FDA.reportPublic FDA data

OralLine

Product NDC
55873-002
11-digit product format
558730002
Labeler code
55873
Product ID
55873-002_816c3b07-a6fd-4837-8260-2b6417f24fb2
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
GEL, DENTIFRICE
Route
ORAL
Labeler
J.M. Murray Center Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
SODIUM FLUORIDE
Active strength
.15 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
OralLine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c0970e9-7417-4234-89e3-3b602a609af5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55873-002-01OralLine85 g in 1 TUBEGEL, DENTIFRICE854

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
POLYETHYLENE GLYCOL 600INACTIVE INGREDIENTNL4J9F21N9ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55873-002ORALLINE SECURE (SODIUM FLUORIDE) PASTE, DENTIFRICE ORALLINE (SODIUM FLUORIDE) GEL, DENTIFRICE [J.M. MURRAY CENTER INC.]4Current NDC, Legacy NDC, 1 package rows20250322_4c0970e9-7417-4234-89e3-3b602a609af5.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN4c0970e9-7417-4234-89e3-3b602a609af54
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD4c0970e9-7417-4234-89e3-3b602a609af54
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY4c0970e9-7417-4234-89e3-3b602a609af54
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY4c0970e9-7417-4234-89e3-3b602a609af54
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY4c0970e9-7417-4234-89e3-3b602a609af54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55873-002-015587300020185 g in 1 TUBE (55873-002-01) 85 g2025-03-010000-00-00NoNoCurrent