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 80 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORA Hand Sanitizer Mist CherryETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.46bf95f1-a76e-c810-e063-6394a90a6e952025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST VANILLA BREEZE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited82d9ae31-d6bc-4c74-8add-c4a2a4902c2a2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MINT CHOCOLATE CHIP ICE Cream SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedfa471391-2023-4b3a-b8f5-114dd93f9fe32025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST SEASHELL SUNSHINE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited04952291-f74a-4a3b-8d7c-12f83593496d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BEACH COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedccecaff5-8bd5-490e-8c73-a06991fa754e2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST STRAWBERRY SHORTCAKE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited8c7fda8c-720f-413b-a4f5-cd8e9169ed6d2025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST LYCHEE PEACHY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited9c62c74e-c69a-4fcf-8f4c-ec03a0bbf0272025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PAPAYA SUNSET SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitede998c88b-5a23-42e8-bdc1-6591ee62fb852025-12-24WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PINK GUAVA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited2a6f551b-2e2a-4788-b522-c1c7654491172025-12-24WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.56ac723b-3ede-4c94-bf4a-0572a7b42b592025-12-23WarningsExact identifier
unii: 3K9958V90M
MG FoamSan 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.11fc23dd-80e1-4df1-8c19-f759ecb34f1a2025-12-23WarningsExact identifier
unii: 3K9958V90M
TazzaETHANOLTazza Brands East Inc.391cc18f-ce63-5d88-e054-00144ff88e882025-12-23WarningsExact identifier
unii: 3K9958V90M
MG DermaGel 62 LVETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.437a508d-31ba-49b4-b821-4bf57b596e332025-12-23WarningsExact identifier
unii: 3K9958V90M
Alcare Plus Foamed Antiseptic HandrubALCOHOLSC Johnson Professional USA, Inc.56900a58-b586-41e5-8b66-c9a006a79a9b2025-12-22WarningsExact identifier
unii: 3K9958V90M
Equate Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINHanlim46851e7c-8910-6456-e063-6394a90abafb2025-12-22WarningsExact identifier
unii: PDC6A3C0OX
Endopath-MADENOSINUM CYCLOPHOSPHORICUM, AGNUS CASTUS, ASPARAGUS OFFICINALIS, AVENA SATIVA, CADMIUM METALLICUM, DAMIANA, GLANDULA SUPRARENALIS SUIS, JUNIPERUS COMMUNIS, LYCOPODIUM CLAVATUM, ORCHITINUM (BOVINE), PETROSELINUM SATIVUM, PITUITARUM POSTERIUM (BOVINE), PULSATILLA (VULGARIS), SABAL SERRULATA, SARSAPARILLA (SMILAX REGELII)Energetix Corporationece117c4-5116-458e-888a-5ff3cf0cfbfb2025-12-22WarningsExact identifier
unii: MA9CQJ3F7F
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: G0R4UBI2ZZ
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: G0R4UBI2ZZ
Hand Sanitizer Pear Blossom TeaALCOHOL SOLUTIONNoshinku46927edb-f8be-f0b9-e063-6294a90a8e562025-12-22WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Santal BlancALCOHOL SOLUTIONNoshinku4692c807-268e-6477-e063-6394a90aac0a2025-12-22WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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