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 45 of 216 · 4,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO17CALC FLUOR, FERR PHOS, KALI MUR, KALI PHOS.BM Private Limited4d22be93-c5f9-6ef3-e063-6294a90a7a8f2026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO26CALC FLUOR, CALC PHOS, KALI PHOS, MAG PHOS.BM Private Limited4d2480f4-e2df-5cf0-e063-6394a90a1bde2026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO7CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULF.BM Private Limited4d260c2a-9218-17d0-e063-6394a90a62b72026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO24CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.BM Private Limited4d277580-9a76-ae86-e063-6394a90a20e92026-03-16WarningsExact identifier
unii: CI71S98N1Z
Limited Edition Hand Sanitizer Pink Satin ProseccoALCOHOLScent Theory Products LLC4d278204-9331-aeb8-e063-6394a90a87a42026-03-16WarningsExact identifier
unii: 3K9958V90M
Limited Edition Hand Sanitizer Cherry ChaiALCOHOLScent Theory Products LLC4d27a964-6e91-27c0-e063-6294a90ad9942026-03-16WarningsExact identifier
unii: 3K9958V90M
BM BIO15CALC PHOS, KALI PHOS, FERR PHOS, KALI SULPH, MAG PHOSBM Private Limited4d223d3d-bb49-8d66-e063-6394a90a0c7b2026-03-16WarningsExact identifier
unii: CI71S98N1Z
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSBM Private Limited4d2948fd-ac6b-f43f-e063-6394a90a747d2026-03-16WarningsExact identifier
unii: CI71S98N1Z
Sterillium FoamALCOHOLBODE Chemie GmbH93680cd8-609f-48f2-e053-2995a90aa3552026-03-16WarningsExact identifier
unii: 3K9958V90M
Sterillium rub fragrance-freeALCOHOLBODE Chemie GmbH2bc46854-fe65-782b-e063-6294a90a79af2026-03-16WarningsExact identifier
unii: 3K9958V90M
HealthWise Advanced Hand Sanitizer with LavenderETHYL ALCOHOL 70%Veridian Healthcare4d144fb3-b4b7-135f-e063-6394a90a366e2026-03-15WarningsExact identifier
unii: 3K9958V90M
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: CI71S98N1Z
Hand SanitizerALCOHOLNice-Pak Products, LLC9bed5445-3e25-43e8-840a-9e3443b5a8512026-03-13Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: CI71S98N1Z
Hand SanitizerALCOHOLProStat First Aid4cd4c51c-88bb-3797-e063-6294a90a8f702026-03-12WarningsExact identifier
unii: 3K9958V90M
Limited Edition Hand Sanitizer Cashmere SkinALCOHOLScent Theory Products LLC4cdc4282-eb49-3120-e063-6294a90a2d612026-03-12WarningsExact identifier
unii: 3K9958V90M
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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