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 72 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Formula III Drops 2091PAIN FORMULA III DROPSProfessional Complementary Health Formulas3d95fb9c-c3ce-4b66-93d0-04bddae799222026-01-08WarningsExact identifier
unii: JWF5YAW3QW
Irregular Pulse Drops 2036IRREGULAR PULSE DROPSProfessional Complementary Health Formulasae709e30-7b33-4300-b46c-ff649a16900e2026-01-08WarningsExact identifier
unii: JWF5YAW3QW
Glycerin Combination 9304GLYCERIN COMBINATIONProfessional Complementary Health Formulas391d8517-9b89-4b62-97b5-5102b35bec462026-01-08WarningsExact identifier
unii: PDC6A3C0OX
Myocardial Drops 5016MYOCARDIAL DROPSProfessional Complementary Health Formulas23ca328e-cd71-49bb-b289-fcf50e3846b42026-01-08WarningsExact identifier
unii: JWF5YAW3QW
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: JWF5YAW3QW
unii: MA9CQJ3F7F
Echinacea Combination 9222ECHINACEA COMBINATIONProfessional Complementary Health Formulas430cc9f6-5565-4345-ac5f-d948fb3b14bd2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Magnesium Combination 9232MAGNESIUM COMBINATIONProfessional Complementary Health Formulas4d99b3ec-724f-4385-ae5e-83389bb0c8fe2026-01-08WarningsExact identifier
unii: CLF5YFS11O
Libido Stim Liquescence 3014LIBIDO STIM LIQUESCENCEProfessional Complementary Health Formulas3d59b77d-817b-4021-a6dd-75d3b4b608662026-01-08WarningsExact identifier
unii: PDC6A3C0OX
unii: CLF5YFS11O
Rehydration Drops 2175REHYDRATION DROPSProfessional Complementary Health Formulas58cc2bd1-c530-43bf-876e-f30d4d95b8da2026-01-08WarningsExact identifier
unii: 3SW678MX72
Sleep Disorder Drops 2152SLEEP DISORDER DROPSProfessional Complementary Health Formulas55af88df-8e5a-4e84-a8f6-fc3063d913812026-01-08WarningsExact identifier
unii: CLF5YFS11O
Pineal Liquescence 3030PINEAL LIQUESCENCEProfessional Complementary Health Formulas3574f919-0b93-4bf5-9ee9-8fadda5668c32026-01-08WarningsExact identifier
unii: JWF5YAW3QW
unii: J41CSQ7QDS
Ledum Combination 9257LEDUM COMBINATIONProfessional Complementary Health Formulas38b89b32-4915-487d-8b2d-250123487b152026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Stress Tonic 2998STRESS TONICProfessional Complementary Health Formulas1f53201a-427a-4342-b510-890c33b9c4c62026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Melancholy Drops Introvert 2016MELANCHOLY DROPS INTROVERTProfessional Complementary Health Formulas60e305b4-bb1f-465e-963d-38e6b38df98d2026-01-08WarningsExact identifier
unii: CLF5YFS11O
Restless Leg Drops 2172RESTLESS LEG DROPSProfessional Complementary Health Formulas73822225-f10c-4d2a-8cd8-ea31dd2b27892026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Valeriana Combination 9249VALERIANA COMBINATIONProfessional Complementary Health Formulas6062a6e8-c570-4099-9256-73db7936f12a2026-01-08WarningsExact identifier
unii: JWF5YAW3QW
unii: 01G73H6H83
unii: MA9CQJ3F7F
Fertility Drops 2174FERTILITY DROPSProfessional Complementary Health Formulas78985992-bb47-4045-82f3-a6094e48d50a2026-01-08WarningsExact identifier
unii: 21Y9GZ1LZA
Dementia Drops 2117DEMENTIA DROPSProfessional Complementary Health Formulas83aec02b-bc62-49a2-ba35-4ac94f9bfc6e2026-01-08WarningsExact identifier
unii: J41CSQ7QDS
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: JWF5YAW3QW
EcoChoice Sterno Hand Sanitizer Lemon ZestALCOHOLSTERNO PRODUCTS, LLC576b7579-f44d-4315-a9c6-09d9a6d3f61d2026-01-07WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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