, {"name": "ARSENIC TRIOXIDE", "strength": "20 [hp_X]/mL"}, {"name": "ATROPA BELLADONNA", "strength": "20 [hp_X]/mL"}, {"name": "BLACK COHOSH", "strength": "20 [hp_X]/mL"}, {"name": "BRYONIA ALBA ROOT", "strength": "20 [hp_X]/mL"}, {"name": "CAMPHOR (NATURAL)", "strength": "20 [hp_X]/mL"}, {"name": "CINCHONA OFFICINALIS BARK", "strength": "20 [hp_X]/mL"}, {"name": "CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT", "strength": "20 [hp_X]/mL"}, {"name": "GELSEMIUM SEMPERVIRENS ROOT", "strength": "20 [hp_X]/mL"}, {"name": "HOPS", "strength": "20 [hp_X]/mL"}, {"name": "HYOSCYAMUS NIGER", "strength": "20 [hp_X]/mL"}, {"name": "MATRICARIA CHAMOMILLA", "strength": "20 [hp_X]/mL"}, {"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "strength": "20 [hp_X]/mL"}, {"name": "PASSIFLORA INCARNATA FLOWERING TOP", "strength": "20 [hp_X]/mL"}, {"name": "POTASSIUM BROMIDE", "strength": "20 [hp_X]/mL"}, {"name": "SCUTELLARIA LATERIFLORA WHOLE", "strength": "20 [hp_X]/mL"}, {"name": "SEMECARPUS ANACARDIUM JUICE", "strength": "20 [hp_X]/mL"}, {"name": "SEPIA OFFICINALIS JUICE", "strength": "20 [hp_X]/mL"}, {"name": "SILVER NITRATE", "strength": "20 [hp_X]/mL"}, {"name": "STRYCHNOS IGNATII SEED", "strength": "20 [hp_X]/mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "strength": "20 [hp_X]/mL"}, {"name": "THUJA OCCIDENTALIS LEAFY TWIG", "strength": "20 [hp_X]/mL"}, {"name": "VALERIAN", "strength": "11 [hp_X]/mL"}, {"name": "WORMWOOD", "strength": "20 [hp_X]/mL"}], "marketing_category": "UNAPPROVED HOMEOPATHIC", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}