FDA.reportPublic FDA data

PLAK SMACKER Anti-cavity Fluoride Gel

Manufacturer
HUAIAN ZONGHENG BIO-TECH CO., LTD
Effective date
2018-03-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:54:53

Label at a glance#

ProductPLAK SMACKER Anti-cavity Fluoride Gel
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children as necessary until capable of using without supervision

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride 0.24%（0.14% w/v fluoride ion）

Purpose

OTC - PURPOSE SECTION

Anticavitytoothpaste

Use

INDICATIONS & USAGE SECTION

helps aid in the prevention of dental cavities.

Warning

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidently swallowed get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:brush teeth thoroughly, after meals or at least twice a day or use as directed by a dentist.

do not swallow

to minimize swallowing use a pea-sized amount in children under 6

supervise children as necessary until capable of using without supervision

Inactive Ingredients

INACTIVE INGREDIENT SECTION

sorbitl,water,silicon dioxide,glycerin,saccharin sodium,PEG-8,sodium carboxymethyl cellulose ,lauryl sodium sulfate,aroma,sodium benzoate,ci42090anium Dioxide),Sodium saccharin,rose canina fruit oil

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71167-005-012020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-022020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-032020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-042020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-052020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-062020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-072020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-082020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-092020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-102020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-112020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-122020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24
71167-005-132020-01-31C16284748780-19d75b9d0-9622-f424-e053-dadaa90a57ce71167-005 PLAK SMACKER 0.24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71167-005-01PLAK SMACKER Anti-cavity Fluoride Gel144 in 1 CARTONPASTE1442
71167-005-01PLAK SMACKER Anti-cavity Fluoride Gel24 g in 1 TUBEPASTE242
71167-005-02PLAK SMACKER Anti-cavity Fluoride Gel120 in 1 CARTONPASTE1202
71167-005-02PLAK SMACKER Anti-cavity Fluoride Gel24 in 1 BOXPASTE242
71167-005-03PLAK SMACKER Anti-cavity Fluoride Gel24 in 1 BOXPASTE242
71167-005-03PLAK SMACKER Anti-cavity Fluoride Gel120 in 1 CARTONPASTE1202
71167-005-04PLAK SMACKER Anti-cavity Fluoride Gel144 in 1 CARTONPASTE1442
71167-005-04PLAK SMACKER Anti-cavity Fluoride Gel50 g in 1 TUBEPASTE502
71167-005-05PLAK SMACKER Anti-cavity Fluoride Gel100 g in 1 TUBEPASTE1002
71167-005-05PLAK SMACKER Anti-cavity Fluoride Gel72 in 1 CARTONPASTE722
71167-005-06PLAK SMACKER Anti-cavity Fluoride Gel144 in 1 BOXPASTE1442
71167-005-06PLAK SMACKER Anti-cavity Fluoride Gel100 g in 1 TUBEPASTE1002
71167-005-07PLAK SMACKER Anti-cavity Fluoride Gel28 g in 1 TUBEPASTE282
71167-005-07PLAK SMACKER Anti-cavity Fluoride Gel480 in 1 BOXPASTE4802
71167-005-08PLAK SMACKER Anti-cavity Fluoride Gel120 g in 1 TUBEPASTE1202
71167-005-08PLAK SMACKER Anti-cavity Fluoride Gel72 in 1 BOXPASTE722
71167-005-09PLAK SMACKER Anti-cavity Fluoride Gel120 g in 1 TUBEPASTE1202
71167-005-09PLAK SMACKER Anti-cavity Fluoride Gel144 in 1 BOXPASTE1442
71167-005-10PLAK SMACKER Anti-cavity Fluoride Gel50 g in 1 TUBEPASTE502
71167-005-10PLAK SMACKER Anti-cavity Fluoride Gel288 in 1 BOXPASTE2882
71167-005-11PLAK SMACKER Anti-cavity Fluoride Gel480 in 1 CARTONPASTE4802
71167-005-11PLAK SMACKER Anti-cavity Fluoride Gel24 in 1 BOXPASTE242
71167-005-12PLAK SMACKER Anti-cavity Fluoride Gel576 in 1 CARTONPASTE5762
71167-005-12PLAK SMACKER Anti-cavity Fluoride Gel144 in 1 BOXPASTE1442
71167-005-13PLAK SMACKER Anti-cavity Fluoride Gel72 in 1 CARTONPASTE722
71167-005-13PLAK SMACKER Anti-cavity Fluoride Gel12 in 1 BOXPASTE122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71167-005PLAK SMACKER ANTI-CAVITY FLUORIDE GEL (SODIUM FLUORIDE) PASTE [HUAIAN ZONGHENG BIO-TECH CO., LTD]2Legacy NDC, 26 package rows20180314_6657b534-f79a-0407-e053-2a91aa0a0f45.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71167-00571167-005-01, 71167-005-02, 71167-005-04, 71167-005-05, 71167-005-06, 71167-005-03, 71167-005-07, 71167-005-08, 71167-005-09, 71167-005-10, 71167-005-11, 71167-005-12, 71167-005-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL, L-01Q0586BG1IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
PEG-8 DIOLEATE6JR5A7273EIACT
DISODIUM CARBOXYMETHYLARSONATET9HTL93NB7IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
AROMADENDRIN7YA4640575IACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
675d324a-a218-fae2-e053-2a91aa0a6b806657b534-f79a-0407-e053-2a91aa0a0f452018-03-14WarningsExact identifier
spl id: 675d324a-a218-fae2-e053-2a91aa0a6b80
spl set id: 6657b534-f79a-0407-e053-2a91aa0a0f45

Reported adverse events (FAERS/openFDA)#

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