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 73 of 79 · 1,564 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natrum FluoratumNATRUM FLUORATUMHahnemann Laboratories, INC.e54bdb28-890b-4869-e053-2995a90a8efd2022-08-02Exact identifier
unii: 8ZYQ1474W7
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
unii: K679OBS311
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Iris 60 Second APFSODIUM FLUORIDEBenco Dental5fa57e34-5827-4d37-a5dc-965750e5be502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental6a0f889d-5f27-496f-b830-d778ee867ade2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dental8f5d420b-3348-4002-9a09-b05e8cbb35c92022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentalc93f67f5-9833-4a7a-a67a-49a51843e68d2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Iris 60 Second APFSODIUM FLUORIDEBenco Dentald5658bf8-3a13-4d8b-b727-5f15759195712022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inca7259222-4ee1-42b2-8beb-3f29a5eb29092022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
Burkhart Neutral pHSODIUM FLUORIDEBurkhart Dental Supply Inc0fb4d584-36e8-4db7-b72e-04608580dacd2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc2531ad94-b229-4212-a7a3-f793567a06b62022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc804e7850-1952-4e86-804e-d800ee6e7b502022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc87b3b8b8-780f-492d-bd75-b005edd55baa2022-02-02WarningsExact identifier
unii: 8ZYQ1474W7
BurkhartSODIUM FLUORIDEBurkhart Dental Supply Inc79fa0a42-bb69-49db-9997-1679a75bac262022-02-02WarningsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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