FDA.reportPublic FDA data

Made by Dentists Enamel 10 Fluoride Anticavity

Product NDC
75065-033
11-digit product format
750650033
Labeler code
75065
Product ID
75065-033_5b9b278a-8dab-1f6b-e063-6394a90a788b
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
2026-08-01
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 10 Fluoride Anticavity
Listing expiration
2027-12-31

Active Ingredients#

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

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 22 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWinCo Foods, LLC9417b340-942b-48bf-bbfd-4cd5154082b92025-02-12WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCb291811f-8fac-45e2-a9a2-b3ecc0813d0d2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCfea30599-5e3b-4163-9660-d41b3fcee1432025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC3be68966-199c-481e-8b9e-e994c41fd96a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCccdee0cc-2bc9-4165-a411-02f4f900d86a2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b72025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC69c4dd1b-a0db-4495-bfc3-faffdfdf59bf2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLCd5ef3e65-35e8-4323-9f33-3076b561e1052025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC746df21c-e92e-4a71-b1c6-baf99785a43e2025-01-29WarningsExact identifier
application number: M022
NRG Topical AnestheticBENZOCAINEIQ Dental Supply, LLC2345e614-c7b6-448c-8e07-31700bade91c2025-01-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Belport Company, Inc. DBA Gingi-Pak142062ca-6f8f-78d2-e063-6294a90a19d82025-01-29Warnings, Adverse reactionsExact identifier
application number: M022
CHLORASEPTIC MAXMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.edd12a2d-aa27-4f15-9ce6-862e4b6144c42025-01-23WarningsExact identifier
application number: M022
meijer Sensitive FRESH MINTPOTASSIUM NITRATE, SODIUM FLUORIDEMeijer, Inc.bea36d55-1a5d-40c0-b422-92fb36043ee62025-01-23WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC159d412c-6d1a-45d4-88c0-8c93960f946e2025-01-21WarningsExact identifier
application number: M022
SEACALL MouthwashMOUTHWASHGuangdong Quadrant Ecological Technology Co., Ltd.2c1a7eed-6a7c-eeb2-e063-6394a90aafcc2025-01-19WarningsExact identifier
application number: M022
BENZOCAINE RaspberryBENZOCAINEDarby Dental Supply, LLCdd805400-26c5-4c18-ade2-821298233f9b2025-01-17WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCc68fd8c7-7ec3-cc3f-e053-2995a90a43952025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.d22f7776-1b3c-4744-bcfe-8d9597218d732025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.9c6a26e8-1253-49f7-9ce2-45c0d39f05c52025-01-16WarningsExact identifier
application number: M022
Pearson Topical AnestheticBENZOCAINEPearson Dental Supplies INC.48178733-7433-41ec-b178-1314e0edab1a2025-01-16WarningsExact identifier
application number: M022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75065-033-06750650033061 TUBE in 1 CARTON (75065-033-06) / 120 g in 1 TUBE1 tube2026-08-01NoNoCurrent
75065-033-07750650033071 TUBE in 1 CARTON (75065-033-07) / 20 g in 1 TUBE1 tube2026-09-01YesNoCurrent