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 32 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORGANIC PEPPERMINT HERB THROAT DROPSMENTHOLRicola USA Inc.f75c8967-40e6-473a-b403-941354cb0be12024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.c56be34d-1dd5-4200-9723-3a73180cb7592024-12-10WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola USA Inc.89257ceb-af0f-4516-88f7-6dfdab9e14f42024-12-10WarningsExact identifier
application number: M022
BERRY MEDLEY THROAT DROPSMENTHOLRicola USA Inc.9bfd2ea7-745b-47f8-bd8a-9dbeeaad8b952024-12-10WarningsExact identifier
application number: M022
NATURAL LEMON MINT HERB THROAT DROPSMENTHOLRicola USA Inc.6a81e5c7-834d-44da-853f-8f61032363112024-12-10WarningsExact identifier
application number: M022
SUGAR FREE SWISS CHERRY HERB THROAT DROPSMENTHOLRicola USA Inc.8a24f614-8e21-4ab2-8c0e-6af947911ccd2024-12-10WarningsExact identifier
application number: M022
RICOLA MAX NASAL CARE COOL MENTHOLMENTHOLRicola USA Inc.a2e189a2-65ae-48a9-99ad-8795334082df2024-12-10WarningsExact identifier
application number: M022
COOL RELIEF LEMON FROST ORAL ANESTHETICMENTHOLRicola USA Inc.40c3a80a-a116-4607-bb4a-c89d255ee0762024-12-10WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola USA Inc.d66f47a9-35ab-4bf9-8065-c81abcb503f52024-12-10WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola USA Inc.62a631d3-e6d0-4fca-ad0c-7c1b67d2a8272024-12-10WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola USA Inc.3f93919f-e63e-470d-9d9a-f6ea3492c23d2024-12-10WarningsExact identifier
application number: M022
Throat Balm Caramel PectinPECTINRicola USA Inc.23cf2ba5-9d4d-409b-ab0e-a1d702f0bb152024-12-10WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola USA Inc.4cbf9094-6b50-4bef-bb36-2df6cb868ac72024-12-10WarningsExact identifier
application number: M022
SUCRETS VAPOR CHERRYDYCLONINE HYDROCHLORIDE AND MENTHOLInsight Pharmaceuticals LLC471af502-5b3a-4897-b22d-78859b73a2172024-12-05WarningsExact identifier
application number: M022
Cherry Throat DropsMENTHOLRicola Agbb236392-1f7c-4cb5-ae9a-9cb1c60d133e2024-12-05WarningsExact identifier
application number: M022
RICOLA MAX NASAL CARE COOL MENTHOLMENTHOLRicola Agdfecd10f-adbe-4be7-854d-f9f202fef1452024-12-05WarningsExact identifier
application number: M022
COOL RELIEF ORAL ANESTHETICMENTHOLRicola Ag3698a69f-b5c0-4235-8ef8-71c867f1ac0d2024-12-05WarningsExact identifier
application number: M022
Throat Balm Caramel PectinPECTINRicola Agedbd7a73-8f06-4a1e-a459-3d7a4355fc9b2024-12-05WarningsExact identifier
application number: M022
SUGAR FREE SWISS CHERRY HERB THROAT DROPSMENTHOLRicola Age2a939a5-4447-4707-865c-70de9a0471c62024-12-05WarningsExact identifier
application number: M022
Natural Cherry Honey Herb Throat DropsMENTHOLRicola Agec6cad6b-9e92-44c9-a470-cf924fb1b6d72024-12-05WarningsExact 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