FDA.reportPublic FDA data

equate Sensitive

Product NDC
49035-257
11-digit product format
490350257
Labeler code
49035
Product ID
49035-257_47e562a2-d35f-fddb-e063-6394a90a2717
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Wal-Mart Stores Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-02
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct49035-257IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49035-25749035-257-79IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
equate Sensitive
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal 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
79899b59-3a16-6504-e053-2991aa0a895aAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-06-265820257 Equate Sensitive Toothpaste with Fluoride
2020-06-265820257 Equate Sensitive Toothpaste with Fluoride
2020-01-315820257 Equate Sensitive Toothpaste with Fluoride
2020-01-315820257 Equate Sensitive Toothpaste with Fluoride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-257-29equate Sensitive1 in 1 CARTONPASTE, DENTIFRICE19
49035-257-29equate Sensitive2 in 1 PACKAGEPASTE, DENTIFRICE29
49035-257-79equate Sensitive1 in 1 BOXPASTE, DENTIFRICE19
49035-257-79equate Sensitive113 g in 1 TUBEPASTE, DENTIFRICE1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-257EQUATE SENSITIVE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [WAL-MART STORES INC]7Current NDC, Legacy NDC, 4 package rows20250315_79899b59-3a16-6504-e053-2991aa0a895a.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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD79899b59-3a16-6504-e053-2991aa0a895a9
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY79899b59-3a16-6504-e053-2991aa0a895a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-257-29490350257292 CARTON in 1 PACKAGE (49035-257-29) / 1 TUBE in 1 CARTON / 113 g in 1 TUBE2 carton2018-11-020000-00-00NoNoCurrent
49035-257-79490350257791 TUBE in 1 BOX (49035-257-79) / 113 g in 1 TUBE1 tube2018-11-020000-00-00NoNoCurrent