Home NDC 61649-734-01 BIO SPECTRA
Product NDC 61649-734
Requested package NDC 61649-734-01
11-digit product format 616490734
Labeler code 61649
Product ID 61649-734_186f0053-8c9b-d8b5-e063-6394a90af1c1
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler 9055-7588 Qu�bec Inc. DBA ATTITUDE
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-15
Substance SODIUM FLUORIDE
Active strength .243 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 Ingredient Strength SODIUM FLUORIDE .243 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 891775 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61649-734-01 BIO SPECTRAATTITUDE 120 g in 1 TUBE GEL, DENTIFRICE 120 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61649-734 BIO SPECTRA ATTITUDE (SODIUM FLUORIDE) GEL, DENTIFRICE [9055-7588 QUÉBEC INC. DBA ATTITUDE] 4 Current NDC, Legacy NDC, 1 package rows 20240516_fefc1060-e1a4-4686-a8d8-84bf1e613abe.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 31 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b68315c-6afa-3f37-e063-6294a90a14e8 2025-12-11 Warnings Exact identifier application number: M021 ANTICAVITY FLUORIDE SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 295b88e8-c4b5-c0b0-e063-6394a90aca01 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1b74f072-c33b-c6e2-e063-6394a90ab1e6 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1ba4a807-d6d5-04a0-e063-6294a90ae04d 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b617f4a-b56c-9f75-e063-6294a90a7abe 2025-12-11 Exact identifier application number: M021 BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 1b9ec370-eadf-92c4-e063-6294a90a9055 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD 1eb04296-ecb1-3ccc-e063-6294a90a9bda 2025-12-11 Warnings Exact identifier application number: M021 BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY SODIUM FLUORIDE Kingkey MBC Life Technology Group Co.,Ltd 1b9e7b21-0d34-74ec-e063-6294a90a1f59 2025-12-11 Exact identifier application number: M021 Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash SODIUM FLUORIDE Kenvue Brands LLC 28986d7f-3e9a-8dfb-e063-6394a90a731e 2025-12-10 Warnings Exact identifier application number: M021 Toms of Maine Tropical Island ALUMINUM CHLOROHYDRATE Colgate-Palmolive Company 0d6c51bc-5391-4533-b4fd-961dc4f36342 2025-12-10 Warnings Exact identifier application number: M021 Business Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. 483d7aec-34ac-49c5-ac0e-8fba5b4737ae 2025-12-09 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 121decce-c364-4060-87da-0c6a6cd48474 2025-12-08 Warnings Exact identifier application number: M021 First Class Kit SODIUM MONOFLUOROPHOSPHATE American Airlines, Inc. ba717de8-c3a2-41bf-85a1-aa75f9744d30 2025-12-08 Warnings Exact identifier application number: M021 United Airlines Business Class Kit SODIUM MONOFLUOROPHOSPHATE United Airlines 94c5e9a4-19f3-4590-9da4-313c75261231 2025-12-08 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 5f08d994-e458-42b2-aa39-e84fca3acf48 2025-12-05 Warnings Exact identifier application number: M021 Colgate Anticavity Kit SODIUM MONOFLUOROPHOSPHATE Ming Fai Industrial (Shenzhen) Co. Ltd 86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Nano-Hydroxyapatite SODIUM FLUORIDE Dr Jen Natural, LLC 8b28b857-9162-4065-b0a0-571efffe9787 2025-12-05 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Ortho SODIUM FLUORIDE Dr Jen Natural, LLC 9dd248bf-9488-43cd-a041-e8315a05ce5d 2025-12-04 Warnings Exact identifier application number: M021 Dr. Jen SuperPaste Perio SODIUM FLUORIDE Dr Jen Natural, LLC 8c7e6d3a-49d9-4098-9d5e-e9792b373574 2025-12-04 Warnings Exact identifier application number: M021 Colgate Total Plaque Cleanse STANNOUS FLUORIDE Colgate-Palmolive Company b2980238-5bcb-467f-9e90-a307938632c2 2025-12-03 Warnings Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61649-734-01 61649073401 120 g in 1 TUBE (61649-734-01) 120 g 2021-05-15 0000-00-00 No No Current