Home NDC 54897-701 Salivea
Product NDC 54897-701
11-digit product format 548970701
Labeler code 54897
Product ID 54897-701_2b37e5f3-ae54-4993-e063-6394a90aff97
Type HUMAN OTC DRUG
Nonproprietary name Fluoride Toothpaste
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Laclede, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-19
Substance SODIUM MONOFLUOROPHOSPHATE
Active strength 1.4 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 Salivea
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1.4 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 851054 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 54897-701-13 Salivea 121.9 g in 1 TUBE PASTE, DENTIFRICE 121.9 3 54897-701-14 Salivea 21 g in 1 TUBE PASTE, DENTIFRICE 21 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54897-701 SALIVEA (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [LACLEDE, INC.] 3 Current NDC, 1 package rows 20250110_6398ae96-dd38-44da-bc34-1d4d4c4a78ca.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 5 of 51 · 1,013 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 54897-701-13 54897070113 121.9 g in 1 TUBE (54897-701-13) 121.9 g 2018-02-19 No No Current 54897-701-14 54897070114 21 g in 1 TUBE (54897-701-14) 21 g 2025-01-01 Yes No Current