FDA.reportPublic FDA data

Business Class Kit

Product NDC
58701-002
11-digit product format
587010002
Labeler code
58701
Product ID
58701-002_45866f6a-a1fa-abc2-e063-6394a90a5e4c
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
American Airlines, Inc.
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

Additional Listing Data#

Finished product
Yes
Brand name base
Business Class Kit
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE7.6 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58701-002-10Business Class Kit10 g in 1 TUBEPASTE, DENTIFRICE1010
58701-002-10Business Class Kit1 in 1 PACKAGEPASTE, DENTIFRICE110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
fluoride IonACTIVE MOIETYQ80VPU408OBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
LIMONENE, DL-INACTIVE INGREDIENT9MC3I34447BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
SORBITOLINACTIVE INGREDIENT506T60A25RBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58701-002BUSINESS CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]9Current NDC, Legacy NDC, 2 package rows20231025_483d7aec-34ac-49c5-ac0e-8fba5b4737ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN483d7aec-34ac-49c5-ac0e-8fba5b4737ae10
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD483d7aec-34ac-49c5-ac0e-8fba5b4737ae10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY483d7aec-34ac-49c5-ac0e-8fba5b4737ae10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY483d7aec-34ac-49c5-ac0e-8fba5b4737ae10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY483d7aec-34ac-49c5-ac0e-8fba5b4737ae10
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY483d7aec-34ac-49c5-ac0e-8fba5b4737ae10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58701-002-10587010002101 TUBE in 1 PACKAGE (58701-002-10) / 10 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent