FDA.reportPublic FDA data

SODIUM MONOFLUOROPHOSPHATE - Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd

Manufacturer
Shulisa (Foshan) Daily ChemicalIndustry Co., Ltd
Effective date
2026-04-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:35

Label at a glance#

ProductFLUORIDE ANTICAVITY,TOOTHPASTE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of child

OTC - PURPOSE SECTION

Protect teeth, maintain oral hygiene

INDICATIONS & USAGE SECTION

It is recommended to brush your teeth after each meal or at least twice a day.

WARNINGS SECTION

keep out of reach child

INACTIVE INGREDIENT SECTION

WATER,SORBITOL,HYDRATED SILICA,GLYCERIN,PEG-32,SODIUM LAURYL SULFATE,CELLULOSE GUM,SODIUM SACCHARIN,EUCALYPTUS GLOBULUS LEAF OIL,METHYL SALICYLATE,THYMOL,PHOSPHORIC ACID,MENTHOLUM,Tetrasodium Pyrophosphate,XANTHAN GUM,SODIUM BENZOATE,Fragrance,Spearmint Leaf Oil,Disodium Hydrogen Phosphate,CARBON BLACK,IRON OXIDES

DOSAGE & ADMINISTRATION SECTION

It is recommended to brush your teeth after each meal or at least twice a day.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87576-332-02FLUORIDE ANTICAVITY,TOOTHPASTE1 in 1 BOXPASTE, DENTIFRICE11
87576-332-02FLUORIDE ANTICAVITY,TOOTHPASTE1 in 1 TUBEPASTE, DENTIFRICE11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87576-33287576-332-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
PEG-321212Z7S33AIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
THYMOL3J50XA376EIACT
MENTHOLL7T10EIP3AIACT
SODIUM BENZOATEOJ245FE5EUIACT
CELLULOSE GUMK679OBS311IACT
SODIUM SACCHARINSB8ZUX40TYIACT
CARBON BLACK4XYU5U00C4IACT
FERRIC OXIDE RED1K09F3G675IACT
GLYCERINPDC6A3C0OXIACT
METHYL SALICYLATELAV5U5022YIACT
XANTHAN GUMTTV12P4NEEIACT
PHOSPHORIC ACID P-32N9H3ZTX0BGIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
FRAGRANCE 135765EM498GW35IACT
TETRASODIUM PYROPHOSPHATEO352864B8ZIACT
SPEARMINT OILC3M81465G5IACT
DISODIUM HYDROGEN CITRATE6FO62KCQ7AIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FLUORIDE ANTICAVITY,TOOTHPASTEFLUORIDE ANTICAVITY TOOTHPASTEShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e912f10-64f2-d179-e063-6294a90a748d2026-04-03WarningsExact identifier
ndc (package): 87576-332-02
ndc (product): 87576-332
ndc11 (package): 87576033202
spl id: 4e912f10-64f3-d179-e063-6294a90a748d
spl set id: 4e912f10-64f2-d179-e063-6294a90a748d

Reported adverse events (FAERS/openFDA)#

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