FDA.reportPublic FDA data

NDC 44038-0326 - 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
44038-0326
Package NDCs from labels
44038-0326-1
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
44038-0326HISMILE (SODIUM FLUORIDE) GEL [ACCUPAC LLC]2Unmatched20240921_2279d5a8-8ee4-4e81-e063-6394a90afb9c.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 16 of 79 · 1,564 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
unii: 8ZYQ1474W7
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
unii: 8ZYQ1474W7
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
FleetGLYCERINC.B. Fleet Company, Inc.31778652-e60e-4098-8e90-3e4f56b5800c2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd4c6094b7-c1ef-26a3-e063-6394a90af4cc2026-03-06WarningsExact identifier
unii: PDC6A3C0OX
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCbb451b22-c4f6-291d-e053-2a95a90a78012026-03-06WarningsExact identifier
unii: K679OBS311
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral RinseSODIUM FLUORIDEAMD Medicom1da64824-9389-4109-bea9-b91600caf0232026-03-05WarningsExact identifier
unii: 8ZYQ1474W7
PCXX VANILLA ORANGE ONE MINUTE FMSODIUM FLUORIDERoss Healthcare Inc.5e816186-519e-606e-e053-2a91aa0a34602026-03-05Exact identifier
unii: 8ZYQ1474W7
PCXX STRAWBERRY APF FSODIUM FLUORIDERoss Healthcare Inc.5e859333-b798-2dd3-e053-2991aa0af2e32026-03-05Exact identifier
unii: 8ZYQ1474W7
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
unii: 8ZYQ1474W7
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PCXX PEPPERMINT NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.8287b2de-0289-3eaa-e053-2a91aa0a0bd32026-03-02Exact identifier
unii: 8ZYQ1474W7
PCXX WATERMELON APF GSODIUM FLUORIDERoss Healthcare Inc.8287b2de-028a-3eaa-e053-2a91aa0a0bd32026-03-02Exact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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