CVS Health Sensitive Enamel Repair

Product NDC
51316-169
11-digit product format
513160169
Labeler code
51316
Product ID
51316-169_47f95dac-296a-3639-e063-6394a90abc25
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
CVS
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-08
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.15; 5 g/100g; g/100g
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
CVS Health Sensitive Enamel Repair
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41d547b3-2feb-8e83-e063-6294a90ae3cdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-169-10CVS Health Sensitive Enamel Repair96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
51316-169-10CVS Health Sensitive Enamel Repair1 in 1 CARTONPASTE, DENTIFRICE12

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 29 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BencoCaine Topical AnestheticBENZOCAINEBenco Dental3cc5d095-5f9c-4e4d-8971-0079e949b7ca2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89d23b14-398e-4b3e-955a-724ff66579b92025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentale381b2d5-6485-4d11-94f4-eec335d5cf412025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental8ffc4af6-d99c-4964-8d7d-4644bc699a3d2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a932-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05e31aaa-a934-f48b-e063-6394a90af32e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9236161b-a427-6efa-e053-2a95a90a99c42025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9224ecb4-c58f-ae7d-e053-2995a90ac2ed2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923614c5-d1bf-b444-e053-2995a90aa5c62025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235cb3f-a45b-10e5-e053-2995a90ae5e32025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.923636fb-8f9a-480b-e053-2995a90a618e2025-01-08WarningsExact identifier
application number: M022
Safco Sensicaine Ultra Topical Anesthetic GelBENZOCAINESafco Dental Supply Co.9235fd71-3dd9-436a-e053-2995a90af7ec2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3fe5283f-967b-4f57-941b-ab80ea40ce502025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental4860dc44-6811-4db5-aeda-05fac830b1882025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental7619d53c-3f6e-4041-93a1-df33d5f9e3f72025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalb2cd6d74-b35a-4cc1-8752-519bce9047372025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentala948c5a7-d431-4f46-bb59-8974924e63202025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental18d2e370-b30e-4b50-85d8-265964be2dde2025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dental3eb3bbc6-07d4-44c5-adac-701db06f9cd82025-01-08WarningsExact identifier
application number: M022
Patterson Dental Topical AnestheticBENZOCAINEPatterson Dentalfcfcece3-ee81-4275-82e2-aba93a6862ee2025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN41d547b3-2feb-8e83-e063-6294a90ae3cd2
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD41d547b3-2feb-8e83-e063-6294a90ae3cd2
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY41d547b3-2feb-8e83-e063-6294a90ae3cd2
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY41d547b3-2feb-8e83-e063-6294a90ae3cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-169-10513160169101 TUBE in 1 CARTON (51316-169-10) / 96.4 g in 1 TUBE1 tube2026-01-08NoNoCurrent