FDA.reportPublic FDA data

NDC 44038-0322 - HISMILE

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
44038-0322
Package NDCs from labels
44038-0322-1
Manufacturer
Accupac LLC
Effective date
2024-09-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HISMILE - Accupac LLCAccupac LLC2024-09-18HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44038-0322HISMILE (SODIUM FLUORIDE) GEL [ACCUPAC LLC]2Unmatched20240921_22794069-382d-b71d-e063-6394a90aef6d.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 53 of 79 · 1,564 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DawnMistTOOTHPASTEDukal LLC147f7738-5080-9907-e063-6294a90a61702025-02-07WarningsExact identifier
unii: 8ZYQ1474W7
DawnMist Gel FluorideGEL FLUORIDE TOOTHPASTEDukal LLC14443184-1694-70b9-e063-6394a90a86fe2025-02-07WarningsExact identifier
unii: 8ZYQ1474W7
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Tyson 2.0 Mike Red Eye Drops For Dry High EyesGLYCERIN, NAPHAZOLINE HCLJbrands Pharma L.L.C.288e9c85-0562-89bf-e063-6394a90a110d2025-02-07WarningsExact identifier
unii: PDC6A3C0OX
AN12 Secret Therapy Feminine CleanserGLYCERINBESTVALUE Co., Ltdd2117c4c-9f1a-3a6e-e053-2995a90a0cc82025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 Skin Therapy Vita-B Aloe Soothing GelGLYCERINBESTVALUE Co., Ltdd274c973-057d-1c9f-e053-2995a90a82b12025-01-31WarningsExact identifier
unii: PDC6A3C0OX
AN12 ANUS PREMIUM CLEANSERGLYCERIN, ALLANTOINBESTVALUE Co., Ltdd11b7443-2dfc-3e17-e053-2a95a90afb762025-01-31WarningsExact identifier
unii: PDC6A3C0OX
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Quip Anticavity Fluoride ConcentrateSODIUM FLUORIDEQuip NYC Inc.b3da65bb-0871-34e7-e053-2a95a90a310e2025-01-30WarningsExact identifier
unii: 8ZYQ1474W7
FLUORIDEXSODIUM FLUORIDEDENT-MAT HOLDINGS, LLC.601774d5-f4de-01bc-e053-2991aa0a7f4f2025-01-30Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d4cfe3-535e-9163-e053-2a95a90ae1402025-01-30WarningsExact identifier
unii: 8ZYQ1474W7
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a2025-01-30WarningsExact identifier
unii: 8ZYQ1474W7
QuipSODIUM FLUORIDEQuip NYC Inc.714b7205-444d-929b-e053-2995a90a958e2025-01-30WarningsExact identifier
unii: 8ZYQ1474W7
meijer Sensitive FRESH MINTPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bea36d55-1a5d-40c0-b422-92fb36043ee62025-01-23WarningsExact identifier
unii: 8ZYQ1474W7
Cool sense Care PlusSODIUM FLUORIDEDOCSMEDI Co., Ltd.ea18ac56-4ef1-4bf0-8c26-6885183fd6842025-01-22WarningsExact identifier
unii: 8ZYQ1474W7
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
unii: 8ZYQ1474W7
OASIS Tears Lubricant EyeGLYCERINOASIS Medical, Inc.00071697-4ac6-4962-8eee-388b8b52bd402025-01-22WarningsExact identifier
unii: PDC6A3C0OX
OASIS Tears Plus Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.ea931c0f-c61e-4771-84f1-0274b1c3e28e2025-01-22WarningsExact identifier
unii: PDC6A3C0OX
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
unii: 8ZYQ1474W7
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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