Home NDC 0135-0627 parodontax
Product NDC 0135-0627
11-digit product format 001350627
Labeler code 0135
Product ID 0135-0627_3dceeb8e-b90f-4f13-9b47-999695738b9b
Type HUMAN OTC DRUG
Nonproprietary name stannous fluoride
Dosage form PASTE
Route DENTAL
Labeler Haleon US Holdings LLC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-01
Substance STANNOUS FLUORIDE
Active strength 1.1 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 parodontax
Brand name suffix Complete Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416784 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 0135-0627-01 parodontaxComplete Protection 23 g in 1 TUBE PASTE 23 8 0135-0627-01 parodontaxComplete Protection 1 in 1 CARTON PASTE 1 8 0135-0627-02 parodontaxComplete Protection 96.4 g in 1 TUBE PASTE 96.4 8 0135-0627-02 parodontaxComplete Protection 1 in 1 CARTON PASTE 1 8 0135-0627-03 parodontaxComplete Protection 1 in 1 CARTON PASTE 1 8 0135-0627-03 parodontaxComplete Protection 65.2 g in 1 TUBE PASTE 65.2 8 0135-0627-04 parodontaxComplete Protection 23 g in 1 TUBE PASTE 23 8 0135-0627-05 parodontaxComplete Protection 96.4 g in 1 TUBE PASTE 96.4 8 0135-0627-05 parodontaxComplete Protection 2 in 1 CARTON PASTE 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0135-0627 PARODONTAX COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 9 package rows 20250424_59bb84d6-6fd3-4586-bccf-7dc45cbbb39c.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 25 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. edcb8451-6fa7-4bc2-95f6-2a0806f7f3da 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 576660ed-203a-4842-9d39-c5be10daf976 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 1796b3ec-833a-4cf1-ba50-bc4da827f84f 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. d923fa75-f556-45e3-9f52-39a62e89984b 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. cd3ede8c-2c77-4d81-8dff-8198025a2156 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f5f9b-4192-15e6-e053-2995a90a6457 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC 2b494372-de59-e462-e063-6294a90a08da 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City a225d515-430d-4e34-846c-0bfec3e74109 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 372f99c9-4ad3-4631-b8c8-2a34c47343cc 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 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 0135-0627-01 00135062701 1 TUBE in 1 CARTON (0135-0627-01) / 23 g in 1 TUBE 1 tube 2020-04-01 0000-00-00 No No Current 0135-0627-02 00135062702 1 TUBE in 1 CARTON (0135-0627-02) / 96.4 g in 1 TUBE 1 tube 2018-11-01 0000-00-00 No No Current 0135-0627-03 00135062703 1 TUBE in 1 CARTON (0135-0627-03) / 65.2 g in 1 TUBE 1 tube 2020-01-06 0000-00-00 No No Current 0135-0627-04 00135062704 23 g in 1 TUBE (0135-0627-04) 23 g 2022-12-01 0000-00-00 No No Current 0135-0627-05 00135062705 2 TUBE in 1 CARTON (0135-0627-05) / 96.4 g in 1 TUBE 2 tube 2025-04-01 No No Current