I-Sleep

Product NDC
55714-4844
11-digit product format
557144844
Labeler code
55714
Product ID
55714-4844_3f17fee1-6d69-aec2-e063-6294a90a02ed
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
20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 11; 20 [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
IngredientStrength
ANEMONE PULSATILLA20 [hp_X]/mL
ARABICA COFFEE BEAN20 [hp_X]/mL
ARSENIC TRIOXIDE20 [hp_X]/mL
ATROPA BELLADONNA20 [hp_X]/mL
BLACK COHOSH20 [hp_X]/mL
BRYONIA ALBA ROOT20 [hp_X]/mL
CAMPHOR (NATURAL)20 [hp_X]/mL
CINCHONA OFFICINALIS BARK20 [hp_X]/mL
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT20 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT20 [hp_X]/mL
HOPS20 [hp_X]/mL
HYOSCYAMUS NIGER20 [hp_X]/mL
MATRICARIA CHAMOMILLA20 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE20 [hp_X]/mL
PASSIFLORA INCARNATA FLOWERING TOP20 [hp_X]/mL
POTASSIUM BROMIDE20 [hp_X]/mL
SCUTELLARIA LATERIFLORA WHOLE20 [hp_X]/mL
SEMECARPUS ANACARDIUM JUICE20 [hp_X]/mL
SEPIA OFFICINALIS JUICE20 [hp_X]/mL
SILVER NITRATE20 [hp_X]/mL
STRYCHNOS IGNATII SEED20 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED20 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG20 [hp_X]/mL
VALERIAN11 [hp_X]/mL
WORMWOOD20 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, 3SW678MX72, S7V92P67HO, WQZ3G9PF0H, K73E24S6X9, T7J046YI2B, N20HL7Q941, S003A158SB, 21Y9GZ1LZA, 639KR60Q1Q, 01G73H6H83, 4WRK2153H3, G0R4UBI2ZZ, 2E32821G6I, CLF5YFS11O, OSD78555ZM, 7BP4DH5PDC, Y0F0BU8RDU, QDL83WN8C2, 95IT3W8JZE

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4844-1I-Sleep30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4844I-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.]1Current NDC, Legacy NDC, 1 package rows20210713_c6f053fe-8b59-7226-e053-2995a90a8093.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4844-15571448440130 mL in 1 BOTTLE, GLASS (55714-4844-1) 30 ml2021-02-010000-00-00NoNoCurrent