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 86 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand SanitizerHAND SANITIZERZhejiang Meimi Technology Co., Ltd.dced643b-96fb-193f-e053-2a95a90a16aa2025-12-06WarningsExact identifier
unii: 3K9958V90M
Cough and Bronchial Nighttime SyrupACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe Mexico S.A. DE C.V.00d38f6f-dbab-4bbd-84b5-9807ea9073f82025-12-04WarningsExact identifier
unii: 3SW678MX72
Mrs. Meyers Clean Day Hand Sanitizer Basil ScentALCOHOLThe Caldrea Companyd263d012-997c-4029-b771-e8f346da59882025-12-04WarningsExact identifier
unii: 3K9958V90M
El Valle Decolorized IodineALCOHOLPharmadel LLCfd7a227b-536c-b3f7-e053-6394a90a41582025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen, Pink Kiwi Splash ScentedALCOHOLFourstar Group USA, Inc.f8b8b820-467b-49eb-8bec-16d39ba32e962025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid, Berries and Cream ScentedALCOHOLFourstar Group USA, Inc.9b646c4e-69e7-44c2-afa3-8267c25e62022025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.08d9499c-486c-464b-9d81-ba325b95482e2025-12-04WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Palm Sugar Pineapple ScentedALCOHOLFourstar Group USA, Inc.34d065a1-c5f0-4ba0-8c1b-717049dcb83a2025-12-04WarningsExact identifier
unii: 3K9958V90M
FoamFresh Alco-Foam Hand SanitizerALCOHOLWoodbine Products Company2e9c752c-ad69-4692-a17a-e98b84c7e9a52025-12-04WarningsExact identifier
unii: 3K9958V90M
Nightime Cough and BronchialACONITUM NAPELLUS, BRYONIA ROOT, CALCIUM CATION, SPONGIA OFFICINALIS SKELETON, ROASTED, TIN, MEDICAGO SATIVA LEAF, OAT, ARABICA COFFEE BEANSchwabe North Americab3899e48-2db8-4deb-b976-eb143b6223dd2025-12-04WarningsExact identifier
unii: 3SW678MX72
Mrs. Meyers Clean Day Hand Sanitizer Lavender ScentALCOHOLThe Caldrea Companyd60a985b-6b42-44ea-b48e-81556e4f609a2025-12-04WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Jasmine GardeniaALCOHOLShenzhen Lantern Scicence Co.,Ltd.45082749-6f53-c595-e063-6294a90ac3e92025-12-03WarningsExact identifier
unii: 3K9958V90M
Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHumco Holding Group, Inc.41c0927e-df40-4f83-8fd4-284ec0c02b602025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer StrawberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.451752d3-88bc-9a26-e063-6294a90a288a2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Floral Fresh (Lavender/Wild rose/Rain)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.45179a84-fa3c-5634-e063-6294a90a0eee2025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk - Classic Men (Ocean/Sandalwood/Cedar and cypress)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.451711f3-3b22-5d39-e063-6294a90a78942025-12-03WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer 3pk (Pistachio Brulee / Vanilla Shea /Caramel Honey)ALCOHOLShenzhen Lantern Scicence Co.,Ltd.4518038c-04ac-0fbe-e063-6294a90a7c322025-12-03WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerANTISEPTIC GELHART Health87fcd27f-e4bf-4ae9-ad2e-b9b11ac554cc2025-12-02WarningsExact identifier
unii: 3K9958V90M
Hand sanitizerHAND SANITIZER SPRAYGuangzhou Baihua Co., Ltd44f609dd-c864-493f-e063-6294a90a71382025-12-02WarningsExact identifier
unii: 3K9958V90M
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: CI71S98N1Z

Reported adverse events (FAERS/openFDA)#

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