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 103 of 211 · 4,210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer Sunrise CitrusALCOHOLScent Theory Products LLC3f8fd236-e415-30f8-e063-6394a90a4c962025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Velvet VanillaALCOHOLScent Theory Products LLC3f8fdb54-2e2c-2cab-e063-6394a90a1f092025-09-24WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer Sun-Kissed MelonALCOHOLScent Theory Products LLC3f8fe3c4-1373-b45a-e063-6294a90ae05b2025-09-24WarningsExact identifier
unii: 3K9958V90M
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
unii: PDC6A3C0OX
Unishield Hand SanitizerETHYL ALCOHOLUnishieldeae1fc97-eb39-4353-adfa-7c549d50b5db2025-09-24WarningsExact identifier
unii: 3K9958V90M
Smart Care WATERMELON HAND SANITIZERETHYL ALCOHOLAshtel Studios Inc.dd40b8d2-7b6e-4bfc-8a52-a852c3ffe45b2025-09-24WarningsExact identifier
unii: 3K9958V90M
First Aid Direct Hand SanitizerHAND SANITIZERCintas Corporationdad0fc5d-4a48-4db1-b423-558c2958750c2025-09-24WarningsExact identifier
unii: 3K9958V90M
Tendersant Hand SanitizerALCOHOLGeri-Gentle Corporationb09d568a-4c9d-5804-e053-2a95a90ab8ea2025-09-23WarningsExact identifier
unii: 3K9958V90M
Panic EaseACONITUM NAP., APIS MEL., ARNICA, ARSENICUM ALB., BELLADONNA, BELLIS, BRYONIA, CALENDULA, CHAMOMILLA, CISTUS CANADENSIS, FERRUM PHOSPHORICUM, HISTAMINUM HYDROCHLORICUM, HYPERICUM, IGNATIA, MEZEREUM, ORNITHOGALUM, PASSIFLORA, PHOSPHORUS, PRUNUS SPIN., RHUS TOXICODENDRON, SARCOLACTICUM AC., SULPHUR, VERATRUM ALB., VALERIANA.Newton Laboratories, Inc.9971a152-0706-8166-e053-2995a90aab9f2025-09-23WarningsExact identifier
unii: JWF5YAW3QW
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Smart Care VANILLA SUGAR HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.bad645e8-4f99-4629-9259-9ae856e16d302025-09-22WarningsExact identifier
unii: 3K9958V90M
Blood LiquescenceALLIUM CEPA, HYSSOPUS OFFICINALIS, AVENA SATIVA, PALOONDO, URTICA DIOICA, TRIFOLIUM PRATENSE, ZINGIBER OFFICINALE, CAPSICUM ANNUUM, HEPAR (BOVINE), HYPOPHYSIS SUIS, JUGLANS REGIA, MEDULLA OSSIS SUIS, REMEX CRISPUS, SPLEEN (BOVINE), CAMPHORA, MAGNESIA PHOSPHORICA, FERRUM PHOSPHORICUM, PYROGENIUMNutritional Specialties, Inc.42f57741-8d47-4e50-a8fb-adfc73453ed22025-09-22WarningsExact identifier
unii: MA9CQJ3F7F
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e04b42dd-68ce-44d9-be1b-c4a5d9a646612025-09-19WarningsExact identifier
unii: 3K9958V90M
Smart Care HAND SANITIZER - CUCUMBER MELON FLAVORETHYL ALCOHOLAshtel Studios Inc.153a921a-a721-4320-8b86-cfed1ea511272025-09-19WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.3f2b75d8-89f1-8d67-e063-6294a90a01662025-09-19WarningsExact identifier
unii: G0R4UBI2ZZ
meijer LAKESHORE FRESH SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.f0214101-0800-4ac2-a622-38192eeec5e32025-09-19WarningsExact identifier
unii: 3K9958V90M
meijer PINE FOREST SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.bb81ef16-bb89-4a1a-a8f9-305c5e7468c82025-09-19WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.a67aef1b-c0b2-4626-b89b-58a6b56efe1c2025-09-19WarningsExact identifier
unii: 3K9958V90M
I-SleepABSINTHIUM, ANACARDIUM ORIENTALE, ARG. NIT., ARSENICUM ALB., BELLADONNA, BRYONIA, CALC. CARB., CAMPHORA, CHAMOMILLA, CIMICIFUGA, CINCHONA, COFFEA CRUDA, CYPRIPEDIUM, GELSEMIUM, HUMULUS, HYOSCYAMUS, IGNATIA, KALI BROM., NUX VOM., PASSIFLORA, PULSATILLA, SCUTELLARIA LATERIFLORA, SEPIA, THUJA OCC., VALERIANANewton Laboratories, Inc.c6f053fe-8b59-7226-e053-2995a90a80932025-09-18WarningsExact identifier
unii: 3SW678MX72
unii: JWF5YAW3QW
unii: 01G73H6H83
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
unii: 21Y9GZ1LZA
MISTIFY SANITIZER WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd3efef0a5-ff5e-f2b0-e063-6294a90a1efa2025-09-17WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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