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 119 of 210 · 4,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Hand Sanitizer Sugar Cookie ScentedALCOHOLFOURSTAR GROUP USA, INC.29448472-af23-4ed2-93a9-9d57b7d8d0812025-05-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Ginger Citrus ScentedALCOHOLFOURSTAR GROUP USA, INC.100184a8-6298-4c57-a831-cd5fa55a66b02025-05-07WarningsExact identifier
unii: 3K9958V90M
meijer WATERMELON SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.9dc31149-9ba1-4014-9a51-21e558652ca52025-05-06WarningsExact identifier
unii: 3K9958V90M
meijer BERRY SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.7bbd6459-0cb6-4b48-b842-0d585295ed802025-05-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Mocha Coffee ScentedALCOHOLFOURSTAR GROUP USA, INC.8130954d-ba43-478d-b260-b74eaa2ab3752025-05-05WarningsExact identifier
unii: 3K9958V90M
Jacksons Cell Salts KALI PHOS 6X 10KALI PHOSPHORICUMZettl Health Inc.3467dac6-887e-3677-e063-6294a90a21bb2025-05-05WarningsExact identifier
unii: CI71S98N1Z
B-Pure Moisturizing Hand Sanitizer Almond Vanilla ScentedALCOHOLFOURSTAR GROUP USA, INC.e9628d75-6271-47f7-8e96-cc06b2496b3b2025-05-05WarningsExact identifier
unii: 3K9958V90M
Nozin Nasal Sanitizer (Antiseptic)ALCOHOLGlobal Life Technologies Corp.c670ac11-0656-4d85-868e-3a407c9952a32025-05-05WarningsExact identifier
unii: 3K9958V90M
Mt Royal Hand Sanitizer70% ETHYL ALCOHOL GELMount Royal Soaps, LLCa25f5362-b868-5f47-e053-2995a90a05a72025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VANILLAALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a703b9-bcec-55ab-e063-6294a90af7822025-05-01WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd36a73f9f-faa2-89d5-e063-6294a90a4e0c2025-05-01WarningsExact identifier
unii: 3K9958V90M
Sterillium MedALCOHOLBODE Chemie GmbH8d80d5fd-7869-c551-e053-2995a90af2a92025-04-30WarningsExact identifier
unii: 3K9958V90M
Sterillium ComfortALCOHOLBODE Chemie GmbH8efc9f4e-3b20-60ba-e053-2995a90af8b12025-04-30WarningsExact identifier
unii: 3K9958V90M
Ear RingALLIUM CEPA, ARGENTUM NITRICUM, ASARUM CANADENSE, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, CARTILAGO SUIS, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CYCLAMEN EUROPAEUM, DULCAMARA, GINKGO BILOBA, GRAPHITES, KREOSOTUM, MUCOSA NASALIS SUIS, NATRUM SALICYLICUM, PHOSPHORUS, PLUMBUM METALLICUM, THERIDION, ZINCUM METALLICUMDeseret Biologicals, Inc.c4b66b0a-fb00-4047-af7e-b5b0f2327f2f2025-04-29WarningsExact identifier
unii: J41CSQ7QDS
FRESH FEELS HAND SANITIZER MIST BLUE RASPBERRY SCENTETHYL ALCOHOLPearl World Inc.106955cd-4485-4a0b-87a2-d4343e6a89f62025-04-29WarningsExact identifier
unii: 3K9958V90M
ThroatSprayECHINACEA (ANGUSTIFOLIA), EUGENIA CARYOPHYLLATA, GLYCERINUM, MYRRHA, SALVIA OFFICINALIS, SPILANTHES OLERACEA, THYMUS SERPYLLUM, BAPTISIA TINCTORIA, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, LACHESIS MUTUS, MERCURIUS SOLUBILIS, HEPAR SULPHURIS CALCAREUMEnergique, Inc.125ffbf4-681e-451c-a96d-0b64166194742025-04-29WarningsExact identifier
unii: PDC6A3C0OX
FRESH FEELS HAND SANITIZER MIST GUMMY BEAR SCENTETHYL ALCOHOLPearl World Inc.f8e02860-0e21-4e5c-b2fc-1340d145afe02025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BUBBLE TEA SCENTETHYL ALCOHOLPearl World Inc.f0fbe51f-3402-42a1-8364-8e3f2e35ee662025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST MANGO SCENTETHYL ALCOHOLPearl World Inc.33123052-f8e6-433d-9734-05e21ecc0e622025-04-29WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST PEAR SPLASH SCENTETHYL ALCOHOLPearl World Inc.20f9d364-9386-4d60-9c60-13c5819588602025-04-29WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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