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 46 of 216 · 4,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Hand Sanitizing WipesETHYL ALCOHOLUpLift Brands, LLCca7c6243-dc7f-40c4-8b51-ec9a7c1f14f52026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLUpLift Brands, LLCba4be8c2-00ce-48e6-a83c-6c1bde3c3aa42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLUpLift Brands LLCf6608379-051f-4151-bcf7-ecd87070f4392026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCa1954926-35f6-439e-863f-29351013e5542026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands LLCdd569334-0280-49d6-afcf-0c49ed316cb92026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCef02b350-1a37-42d4-8eaa-38a2de5e41eb2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Moisturizing Hand SanitizerETHYL ALCOHOLUpLift Brands, LLCbf53255d-18d7-4672-8139-bacc5cb1a2e62026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLUpLift Brands, LLC03ed8a06-33aa-4893-824c-a3843962de3d2026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand Sanitizer with AloeETHYL ALCOHOLUpLift Brands, LLC62cfbf46-9c12-487f-81d9-a1f839402ec42026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
ETHYL ALCOHOLETHYL ALCOHOLUpLift Brands, LLC42b1aff5-d788-0d46-e063-6294a90a02d32026-03-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
RelaxoforceHUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, CALCAREA CARBONICA, COFFEA TOSTA, IGNATIA AMARA, KALI PHOSPHORICUM, MOSCHUS, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS)BioActive Nutritional, Inc.141fb6b7-08d9-4b57-bafd-ba5c8f98914e2026-03-11WarningsExact identifier
unii: CI71S98N1Z
unii: JWF5YAW3QW
unii: 01G73H6H83
unii: CLF5YFS11O
VARICO HPCALCAREA FLUORICA, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, STAPHYSAGRIA, ZINCUM METALLICUMBioActive Nutritional, Inc.4d5354a8-52cf-4ad9-b5f7-f9207b0a5cd42026-03-11WarningsExact identifier
unii: J41CSQ7QDS
NeurotonePASSIFLORA INCARNATA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARNICA MONTANA, HYPERICUM PERFORATUM, LACHESIS MUTUS, MUIRA PUAMABioActive Nutritional, Inc.5007c3b2-0552-439e-b47a-681ba4a23b402026-03-11WarningsExact identifier
unii: CLF5YFS11O
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: G0R4UBI2ZZ
No More MonstersCALCAREA CARBONICA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PASSIFLORA INCARNATA, GALLICUM ACIDUMNaturalCarec28be233-b4d1-42c6-bc63-3cd276aec5bb2026-03-10WarningsExact identifier
unii: CI71S98N1Z
unii: CLF5YFS11O
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
unii: G0R4UBI2ZZ
unii: J41CSQ7QDS
Anti Bacterial Hand Gel Whipped Vanilla CloudsALCOHOLBath & Body Works, Inc.46178c56-3e33-4523-e063-6394a90aca792026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Blue Raspberry FreezeALCOHOLBath & Body Works, Inc.4616db35-113d-970f-e063-6394a90aa38d2026-03-10WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Pistachio Milk and HoneyALCOHOLBath & Body Works, Inc.4616f2ce-1b5e-436d-e063-6394a90acbe22026-03-10WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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