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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Clean Breath PeppermintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ef07b-ee68-e6ae-e063-6394a90af5e52026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsExact identifier
application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4146d-6281-fe66-e063-6394a90a32c32026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef5261e-9d2f-ae05-e063-6294a90a489a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening UpkeepSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0876d9-41c9-d891-e063-6394a90a1cbd2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef57a05-b9f5-42f7-e063-6294a90a5d892026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ee26a82-16fd-f0fb-e063-6394a90a91d12026-04-09WarningsExact identifier
application number: M021
Crest 3D White Whitening Therapy Deep Clean CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company812c1519-1a4b-2495-e053-2a91aa0a914a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4e7c2-1f58-59fc-e063-6294a90ad43b2026-04-08WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited4ef669b9-defe-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c89efc-5fa0-2a05-e053-2a95a90a7b9c2026-04-07WarningsExact identifier
application number: M021
Crest 3D White Advanced CharcoalSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4eb8111-53da-17ae-e053-2a95a90a11272026-04-07WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLC35385ada-bd8d-4d38-9587-0256885f749f2026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLCcf0c8b48-0d1c-406a-a67d-7d16187d38d82026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Arctic FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfa08a877-b9e5-4eba-b832-3a28f4f3f83c2026-04-07WarningsExact identifier
application number: M021
Anticavity FluorideSODIUM FLUORIDEFamily Dollar (FAMILY WELLNESS)63c4c0e9-84b1-4076-bdf4-7e9543b2cf462026-04-01WarningsExact identifier
application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.98a8cee8-9f3c-4a4a-89f8-72e1f1b067962026-04-01WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsExact 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