FDA.reportPublic FDA data

United Airlines Business Class Kit

Product NDC
58733-001
11-digit product format
587330001
Labeler code
58733
Product ID
58733-001_457dd6a4-88db-dd50-e063-6294a90a5386
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
United Airlines
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-05-09
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
7.6 mg/g
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
United Airlines Business Class Kit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 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
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
94c5e9a4-19f3-4590-9da4-313c75261231Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58733-001-102021-10-15C16284748780-1ba0f9c33-4a52-a910-e053-dadaa90a0b85United Airlines Business Class Kit
58733-001-102021-01-29C16284748780-1ba0f9c33-4a52-a910-e053-dadaa90a0b85United Airlines Business Class Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58733-001-10United Airlines Business Class Kit1 in 1 PACKAGEPASTE, DENTIFRICE18
58733-001-10United Airlines Business Class Kit10 g in 1 TUBEPASTE, DENTIFRICE108

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
fluoride IonACTIVE MOIETYQ80VPU408OUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311UNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
LIMONENE, DL-INACTIVE INGREDIENT9MC3I34447UNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
SORBITOLINACTIVE INGREDIENT506T60A25RUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2
WATERINACTIVE INGREDIENT059QF0KO0RUNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58733-001UNITED AIRLINES BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [UNITED AIRLINES]7Current NDC, Legacy NDC, 2 package rows20231025_94c5e9a4-19f3-4590-9da4-313c75261231.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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN94c5e9a4-19f3-4590-9da4-313c752612318
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD94c5e9a4-19f3-4590-9da4-313c752612318
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY94c5e9a4-19f3-4590-9da4-313c752612318
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY94c5e9a4-19f3-4590-9da4-313c752612318
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY94c5e9a4-19f3-4590-9da4-313c752612318
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY94c5e9a4-19f3-4590-9da4-313c752612318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58733-001-10587330001101 TUBE in 1 PACKAGE (58733-001-10) / 10 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent