FDA.reportPublic FDA data

Signature Care Sensitive

Product NDC
21130-351
11-digit product format
211300351
Labeler code
21130
Product ID
21130-351_43956f49-90bd-5b18-e063-6294a90aad71
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Safeway
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-02
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
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
Signature Care Sensitive
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.15 g/100g
POTASSIUM NITRATE5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
83225fe5-0490-eb4b-e053-2a91aa0a6879Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-351-19Signature Care SensitiveMaximum Strength113 g in 1 TUBEPASTE, DENTIFRICE11315
21130-351-19Signature Care SensitiveMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE115
21130-351-20Signature Care SensitiveMaximum Strength2 in 1 PACKAGEPASTE, DENTIFRICE215
21130-351-20Signature Care SensitiveMaximum Strength1 in 1 CARTONPASTE, DENTIFRICE115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-351SIGNATURE CARE SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [SAFEWAY]13Current NDC, Legacy NDC, 4 package rows20250123_83225fe5-0490-eb4b-e053-2a91aa0a6879.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY83225fe5-0490-eb4b-e053-2a91aa0a687915
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY83225fe5-0490-eb4b-e053-2a91aa0a687915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-351-19211300351191 TUBE in 1 CARTON (21130-351-19) / 113 g in 1 TUBE1 tube2019-03-020000-00-00NoNoCurrent
21130-351-20211300351202 CARTON in 1 PACKAGE (21130-351-20) / 1 TUBE in 1 CARTON / 113 g in 1 TUBE2 carton2019-03-020000-00-00NoNoCurrent