FDA.reportPublic FDA data

Made by Dentists Enamel Rebuilding Fresh Mint

Product NDC
75065-028
11-digit product format
750650028
Labeler code
75065
Product ID
75065-028_5cca02bf-3e6f-f530-e063-6294a90a0a41
Type
HUMAN OTC DRUG
Nonproprietary name
POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form
PASTE
Route
DENTAL
Labeler
MADE BY DENTISTS INC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-22
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.5 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
Made by Dentists Enamel Rebuilding Fresh Mint
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.5 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75065-028-06Made by Dentists Enamel Rebuilding Fresh Mint120 g in 1 TUBEPASTE1201
75065-028-06Made by Dentists Enamel Rebuilding Fresh Mint1 in 1 CARTONPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75065-028MADE BY DENTISTS ENAMEL REBUILDING FRESH MINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [MADE BY DENTISTS INC]1Current NDC, 2 package rows20240229_a9260baf-46c8-40cb-a6c3-7aedb086c870.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 % ToothpastePSNa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYa9260baf-46c8-40cb-a6c3-7aedb086c8701
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYa9260baf-46c8-40cb-a6c3-7aedb086c8701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75065-028-06750650028061 TUBE in 1 CARTON (75065-028-06) / 120 g in 1 TUBE1 tube2024-02-22NoNoCurrent