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
IngredientStrength
STANNOUS FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
59bb84d6-6fd3-4586-bccf-7dc45cbbb39cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0627-01parodontaxComplete Protection23 g in 1 TUBEPASTE238
0135-0627-01parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-02parodontaxComplete Protection96.4 g in 1 TUBEPASTE96.48
0135-0627-02parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-03parodontaxComplete Protection1 in 1 CARTONPASTE18
0135-0627-03parodontaxComplete Protection65.2 g in 1 TUBEPASTE65.28
0135-0627-04parodontaxComplete Protection23 g in 1 TUBEPASTE238
0135-0627-05parodontaxComplete Protection96.4 g in 1 TUBEPASTE96.48
0135-0627-05parodontaxComplete Protection2 in 1 CARTONPASTE28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0627-02GM - Gram0135-06275976a5b6-ebee-4cfa-8b5d-b4fca28d74cf12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0627PARODONTAX COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 9 package rows20250424_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 14 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
application number: M022
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
application number: M022
HEB Extra WhiteningFLUORIDEHEB9bdcbd3f-095b-43d1-8a8e-0ba3eab14e0e2025-11-21WarningsExact identifier
application number: M022
HEB Enamel Protection Multi ActionPOTASSIUM NITRATE, SODIUM FLUORIDEHEB8255de83-aa60-b081-e053-2a91aa0afcdc2025-11-21WarningsExact identifier
application number: M022
CVS Enamel GuardFLUORIDECVS Pharmacyd9dfa515-426b-9059-e053-2a95a90a38852025-11-21WarningsExact identifier
application number: M022
CVS Extra WhiteningFLUORIDECVS Pharmacy3b019849-6585-4a8c-a90a-c7e9e617b3ef2025-11-21WarningsExact identifier
application number: M022
DG 4x Medicated Tooth and Gum CreamBENZOCAINEDollar Generalb2c156f0-6d11-1eba-e053-2995a90a6db82025-11-21WarningsExact identifier
application number: M022
4x Medicated Toothache and Gum GelBENZOCAINECVSa7577d5f-69cf-3f32-e053-2995a90aaba52025-11-21WarningsExact identifier
application number: M022
Rite Aid Professional StrengthBENZOCAINERite Aid31ce0cb3-a43a-41bd-b030-21f91f2b13682025-11-21WarningsExact identifier
application number: M022
Rite Aid Maximum StrengthBENZOCAINERite Aid5e216587-5384-464a-a4dd-07943668cabd2025-11-21WarningsExact identifier
application number: M022
Walgreens Sensitive Extra WhiteningSODIUM FLUORIDEWalgreense807b8a0-6d58-a15f-e053-2995a90a2ea12025-11-21WarningsExact identifier
application number: M022
NBE AnbesolBENZOCAINEWalgreensdd2a3125-32f8-5fff-e053-2995a90ac7202025-11-21WarningsExact identifier
application number: M022
Walgreens Maximum StrengthBENZOCAINEWalgreens2ef0eb2c-b614-44e2-b9b3-97b02c6549772025-11-21WarningsExact identifier
application number: M022
Toothache and Gum Relief CushionsBENZOCAINERite Aid9970d485-0b78-1438-e053-2995a90ad32c2025-11-21WarningsExact identifier
application number: M022
Pronamel Repair WhiteningFLUORIDERite Aid21645dd5-5cb7-2088-e063-6394a90a61ff2025-11-21WarningsExact identifier
application number: M022
Throat Coat Lemon Ginger EchinaceaPECTINTraditional Medicinals, Inc.a7a92a52-9ace-66d1-e053-2a95a90a8d8e2025-11-21WarningsExact identifier
application number: M022
GumsolBENZOCAINE, ZINC CHLORIDEKramer Novis3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf2025-11-15WarningsExact identifier
application number: M022
3x Medicated Toothache and Gum GelBENZOCAINECVSa75788ef-8ccc-7e6a-e053-2a95a90a1aeb2025-11-14WarningsExact identifier
application number: M022
Signature Care Enamel Guard Sensitive Gentle WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDESafeway83222361-b89d-90e7-e053-2991aa0a75792025-11-14WarningsExact identifier
application number: M022
DG 3x Medicated Toothache adn Gum GelBENZOCAINEDollar Generalb2c0e442-4cba-589d-e053-2995a90a6bca2025-11-14WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY59bb84d6-6fd3-4586-bccf-7dc45cbbb39c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0627-01001350627011 TUBE in 1 CARTON (0135-0627-01) / 23 g in 1 TUBE1 tube2020-04-010000-00-00NoNoCurrent
0135-0627-02001350627021 TUBE in 1 CARTON (0135-0627-02) / 96.4 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
0135-0627-03001350627031 TUBE in 1 CARTON (0135-0627-03) / 65.2 g in 1 TUBE1 tube2020-01-060000-00-00NoNoCurrent
0135-0627-040013506270423 g in 1 TUBE (0135-0627-04) 23 g2022-12-010000-00-00NoNoCurrent
0135-0627-05001350627052 TUBE in 1 CARTON (0135-0627-05) / 96.4 g in 1 TUBE2 tube2025-04-01NoNoCurrent