FDA.reportPublic FDA data

United Airlines Therabody Polaris Kit

Product NDC
42509-135
11-digit product format
425090135
Labeler code
42509
Product ID
42509-135_08ab1b81-1f73-8a8d-e063-6394a90aa816
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
KIT
Labeler
Wessco International
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
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
United Airlines Therabody Polaris Kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab667740-55ab-470e-9514-163961502cebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42509-135-01United Airlines Therabody Polaris Kit1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42509-135UNITED AIRLINES THERABODY POLARIS KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [WESSCO INTERNATIONAL]2Current NDC, 1 package rows20231027_ab667740-55ab-470e-9514-163961502ceb.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 22 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prime Tooth Care Mango SmoothieSODIUM FLUORIDEPrime Tooth Care LLC2f2cf851-2edc-4aaf-9083-c37bc58547de2026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care StrawberriesSODIUM FLUORIDEPrime Tooth Care LLC7b4328bd-5d2d-40ca-8322-5e818e1babf92026-01-09WarningsExact identifier
application number: M021
Prime Tooth Care Summer WatermelonSODIUM FLUORIDEPrime Tooth Care LLCb7c731a1-80e7-4571-a568-db0290a720c12026-01-09WarningsExact identifier
application number: M021
Kids Prime Pediatric Dental Group Anticavity for KidsSODIUM FLUORIDEPrime Tooth Care LLC93259174-447d-4f7a-8e55-990eb8da51512026-01-09WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Enamel ProtectSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf32d5708-8cb1-6499-e053-2995a90ac6322026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Complete Care Anticavity FluorideSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3a644c0-da04-276d-e053-2a95a90abf272026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Active RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4487d78-1da8-3f33-e053-2a95a90a6d922026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Sensitive CareSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf435c1fe-7fbb-1b25-e053-2995a90aca112026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Densify Pro Intensive RepairSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf45c9c89-f294-deca-e053-2a95a90ae5572026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a00de-b16a-66e6-e053-2995a90aedc62026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Detoxify Gentle WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf49a7dc7-77f3-3911-e053-2a95a90ad55c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus Cinnamon ExpressionsSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company961295a6-79ae-44b1-e053-2995a90a61302026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Intensive CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2118d-1216-d0d0-e053-2995a90a70882026-01-08WarningsExact identifier
application number: M021
Crest 3D White CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company96247083-39e9-7ca7-e053-2995a90a75d02026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Express WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4c2d5aa-b0e6-7068-e053-2995a90ae90c2026-01-08WarningsExact identifier
application number: M021
Crest complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company973ce138-c64e-c059-e053-2a95a90a31482026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4c3ad36-72d8-16e8-e053-2a95a90a87022026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Gum Detoxify and Restore Pro WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d65b58-9818-820d-e053-2995a90a9f002026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Sensitive and Gum All Day ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4d775a1-a4f6-cd69-e053-2995a90a5f642026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Enamel Repair and Gum Advanced WhiteningSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf4ead762-17b2-22a0-e053-2a95a90ac8662026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSNab667740-55ab-470e-9514-163961502ceb2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDab667740-55ab-470e-9514-163961502ceb2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYab667740-55ab-470e-9514-163961502ceb2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYab667740-55ab-470e-9514-163961502ceb2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYab667740-55ab-470e-9514-163961502ceb2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYab667740-55ab-470e-9514-163961502ceb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42509-135-01425090135011 KIT in 1 KIT (42509-135-01) * 5 g in 1 TUBE (42555-060-94) 1 kit2023-06-01NoNoCurrent