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 97 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizing WipesETHYL ALCOHOLPHOENIX HEALTHCARE SOLUTIONS, LLCca9f8e68-cc15-42b4-81fd-e114e6a6d7df2025-10-23WarningsExact identifier
unii: 3K9958V90M
Lemon Glycerine SwabsticksGLYCERINEPHOENIX HEALTHCARE SOLUTIONS, LLC436919f7-14cd-4318-9388-b3e1cbec176b2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
CareTouchETHYL ALCOHOLFuture Diagnostics Llc45f6a1da-f0ab-4783-a211-7fba5dc0530e2025-10-23WarningsExact identifier
unii: 3K9958V90M
Miranda Castros Phosphorus 5 Cell Salts For Physical and Emotional Fatigue, Stress and TensionCALCAREA PHOS, FERRUM PHOS, KALI PHOS, MAGNESIUM PHOS, NATRUM PHOSMIRANDA CASTRO'S SHOP, LLC2670fdeb-0c80-9f23-e063-6394a90a8c6a2025-10-23WarningsExact identifier
unii: CI71S98N1Z
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: PDC6A3C0OX
Koala Eco Hand SanitizerETHYL ALCOHOLKoala Eco Company USA Ltd41d7d6e3-9961-770d-e063-6394a90a0d242025-10-23WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Refresh Relieva Preservative FreeCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.3481f9b3-5a90-40d3-80f8-81f51cc864be2025-10-22WarningsExact identifier
unii: PDC6A3C0OX
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
unii: 3K9958V90M
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERMETHOD PHARMACEUTICALS, LLC1f8785db-3e65-49d7-b017-b1a65b5ec6b12025-10-21WarningsExact identifier
unii: J41CSQ7QDS
meijer STRAWBERRY SHORTCAKE SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.5b326af5-218f-4de5-9d43-9dcd0d5e8a252025-10-21WarningsExact identifier
unii: 3K9958V90M
meijer LEMON SORBET SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.ef1dc7d8-38a7-4d12-a7e5-2dd1e82632102025-10-21WarningsExact identifier
unii: 3K9958V90M
WIDESPREAD Hand Sanitizing WipesALCOHOLHAMAOUI TRADING CORP.417df1ac-fa23-4d99-e063-6294a90a7d0f2025-10-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
unii: 3K9958V90M
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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