DG health

Product NDC
55910-360
11-digit product format
559100360
Labeler code
55910
Product ID
55910-360_47e5ca32-e2e0-9ad9-e063-6394a90a1e39
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Dolgencorp, LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-13
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.24; 5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct55910-360UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55910-36055910-360-39UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
DG health
Brand name suffix
Sensitive Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.24 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
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
81cd5d37-3751-625f-e053-2a91aa0a6dfdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-360-39DG healthSensitive Maximum Strength113 g in 1 TUBEPASTE, DENTIFRICE1139
55910-360-39DG healthSensitive Maximum Strength1 in 1 CARTONPASTE, DENTIFRICE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-360DG HEALTH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [DOLGENCORP, LLC]8Current NDC, Legacy NDC, 2 package rows20250121_81cd5d37-3751-625f-e053-2a91aa0a6dfd.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 21 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HISMILESODIUM FLUORIDEHISMILE PTY LTD1de591d9-9cab-e63d-e063-6394a90ac8eb2026-01-15WarningsExact identifier
application number: M021
Ice Pop Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD20e1603e-bcd1-6a5e-e063-6294a90ad1db2026-01-15WarningsExact identifier
application number: M021
HismileCANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTEHISMILE PTY LTD1e725b7e-accc-f51c-e063-6394a90a455c2026-01-15WarningsExact identifier
application number: M021
Enamelon Preventive TreatmentSTANNOUS FLUORIDEPremier Dental Products Company04c3f178-7905-404d-9ac2-67c453287ddf2026-01-13WarningsExact identifier
application number: M021
EnamelonSTANNOUS FLUORIDEPremier Dental Products Company1626375a-f78b-4192-b7f3-ca932acab7fb2026-01-13WarningsExact identifier
application number: M021
ARU CAVITY PROTECTIONSODIUM FLUORIDEAshtel Studios, Inc.97bd2934-4bff-4fdb-9199-fcdc0f77fada2026-01-13WarningsExact identifier
application number: M021
ACT Anticavity Fluoride CinnamonSODIUM FLUORIDEChattem, Inc.f2952ca5-c1c3-42fc-82a4-08662286be442026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Wild WatermelonSODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION)Chattem, Inc.bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a82026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Pineapple PunchSODIUM FLUORIDEChattem, Inc.2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b2026-01-12WarningsExact identifier
application number: M021
Botao Kids Strawberry Flavored with FluorideBOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDEPeer Pharm Ltd.48b8d884-5e15-4145-8521-ae9ee482e3922026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Fresh MintSODIUM FLUORIDEChattem, Inc.4ee6a478-afcf-4540-b427-ba08c942ccb32026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride MintSODIUM FLUORIDEChattem, Inc.e81c83a2-363a-442f-8731-2598a4f4c21e2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.258b78b4-55e7-410c-90f8-a3e456c025792026-01-12WarningsExact identifier
application number: M021
ACT Total Care Dry Mouth Anticavity MouthSODIUM FLUORIDEChattem, Inc.06684b82-aaa0-4ca6-8d56-4f98662690002026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids Groovy GrapeSODIUM FLUORIDEChattem, Inc.cd167c0b-2086-4204-b0ac-90df404bd4bb2026-01-12WarningsExact identifier
application number: M021
ACT Total Care Anticavity Fluoride Icy Clean MintSODIUM FLUORIDEChattem, Inc.beded786-bb55-4ba3-82fe-9e9d1b5e29792026-01-12WarningsExact identifier
application number: M021
ACT Kids Pure Protect Anticavity- Simply StrawberrySODIUM FLUORIDEChattem, Inc.2fc80727-57c7-4a33-80e0-ab9f9487390d2026-01-12WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Groovy GrapeSODIUM FLUORIDEChattem, Inc.310a3c11-1c66-4dac-99f4-5fdc15d0f77c2026-01-12WarningsExact identifier
application number: M021
ACT Anticavity Fluoride Kids BubblegumSODIUM FLUORIDEChattem, Inc.fbbccd58-a816-4a93-a658-f28246c11e802026-01-12WarningsExact identifier
application number: M021
ACT Whitening Anticavity Gentle MintSODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION)Chattem, Inc.cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf492026-01-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY81cd5d37-3751-625f-e053-2a91aa0a6dfd9
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY81cd5d37-3751-625f-e053-2a91aa0a6dfd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-360-39559100360391 TUBE in 1 CARTON (55910-360-39) / 113 g in 1 TUBE1 tube2019-02-130000-00-00NoNoCurrent