FDA.reportPublic FDA data

NDC 61096-2001-01 - SleepEase

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61096-2001
Requested NDC
61096-2001-01
Package NDCs from labels
61096-2001-1, 61096-2001-01
Manufacturer
Eight & Company L.L.C | King Bio Inc | Apotheca Company
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SleepEase - Eight & Company L.L.C | King Bio Inc | Apotheca CompanyEight & Company L.L.C | King Bio Inc | Apotheca Company2025-12-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61096-2001-12023-09-27C16284748780-1f386c64a-0f39-0266-e053-dadaa90a7c1aSleepEase
61096-2001-12023-01-30C16284748780-1f386c64a-0f39-0266-e053-dadaa90a7c1aSleepEase

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61096-2001-1SleepEase1 in 1 CARTONLIQUID16
61096-2001-1SleepEase41 mL in 1 BOTTLE, SPRAYLIQUID416

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61096-2001SLEEPEASE (AQUILEGIA, AVENA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM, HUMULUS, KALI PHOS, PASSIFLORA, VALERIANA, ZINC MET) LIQUID [EIGHT & COMPANY L.L.C]5Current NDC, Legacy NDC, 2 package rows20250519_9bd5fdc8-56b3-4e94-bd2f-1bfa9475c2e6.zip

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.

Matched openFDA labels page 44 of 216 · 4,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POTASSIUM PHOSPHATESPOTASSIUM PHOSPHATESGLENMARK PHARMACEUTICALS INC., USA70c7710c-a354-4941-bd46-e64d6ea6b5dc2026-03-20Warnings, Adverse reactionsExact identifier
unii: CI71S98N1Z
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.50ed03d9-88d1-4930-9c7d-62082bf8ce952026-03-20WarningsExact identifier
unii: 3K9958V90M
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: CI71S98N1Z
unii: J41CSQ7QDS
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd4d482f95-e192-3fef-e063-6294a90a6a402026-03-18WarningsExact identifier
unii: 3K9958V90M
Avant 70% Alcohol GelALCOHOLB4 Soap LLC241f4334-2e88-4f7b-a0c7-c93da9f5086c2026-03-18WarningsExact identifier
unii: 3K9958V90M
AdaptagenARALIA QUINQUEFOLIA, AVENA SATIVA, CAPSICUM ANNUUM, GINKGO BILOBA, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, THIAMINUM HYDROCHLORICUM, ASCORBICUM ACIDUM, RIBOFLAVINUM, GLANDULA SUPRARENALIS SUIS, SPLEEN (SUIS), THYROIDINUM (SUIS), CUPRUM GLUCONATE, IODIUM, LEDUM PALUSTRE, MOLYBDENUM METALLICUM, NATRUM CARBONICUM, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, SELENIUM METALLICUM, SEPIA, VANADIUM METALLICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUMBioActive Nutritional, Inc.9404d71c-8a2e-4e68-bf48-8536bb14fc882026-03-18WarningsExact identifier
unii: MA9CQJ3F7F
EarBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, CAPSICUM ANNUUM, CHAMOMILLA, FERRUM PHOSPHORICUM, KALI MURIATICUM, PLANTAGO MAJOR, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.82774eed-a906-4a19-86d9-05ea1462bd612026-03-18WarningsExact identifier
unii: G0R4UBI2ZZ
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepackf9f15374-4809-4b96-8a07-3c2f1011d1102026-03-18WarningsExact identifier
unii: J41CSQ7QDS
DentoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, LYMPH NODE(SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA FLUORICA, NATRUM FLUORATUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMBioActive Nutritional, Inc.dbe965b3-e81e-4328-bc41-43e875e12a052026-03-18WarningsExact identifier
unii: J41CSQ7QDS
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: MA9CQJ3F7F
Natural TestosteroneAVENA SATIVA. EPIMEDIUM, LYCOPODIUM CLAVATUM, DAMIANA, TESTOSTERONE, AGNUS CASTUSBioActive Nutritional, Inc.e2e6ce46-6729-4a63-90db-27e933379f452026-03-17WarningsExact identifier
unii: MA9CQJ3F7F
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: G0R4UBI2ZZ
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Sterillium comfortALCOHOLBODE Chemie GmbH2d48dab8-f70a-a2b5-e063-6294a90a14562026-03-16WarningsExact identifier
unii: 3K9958V90M
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.