First Class Kit

Product NDC
58701-001
11-digit product format
587010001
Labeler code
58701
Product ID
58701-001_457da70c-ba2e-468b-e063-6394a90a276a
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
First 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
ba717de8-c3a2-41bf-85a1-aa75f9744d30Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58701-001-10First Class Kit1 in 1 PACKAGEPASTE, DENTIFRICE110
58701-001-10First Class Kit10 g in 1 TUBEPASTE, DENTIFRICE1010

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58701-001FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.]9Current NDC, Legacy NDC, 2 package rows20231025_ba717de8-c3a2-41bf-85a1-aa75f9744d30.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 41 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8f27c88a-7a70-e00a-e053-2a95a90a95a42025-01-01WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDETAI GUK PHARM. CO., LTD0abb7a95-60b1-a1f3-e063-6294a90ace0c2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.99fff177-6300-220e-e053-2a95a90a06602025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
application number: M021
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
application number: M021
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05aafc53-49ca-eacd-e063-6394a90a606b2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b18bb6-9fbf-469b-e063-6294a90a4f2f2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.9c820740-9148-3a9c-e053-2a95a90a39682025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials Fresh Aloe Green MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.a3b21ceb-5aa5-29b4-e053-2a95a90a95452025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNba717de8-c3a2-41bf-85a1-aa75f9744d3010
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDba717de8-c3a2-41bf-85a1-aa75f9744d3010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYba717de8-c3a2-41bf-85a1-aa75f9744d3010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYba717de8-c3a2-41bf-85a1-aa75f9744d3010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYba717de8-c3a2-41bf-85a1-aa75f9744d3010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYba717de8-c3a2-41bf-85a1-aa75f9744d3010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58701-001-10587010001101 TUBE in 1 PACKAGE (58701-001-10) / 10 g in 1 TUBE1 tube2013-05-090000-00-00NoNoCurrent