Pronamel Repair Whitening

Product NDC
56062-514
11-digit product format
560620514
Labeler code
56062
Product ID
56062-514_437fb5ce-7bc7-ad3e-e063-6394a90a6b66
Type
HUMAN OTC DRUG
Nonproprietary name
Pronamel Repair Whitening
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Publix Super Market Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Pronamel Repair Whitening
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal 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
16ee2625-3641-205d-e063-6394a90a742fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56062-514-44Pronamel Repair Whitening96.3 g in 1 TUBEPASTE, DENTIFRICE96.36
56062-514-44Pronamel Repair Whitening1 in 1 CARTONPASTE, DENTIFRICE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56062-514PRONAMEL REPAIR WHITENING PASTE, DENTIFRICE [PUBLIX SUPER MARKET INC]4Current NDC, 2 package rows20250119_16ee2625-3641-205d-e063-6394a90a742f.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 27 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Primo Topical AnestheticBENZOCAINETri State Dentalf7862ee9-117a-493d-83ee-5aef588a86de2025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental011c6a04-a489-41a5-ad2f-8ec281e079332025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental45422b0f-f1ac-4bec-851a-c1394bc52fcc2025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c336f-60e3-dc23-e063-6294a90a4b132025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCe67b8def-c728-4952-9b35-874643cbe0f12025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCe628bd9f-99e5-4c71-ba8a-caa6c337de542025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCfef1f48c-e89d-4b75-9ba0-b1b068daf5822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalb18c2bfc-638e-40a7-8ecb-60303aa3f5192025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental64b9ebe6-afbe-4db2-b4bf-14ff5d007ea02025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalf5d37a12-9db1-4f2c-9dd1-72a8361e0e572025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalcb25c40b-07ef-44b8-9f48-0b8f3f78c8822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental3ad7867c-b584-4355-9fd7-7582919751bd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa7d4e2-9154-4c34-a1ec-d89231eda4472025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc385cc66-7d08-4b63-bfba-a133b5275c6d2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsddc81125-e12b-4170-938d-df7a624a7dfd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa1390b-d060-43a4-87ee-1497fa82e21b2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc78b5f2b-4434-4f36-82e3-781409db41622025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Products4545ab53-aa2d-41c4-9395-50bb64c196632025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCc113773b-dfb0-4797-ae0e-ecc06bfffd682025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLC31232583-180c-43d1-bc45-c3f6d9ea50812025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN16ee2625-3641-205d-e063-6394a90a742f6
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD16ee2625-3641-205d-e063-6394a90a742f6
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16ee2625-3641-205d-e063-6394a90a742f6
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY16ee2625-3641-205d-e063-6394a90a742f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56062-514-44560620514441 TUBE in 1 CARTON (56062-514-44) / 96.3 g in 1 TUBE1 tube2024-09-01NoNoCurrent