Home NDC 0135-0591-01 AQUAFRESH
Product NDC 0135-0591
Requested package NDC 0135-0591-01
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 30 of 40 · 782 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Benzo-Jel BENZOCAINE Henry Schein Inc. bc2e7ac3-f9e4-49cc-9f0c-6fe94479314d 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. fb38b10d-0faf-403c-9921-d4f6b0f6aa55 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. a9dc2245-c029-4453-bfc5-8fb899873c34 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. ba49a18d-8568-421b-a495-8fee863c9757 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. c9b584d9-7407-445a-b084-926250af9f8e 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 4aa6eec8-394a-4ecb-8173-66561fd64913 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 25c99ae3-90f4-4a63-924d-f810b3ba6e60 2025-01-03 Warnings Exact identifier application number: M022 Benzo-Jel BENZOCAINE Henry Schein Inc. 84e8d5c8-2a35-4179-9a9c-9a4a52c2cae6 2025-01-03 Warnings Exact identifier application number: M022 Prevention Oncology Mouth Rinse GLYCERIN Prevention Health Sciences, Inc. 1ec9ed1c-bcb6-3a0a-e054-00144ff8d46c 2025-01-01 Warnings Exact identifier application number: M022 Prevention Mouth Sore Rinse HYDROGEN PEROXIDE Prevention Health Sciences, Inc. 2eae61e4-1800-5fa6-e063-6394a90a9583 2025-01-01 Warnings Exact identifier application number: M022 Antiseptic Lil Drug Store Products EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL Lil' Drug Store Products, Inc dca36a30-2c9f-4d0b-be88-b45c7046f509 2024-12-31 Warnings Exact identifier application number: M022 Sensodyne Clinical White Intensive Clean POTASSIUM NITRATE, SODIUM FLUORIDE Haleon US Holdings LLC f193ec40-032f-42c7-81f1-029ec8989374 2024-12-31 Warnings Exact identifier application number: M022 TeethWhitening Kit TEETHWHITENING KIT Jiangxi Dentalbright Technology Co., Ltd. 29393313-217a-dc3a-e063-6294a90addb1 2024-12-20 Warnings Exact identifier application number: M022 Breezers Cool Berry PECTIN Mondelez Global LLC b31d0078-21d7-4d18-a8d3-7c8d48d6d004 2024-12-20 Warnings Exact identifier application number: M022 Breezers Creamy Strawberry PECTIN Mondelez Global LLC 777fd6db-f129-4489-8312-4b1aca94878e 2024-12-20 Warnings Exact identifier application number: M022 Halls Breezers Sugar Free Cool Berry PECTIN Mondelez Global LLC dd1b4b17-4f73-4052-9589-d5fd6bb059bb 2024-12-20 Warnings Exact identifier application number: M022 Oral Gel Oral Pain Relief BENZOCAINE BENZALKONIUM CHLORIDE Savvy Care and Cosmetics 05ede7e4-5a0a-c942-e063-6294a90a8a24 2024-12-19 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Sparkling Clean Mint SODIUM BICARBONATE Lotus Brands, Inc. 4a95c8c1-db7c-4791-ac58-3eac216a0126 2024-12-18 Warnings Exact identifier application number: M022 EcoDent Ultimate Essential Mouthcare Spicy-Cool Cinnamon SODIUM BICARBONATE Lotus Brands, Inc. 6703b29d-cdc9-4c74-91c0-fb0c98dd043e 2024-12-18 Warnings Exact identifier application number: M022 Red Cross Oral Pain Relief BENZOCAINE The Mentholatum Company cbd41429-f730-4577-9f06-ef1831cf62e1 2024-12-17 Warnings Exact identifier application number: M022
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