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 112 of 210 · 4,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a1d0f0b-e330-f674-e063-6394a90aec492025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLMY IMPORTS USA LLC3a2a1165-b710-3bf6-e063-6294a90a352d2025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Cranberry SageETHYL ALCOHOLMY IMPORTS USA LLC3a2a36bb-c55d-67a0-e063-6294a90a1cf42025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Mango Peach SplashETHYL ALCOHOLMY IMPORTS USA LLC3a2a4539-30eb-7451-e063-6294a90a2c222025-07-17WarningsExact identifier
unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Sweet Floral MorningETHYL ALCOHOLMY IMPORTS USA LLC3a2a4fab-6776-7359-e063-6294a90a85242025-07-17WarningsExact identifier
unii: 3K9958V90M
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX
AshleyBelle Moisturizing Hand Sanitizer Coconut SandalwoodETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.3a186822-025c-6970-e063-6394a90a5dc12025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care WILD ROSE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.e98e8f32-94f9-45b6-94b3-93c62a8a3f172025-07-16WarningsExact identifier
unii: 3K9958V90M
Smart Care CALMING LAVENDER HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.38a7d367-7a33-48dc-84e7-fce894bf79fa2025-07-16WarningsExact identifier
unii: 3K9958V90M
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: J41CSQ7QDS
Smart Care FRESH RAIN HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dfdd5255-9033-4a22-a03c-922c3a33d24d2025-07-15WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Lovely Lavender Scent HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.73695c5e-664c-466f-9d84-ae4b115da23f2025-07-15WarningsExact identifier
unii: 3K9958V90M
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
Dehydrated AlcoholDEHYDRATED ALCOHOLIngenus Pharmaceuticals, LLC1d5ec6f9-d58f-4651-a4a1-93fec13fd4382025-07-11Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: CI71S98N1Z
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a417a8-afec-f893-e063-6394a90a70ae2025-07-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a4aecf-1e74-4589-e063-6394a90a34fb2025-07-11WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd39a57c83-5ea6-5b36-e063-6294a90a284d2025-07-11WarningsExact identifier
unii: 3K9958V90M
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
Signature Select isopropyl alcohol wipesALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.97272c57-88f0-40d9-b11f-d53cb806ee732025-07-04WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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