FDA.reportPublic FDA data

Salivea

Product NDC
54897-701
11-digit product format
548970701
Labeler code
54897
Product ID
54897-701_2b37e5f3-ae54-4993-e063-6394a90aff97
Type
HUMAN OTC DRUG
Nonproprietary name
Fluoride Toothpaste
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Laclede, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-19
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.4 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Salivea
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
851054Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6398ae96-dd38-44da-bc34-1d4d4c4a78caAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54897-701-13Salivea121.9 g in 1 TUBEPASTE, DENTIFRICE121.93
54897-701-14Salivea21 g in 1 TUBEPASTE, DENTIFRICE211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54897-701SALIVEA (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [LACLEDE, INC.]3Current NDC, 1 package rows20250110_6398ae96-dd38-44da-bc34-1d4d4c4a78ca.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 47 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
application number: M021
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
application number: M021
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
application number: M021
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
application number: M021
Barbie Bubble Gum ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.dc5489e9-eeff-4db5-8793-21fb5bf4b2ef2024-05-10WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
application number: M021
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
application number: M021
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
application number: M021
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
application number: M021
DeCureSODIUM MONOFLUOROPHOSPHATEScope medical devices private limited590c4827-f036-45bd-af30-0a4853ca34472024-05-07WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
application number: M021
Toothpaste, plus ToothbrushSODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSHLil' Drug Store Products, Inc.15ac00f8-da51-6cea-e063-6294a90aeb812024-04-09WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company142bffe1-1e8c-8567-e063-6394a90af15a2024-03-21WarningsExact identifier
application number: M021
Made by Dentists Ultra Whitening Fresh MintSODIUM FLUORIDEMADE BY DENTISTS INCdbce2aba-48db-4e78-bf79-74f34868ee372024-03-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.13907bf6-9a95-c0b2-e063-6394a90a40422024-03-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
851054sodium monofluorophosphate 0.14 % ToothpastePSN6398ae96-dd38-44da-bc34-1d4d4c4a78ca3
851054sodium monofluorophosphate 0.0014 MG/MG ToothpasteSCD6398ae96-dd38-44da-bc34-1d4d4c4a78ca3
851054sodium monofluorophosphate 0.14 % Dental GelSY6398ae96-dd38-44da-bc34-1d4d4c4a78ca3
851054sodium monofluorophosphate 0.14 % ToothpasteSY6398ae96-dd38-44da-bc34-1d4d4c4a78ca3
851054sodium monofluorophosphate 0.14 % ToothpastePSN4abb0f80-d87d-730f-e063-6294a90a15f71
851054sodium monofluorophosphate 0.0014 MG/MG ToothpasteSCD4abb0f80-d87d-730f-e063-6294a90a15f71
851054sodium monofluorophosphate 0.14 % Dental GelSY4abb0f80-d87d-730f-e063-6294a90a15f71
851054sodium monofluorophosphate 0.14 % ToothpasteSY4abb0f80-d87d-730f-e063-6294a90a15f71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54897-701-1354897070113121.9 g in 1 TUBE (54897-701-13) 121.9 g2018-02-19NoNoCurrent
54897-701-145489707011421 g in 1 TUBE (54897-701-14) 21 g2025-01-01YesNoCurrent