Home NDC 58701-001 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 Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 7.6 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58701-001-10 First Class Kit 1 in 1 PACKAGE PASTE, DENTIFRICE 1 10 58701-001-10 First Class Kit 10 g in 1 TUBE PASTE, DENTIFRICE 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Monofluorophosphate ACTIVE INGREDIENT C810JCZ56Q FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 fluoride Ion ACTIVE MOIETY Q80VPU408O FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 LIMONENE, DL- INACTIVE INGREDIENT 9MC3I34447 FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 SODIUM PYROPHOSPHATE INACTIVE INGREDIENT O352864B8Z FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58701-001 FIRST CLASS KIT (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [AMERICAN AIRLINES, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20231025_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 38 of 49 · 974 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58701-001-10 58701000110 1 TUBE in 1 PACKAGE (58701-001-10) / 10 g in 1 TUBE 1 tube 2013-05-09 0000-00-00 No No Current