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 83 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OP-PEMOTIONAL HEALTH BOOSTERVitality Works, Inc.a8b87a49-fc73-4494-8dc9-059bc5f82d422025-12-17WarningsExact identifier
unii: CLF5YFS11O
Category IIMMUNE SYSTEM BOOSTERVitality Works, Inc1cbb330b-b541-457b-9a97-e17a5837d30d2025-12-17WarningsExact identifier
unii: CI71S98N1Z
Category IVIMMUNE SYSTEM BOOSTERVitality Works, Inc.790a1b3e-2b5e-426c-9c43-8674c59c9ce12025-12-17WarningsExact identifier
unii: J41CSQ7QDS
Al-InflamJOINT SUPPORTVitality Works, Inc.f1611826-16e0-403f-abee-bbf39757002f2025-12-17WarningsExact identifier
unii: CLF5YFS11O
NRV-SystemicNERVOUSE SYSTEM AIDVitality Works, Inc.f59d73be-5cb5-4fab-be62-873ea2b515dc2025-12-17WarningsExact identifier
unii: J41CSQ7QDS
CL-NEMOTIONAL HEALTH BOOSTERVitality Works, Inc.0de1e383-f721-4d2c-a1e1-946371234b882025-12-17WarningsExact identifier
unii: CLF5YFS11O
unii: G0R4UBI2ZZ
Brain SuppBRAIN SUPPORTVitality Works, Inc.4be3d5f8-f974-4ed6-ba90-f0ce08a600fe2025-12-17WarningsExact identifier
unii: JWF5YAW3QW
Earache RemedyEAR DROPSVitality Works, Inc.49afb2c3-ee42-4be9-943a-36d73ded00042025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Vital-FLBODY FLUID BALANCEVitaltiy Works, Inc.13207197-7ef7-49a3-8970-5f98299a75d22025-12-17WarningsExact identifier
unii: JWF5YAW3QW
Fem Repair Non-PregFEM GLANDULAR AND TISSUE AIDVitality Works, Inc.230fa998-20ef-46ef-8252-7ac87b58040b2025-12-17WarningsExact identifier
unii: CI71S98N1Z
ENCEMOTIONAL HEALTH BOOSTERVitality Works, Inc.2f038df1-94be-489b-8f75-10a93dcf83dd2025-12-17WarningsExact identifier
unii: J41CSQ7QDS
Sore Muscle and Joint ReliefMUSCLE AND JOINT REMEDYVitaltiy Works, Inc.3cd12d22-0fae-4a00-b026-c574e80352782025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
Gripe WaterGRIPE WATERVitality Works45ade734-f446-4370-e054-00144ff88e882025-12-17WarningsExact identifier
unii: G0R4UBI2ZZ
SlenderiixWEIGHT MANAGEMENT FORMULAVitality Works398251ec-6834-4dda-abc6-f503632d16322025-12-17WarningsExact identifier
unii: MA9CQJ3F7F
Kay Hand Sanitizer FoamETHYL ALCOHOLEcolab Inc.f82eaaaf-cead-497a-8b95-9668310511872025-12-17WarningsExact identifier
unii: 3K9958V90M
Sprayology Stress ReliefAGNUS, AVENA, CINCHONA, HUMULUS, HYOSCYAMUS, IGNATIA, PASSIFLORA, VALERIANAEight and Company L.L.C8239cbfb-256c-4bd2-9833-ab888aa3bb132025-12-17WarningsExact identifier
unii: JWF5YAW3QW
unii: 01G73H6H83
unii: MA9CQJ3F7F
unii: CLF5YFS11O
Keystone Liquid Hand SanitizerALCOHOLEcolab Inc.1d808912-f1ad-4eed-a52d-6c6a363ddba22025-12-16WarningsExact identifier
unii: 3K9958V90M
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIANatural Creations, Inccc457f87-16c5-4a52-a234-41a12989916b2025-12-16WarningsExact identifier
unii: CI71S98N1Z
unii: 3SW678MX72
unii: JWF5YAW3QW
unii: CLF5YFS11O
Sleepy Time CPACONITUM, ARSENICUM ALB, CALC CARB, COFFEA CRUDA, MAGNESIUM MET, NUX VOM, PULSATILLA, SEPIA, SULPHURNatural Creations, Inc03cbb408-7e2a-49e8-b83a-b8d932a104592025-12-16WarningsExact identifier
unii: 3SW678MX72
EcolabALCOHOLEcolab Inc.69962e54-2e1f-404a-b039-5ebf77cabd5f2025-12-16WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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