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 93 of 212 · 4,232 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coffea crudaARABICA COFFEE BEANBoiron853d26eb-e3b8-4afa-e053-2a91aa0a85c32025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853da3cf-0727-a681-e053-2991aa0a67c92025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cdcd6-2dd3-8672-e053-2991aa0a55e02025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d031c-c242-bd6c-e053-2a91aa0ade262025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d2d9a-0c2c-22d0-e053-2a91aa0abaf82025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853dc617-a8b6-7626-e053-2a91aa0a9ec72025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853d570d-59ca-7e1f-e053-2a91aa0a5f1f2025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cb3dd-773a-208c-e053-2a91aa0a61892025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron755c0d20-7a53-11e6-ad11-424c583030312025-11-05Exact identifier
unii: 3SW678MX72
Coffea crudaARABICA COFFEE BEANBoiron853cdfcd-6a94-3462-e053-2a91aa0a750e2025-11-05Exact identifier
unii: 3SW678MX72
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLPranicura Products LLCaf520a58-3f3c-4d28-a41f-3ed8f74da0952025-11-04WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
San-EZ Hand SanitizerETHYL ALCOHOL 70%Dental Technologies, Inc.a2cca707-103d-7265-e053-2995a90aebfc2025-11-04WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerSDA 40B ALCOHOL 200 PROOFTropical Seas, Inc.b48f9afa-1634-e63e-e053-2a95a90a32bf2025-11-04WarningsExact identifier
unii: 3K9958V90M
PSSI E-SanALCOHOLSafe Foods Chemical Innovationsb688fc4b-620a-2caf-e053-2995a90a30772025-11-04WarningsExact identifier
unii: 3K9958V90M
PSSI E-SanALCOHOLSafe Foods Chemical Innovationsa2552024-afe9-4849-e053-2995a90a38172025-11-04WarningsExact identifier
unii: 3K9958V90M
Smarties Orange Hand Sanitizer Raspberry CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d22dff-dca4-ead3-e063-6394a90abdce2025-11-04WarningsExact identifier
unii: 3K9958V90M
Smarties Hand Sanitizer Orange CreamsicleALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42d1fdb7-0cae-edce-e063-6294a90a9a962025-11-04WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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