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 60 of 216 · 4,304 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerETHYL ALCOHOLUline3bc9cfa2-2b1f-4892-93ff-cffa9f5878042026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLUlinefdda41fa-d847-4cee-a070-91f0600b0fc82026-02-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel The Upside DownALCOHOLBath & Body Works, Inc.29a539bb-42e7-dc73-e063-6394a90a5fe92026-02-17WarningsExact identifier
unii: 3K9958V90M
INSTACLEAN HAND SANITIZINGALCOHOLSHIELD LINE LLC6d606fae-d95e-cffc-e053-2991aa0a988b2026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Sunshine and LemonsALCOHOLBath & Body Works, Inc.38d661c8-6f48-f58c-e063-6294a90ae8c12026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Champagne ToastALCOHOLBath & Body Works, Inc.38951f0d-0ec4-2406-e063-6394a90a9fe32026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Strawberry Pound CakeALCOHOLBath & Body Works, Inc.38d656e3-5f8f-9874-e063-6394a90a8ea52026-02-17WarningsExact identifier
unii: 3K9958V90M
Anti Bacterial Hand Gel Eucalyptus MintALCOHOLBath & Body Works, Inc.38d65eae-f1af-f342-e063-6294a90af7fe2026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBGENERATION Hand Sanitizer OCEAN BREEZE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO2cf4bc63-6157-4c4f-bb52-aa685f8d4aee2026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer WATERMELON SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO15a5272c-0abc-47e1-be21-91a601ead3082026-02-17WarningsExact identifier
unii: 3K9958V90M
AURA LANE HAND SANITIZER Neroli Flower ScentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO1cd1c0ee-1849-4003-a128-323d1b06aa402026-02-17WarningsExact identifier
unii: 3K9958V90M
hand sanitizer chocolate chip pancake scentETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO105d2927-59e1-46fb-ad48-ea45ed3051e82026-02-17WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer MANDARIN ORANGE SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO20a8d48d-aa4b-4904-84e9-54be5ddb43a02026-02-17WarningsExact identifier
unii: 3K9958V90M
BCBG GENERATION Hand Sanitizer FRESH GUAVA SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO9eece9a7-3340-47ea-98aa-152d285e4c012026-02-16WarningsExact identifier
unii: 3K9958V90M
SOUR LEMON Hand Sanitizer SWEET CHERRY SCENTETHYL ALCOHOLDiamond Life Cosmetics Trading FZCO990a5e7b-8fe4-4681-99eb-76445f9436a72026-02-16WarningsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLC490a3484-04d7-4a90-b203-71971a869e8d2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLAmazon.com Services LLCe1bd99f5-8a96-442a-8c70-367df96c5cf02026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLVeritiv Operating Company3b8a41b3-54c5-f5c0-e063-6394a90a9fac2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLValu Merchandisers Company722abec8-5a05-4e6d-a7ea-da9d1009e8592026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Advanced Hand SanitizerETHYL ALCOHOLValu Merchandisers Companye8b82c44-cbe0-42b2-b920-fed8da8f79eb2026-02-16Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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