FDA.reportPublic FDA data

BIO SPECTRA

Product NDC
61649-733
11-digit product format
616490733
Labeler code
61649
Product ID
61649-733_124a286a-fd2a-6d1d-e063-6294a90a6c18
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium fluoride and Potassium nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
9055-7588 Quebec Inc. DBA Attitude
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-26
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.243; 5 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
BIO SPECTRA
Brand name suffix
ATTITUDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 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
1038800Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42b79ec5-f37f-4dc9-9631-c8b1c153fe88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61649-733-01BIO SPECTRAATTITUDE120 g in 1 TUBEPASTE, DENTIFRICE1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61649-733BIO SPECTRA ATTITUDE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE]5Current NDC, Legacy NDC, 1 package rows20240426_42b79ec5-f37f-4dc9-9631-c8b1c153fe88.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
application number: M022
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
application number: M022
Orajel 2X Medicated GelORAL PAIN RELIEVERChurch & Dwight Co., Inc.262be295-4eaf-3136-e063-6294a90a7dcc2024-11-05WarningsExact identifier
application number: M022
BIOTENE Fresh Mint OriginalSODIUM FLUORIDEHaleon US Holdings LLC1101c17f-c848-4cd5-a7cd-679b59dbe1bf2024-11-05WarningsExact identifier
application number: M022
bioteneSODIUM MONOFLUOROPHOSPHATEHaleon US Holdings LLCa47a6502-efb2-4072-9562-cbe293531c2b2024-11-04WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser CherrySODIUM PERBORATE MONOHYDRATEVintage Brands Limiteda0e145c8-6b08-40be-ae4f-5678c4a78b1e2024-10-30WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33b-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043bfbc3-c33a-78b7-e063-6294a90a1a5a2024-10-29WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043a3cb4-f560-0ffd-e063-6394a90a2ff62024-10-29WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser MintSODIUM PERBORATE MONOHYDRATEVintage Brands Limitedbe57ca56-834f-4170-a407-f193484d8b0a2024-10-29WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean MintSODIUM FLUORIDEHaleon US Holdings LLC817c0dad-d109-428e-adb5-3354604acc942024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC1f3d68f6-afd6-42e7-b3e5-210228c8e7de2024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals LLC0dd15227-6603-42ac-9a5f-f2dc49e0382a2024-10-28Warnings, Adverse reactionsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0605d5d6-82bd-415e-b5cb-e273f934a4a72024-10-28WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLCf70fa3fc-cd65-4a80-9efd-129e98fd39982024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
application number: M022
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
application number: M022
Ear Wax Removal Aid DropsCARBAMIDE PEROXIDEPHARMACY VALUE ALLIANCE, LLC85ae80c1-2bc2-4c90-9559-63510d03e7392024-10-28WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) ToothpastePSN42b79ec5-f37f-4dc9-9631-c8b1c153fe885
1038800potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG ToothpasteSCD42b79ec5-f37f-4dc9-9631-c8b1c153fe885
1038800K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY42b79ec5-f37f-4dc9-9631-c8b1c153fe885
1038800Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG ToothpasteSY42b79ec5-f37f-4dc9-9631-c8b1c153fe885
1038800potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY42b79ec5-f37f-4dc9-9631-c8b1c153fe885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61649-733-0161649073301120 g in 1 TUBE (61649-733-01) 120 g2024-04-260000-00-00NoNoCurrent