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

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
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
483d7aec-34ac-49c5-ac0e-8fba5b4737aeAvailable on FDA.report

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

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 28 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro-Health Gum Detoxify PlusSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f9e346e-d664-81d5-e063-6394a90a45252026-01-08WarningsExact identifier
application number: M021
Crest 3D White Holiday Smile Deep Stain Remover and WhitestripsSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company3c57d487-a3c7-b238-e063-6294a90aed812026-01-08Exact identifier
application number: M021
Crest Complete plus Scope Pro Advanced FreshnessSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company325c3ab2-aaa2-a06f-e063-6294a90abefb2026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5940711d-71b7-cb7d-e053-2a91aa0aef182026-01-08WarningsExact identifier
application number: M021
Meijer Restore and Defend SensitiveSTANNOUS FLUORIDEMeijer Distribution Inc82bdfdb5-39f2-8c09-e053-2991aa0a096c2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f69824-e886-6e7b-e063-6294a90acf772026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f64874-6363-3dcc-e063-6394a90a2aec2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Fresh MintSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f27a63-15f3-cee4-e063-6394a90afa3b2026-01-08WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.01f618d7-be07-18c3-e063-6294a90a2d972026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f35279-76ce-6027-e063-6294a90a8e342026-01-08WarningsExact identifier
application number: M021
Crest SnowberrySTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42ca1f06-3e7d-8fed-e063-6394a90afbff2026-01-08WarningsExact identifier
application number: M021
Crest StrawberrySODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.7d615c52-f9c9-4856-e053-2991aa0a79272026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.5a1bb1fb-12a5-5fd1-e053-2991aa0a628b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Icy Clean MintSODIUM FLUORIDEProcter & Gamble Manufacturing Mxico, S. de R.L. de C.V.8de12c9f-eb16-aa26-e053-2a95a90a1b9c2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Peppermint FrostSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company42c84772-d406-b6ca-e063-6394a90a920f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Sparkle MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company42cb1b2a-55ad-cb9c-e063-6294a90ac88c2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum RecessionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company47be4eff-1ab5-17a1-e063-6394a90ae4652026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TPSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25021787-44e8-0b29-e063-6394a90a0af62026-01-08WarningsExact identifier
application number: M021
Supersmile Professional whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502c305-71ab-bb71-e063-6394a90a0a842026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2502840c-82ee-12cb-e063-6394a90a5b3f2026-01-08WarningsExact identifier
application number: M021

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