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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact 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