Home NDC 0135-0591 AQUAFRESH
Product NDC 0135-0591
11-digit product format 001350591
Labeler code 0135
Product ID 0135-0591_4af361ee-0754-8996-e063-6294a90aab2d
Type HUMAN OTC DRUG
Nonproprietary name sodium fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-09
Substance SODIUM FLUORIDE
Active strength 1.15 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 AQUAFRESH
Brand name suffix EXTRA FRESH PLUS WHITENING
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.15 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0135-0591-01 AQUAFRESHEXTRA FRESH PLUS WHITENING 1 in 1 CARTON PASTE 1 9 0135-0591-01 AQUAFRESHEXTRA FRESH PLUS WHITENING 158.8 g in 1 TUBE PASTE 158.8 9 0135-0591-02 AQUAFRESHEXTRA FRESH PLUS WHITENING 85.1 g in 1 TUBE PASTE 85.1 9 0135-0591-02 AQUAFRESHEXTRA FRESH PLUS WHITENING 1 in 1 CARTON PASTE 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0591 AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH MULTI ACTION WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 8 Current NDC, Legacy NDC, 4 package rows 20240301_5484999c-8e6f-430d-99a5-6893a2489467.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 15 of 40 · 786 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 0135-0591-01 00135059101 1 TUBE in 1 CARTON (0135-0591-01) / 158.8 g in 1 TUBE 1 tube 2016-10-01 0000-00-00 No No Current 0135-0591-02 00135059102 1 TUBE in 1 CARTON (0135-0591-02) / 85.1 g in 1 TUBE 1 tube 2016-11-01 0000-00-00 No No Current