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 34 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Whipped Mellow Mint Dream FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company7a72b687-475d-437a-9734-a29637e5516a2025-11-11WarningsExact identifier
application number: M021
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
application number: M021
Hello Naturally WhiteningSODIUM MONOFLUOROPHOSPHATECOLGATE PALMOLIVE COMPANY5ad241e1-6bfc-7863-6a7a-100753651f0a2025-11-11WarningsExact identifier
application number: M021
Hello Whipped Peppermint Stick FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyd6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f8132025-11-11WarningsExact identifier
application number: M021
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact 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