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 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

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