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 99 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FinaftaBENZOCAINE, GLYCERINEfficient Laboratories Inc.03368603-3e11-c2fa-e063-6294a90a04ea2025-10-14WarningsExact identifier
unii: PDC6A3C0OX
Smart Care Barbie SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.0d6a56a0-f678-4e23-ac66-aab35c55fbf32025-10-14WarningsExact identifier
unii: 3K9958V90M
Alcohol wipes Hand Sanitizing WipesALCOHOLDGE Essentials Incd14bf315-b0fa-4d3c-9801-e28678818af92025-10-14WarningsExact identifier
unii: 3K9958V90M
Smart Care Crayola ROYAL PURPLE SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4246fbcf-7210-4767-b84b-b7b15ae767952025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care Peppa Pig SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.b0e514f4-5342-4e67-9410-c3d6ce9dc9f62025-10-13WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION HAND SANITIZER PEONY BLUSH SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO3f53a401-86d9-45d6-a526-5efd00546a032025-10-13WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SUGAR MACARON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO4d4dae53-e00b-4ce4-8e14-ba38583fdaf22025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care MY LITTLE PONY SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.073a8f7d-a1d4-4cb3-94f8-efb449f96b472025-10-13WarningsExact identifier
unii: 3K9958V90M
Smart Care TRANSFORMER SWEET PEA SCENT HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.6fe631ed-d76d-4076-ae29-e4b2133a4ef02025-10-13WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeBENZOCAINE, ALCOHOLTotal Resources International, Inc5415073f-aa1d-4ed3-aa30-7470cd2efed12025-10-10WarningsExact identifier
unii: 3K9958V90M
Lemyn Organics Medical-Grade Hand SanitizerALCOHOLLemyn LLCb106289d-346a-74df-e053-2995a90aa4262025-10-10WarningsExact identifier
unii: 3K9958V90M
Be Smart Get Prepared Sting Relief WipeALCOHOL, LIDOCAINE HYDROCHLORIDETotal Resources International, Incfff6f057-739e-40f1-8427-e1364c65af052025-10-09WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLZhejiang Hudson Import& Export Co., Ltd40b6c96c-e36f-6588-e063-6394a90adb462025-10-09WarningsExact identifier
unii: 3K9958V90M
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
unii: PDC6A3C0OX
HAND SANITIZER CHERRY ON TOPETHYL ALCOHOLPearl World Inc.218fc79e-5a57-4561-9986-f723dc12928d2025-10-09WarningsExact identifier
unii: 3K9958V90M
DigiSanALCOHOLEcolab Inc.aa921967-cd15-4bc2-9452-7637462747022025-10-09WarningsExact identifier
unii: 3K9958V90M
365 Spiced Balsam Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10cd38f9-dbe0-8bea-e063-6294a90a39872025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Winterberry Saffron Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10bc43da-460a-d30d-e063-6294a90a49402025-10-08WarningsExact identifier
unii: 3K9958V90M
365 Spiced Citrus Hand Sanitizer WipesALCOHOL HAND SANITIZERWhole Foods Market, Inc.10d096e7-3fb9-6122-e063-6294a90a20c02025-10-08WarningsExact identifier
unii: 3K9958V90M
North Woods Derma Gel ClearALCOHOLSuperior Chemical Corporationabbd099a-8d89-80a0-e053-2a95a90a24fc2025-10-08WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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