Home NDC 0135-0486-01 SENSODYNE PRONAMEL
Product NDC 0135-0486
Requested package NDC 0135-0486-01
11-digit product format 001350486
Labeler code 0135
Product ID 0135-0486_4c9ab9d6-fc06-eea3-e063-6394a90a5939
Type HUMAN OTC DRUG
Nonproprietary name potassium nitrate and sodium fluoride
Dosage form PASTE
Route ORAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-29
Substance POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength 50; 1.15 mg/g; 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 SENSODYNE PRONAMEL
Brand name suffix Intensive Enamel Repair Extra Fresh
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM NITRATE 50 mg/g SODIUM FLUORIDE 1.15 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1086243 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 0135-0486-01 SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh 1 in 1 CARTON PASTE 1 10 0135-0486-01 SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh 96.4 g in 1 TUBE PASTE 96.4 10 0135-0486-02 SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh 2 in 1 CARTON PASTE 2 10 0135-0486-02 SENSODYNE PRONAMELIntensive Enamel Repair Extra Fresh 96.4 g in 1 TUBE PASTE 96.4 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0486 SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 9 Current NDC, Legacy NDC, 4 package rows 20240410_a2f9d58b-671b-4427-a971-1fceff5f2323.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 7 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lemon Glycerin GLYCERIN Dynarex Corporation 99fc00ea-9d55-0380-e053-2995a90a2c0b 2026-03-24 Warnings Exact identifier application number: M022 Dual-FormulaToothpaste for sensitive teeth DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH Hangzhou Namei Zhikang Technology Co., Ltd. 4d735f91-8abc-3a30-e063-6394a90a7639 2026-03-20 Warnings Exact identifier application number: M022 SmileCare Mouth Ulcer Gel MENTHOL Yantai Aien Biotechnology Co., Ltd. 4d6db039-5b97-8f3f-e063-6294a90a9d85 2026-03-19 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f91e609-8ca5-0492-e053-2a95a90a85d0 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f81ffa5-05fd-4eef-e053-2995a90aac3e 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f947366-9380-3fa9-e053-2a95a90ad49c 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f947672-4873-5546-e053-2a95a90a3c4b 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f9490c1-8bfe-3166-e053-2a95a90a7175 2026-03-17 Warnings Exact identifier application number: M022 Quala Topical Anesthetic Gel BENZOCAINE National Distribution & Contracting, Inc 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 2026-03-17 Warnings Exact identifier application number: M022 BencoCaine Topical Anesthetic BENZOCAINE Benco Dental 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b 2026-03-17 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic BENZOCAINE Beutlich Pharmaceuticals, LLC 043c00a6-1346-7780-e063-6294a90a3d5a 2026-03-12 Warnings Exact identifier application number: M022 ORAL PAIN RELIEF BENZOCAINE Nantong Health & Beyond Hygienic Products Inc. a5f0be98-d47e-4307-8044-304a64db774b 2026-03-11 Warnings Exact identifier application number: M022 SENSODYNE PRONAMEL Intensive Enamel Repair Whitening POTASSIUM NITRATE AND SODIUM FLUORIDE Haleon US Holdings LLC a2f9d58b-671b-4427-a971-1fceff5f2323 2026-03-09 Warnings Exact identifier application number: M022 ndc (package): 0135-0486-01 ndc (product): 0135-0486 ndc11 (package): 00135048601 Sore Mouth Cleanser HYDROGEN PEROXIDE CVS Pharmacy, Inc. a5dbaadf-76a8-4c48-af2d-f4455e9411f0 2026-03-09 Warnings, Adverse reactions Exact identifier application number: M022 Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Sam's West, Inc 78a3e024-73da-40b7-9d9c-099fd6ca9b9e 2026-03-03 Warnings Exact identifier application number: M022 Sore Throat PHENOL GLYCERIN CVS PHARMACY, INC 9683bcfb-2f7e-48a4-aa79-500ee8df099a 2026-03-02 Warnings Exact identifier application number: M022 Spring Gene Oil Pulling Sensitivity POTASSIUM NITRATE Health and Natural Beauty USA Corp 294051e3-69ec-4190-8b03-fa34988376b7 2026-02-26 Warnings Exact identifier application number: M022 Lolleez Watermelon PECTIN BFY LLC 4ba8af8b-5a17-8b8c-e063-6394a90a63f3 2026-02-25 Warnings Exact identifier application number: M022 Oral Sore Antiseptic HYDROGEN PEROXIDE, MENTHOL H E B f1450866-1be4-46d9-9fe4-52d699636b4f 2026-02-24 Warnings, Adverse reactions Exact identifier application number: M022 SIGNATURE CARE SORE THROAT CHERRY FLAVOR PHENOL SAFEWAY 94a2c1b9-f462-4489-b84a-825a82835d30 2026-02-23 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 0135-0486-01 00135048601 1 TUBE in 1 CARTON (0135-0486-01) / 96.4 g in 1 TUBE 1 tube 2018-11-29 0000-00-00 No No Current