Home NDC 55910-163 Anticavity
Product NDC 55910-163
11-digit product format 559100163
Labeler code 55910
Product ID 55910-163_4c0f0ffe-bed6-25e9-e063-6294a90a04dd
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form MOUTHWASH
Route ORAL
Labeler Old East Main Co.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-05-13
Substance SODIUM FLUORIDE
Active strength .1 mg/mL
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 55910-163 55910-163-86 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 Anticavity
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE .1 mg/mL
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 313029 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55910-163-85 Anticavity 250 mL in 1 BOTTLE, PLASTIC MOUTHWASH 250 19 55910-163-86 Anticavity 1000 mL in 1 BOTTLE, PLASTIC MOUTHWASH 1000 19
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 ALCOHOL INACTIVE INGREDIENT 3K9958V90M ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 EUCALYPTOL INACTIVE INGREDIENT RV6J6604TK ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 MENTHOL INACTIVE INGREDIENT L7T10EIP3A ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 METHYL SALICYLATE INACTIVE INGREDIENT LAV5U5022Y ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 POLOXAMER 407 INACTIVE INGREDIENT TUF2IVW3M2 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT 22ADO53M6F ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 THYMOL INACTIVE INGREDIENT 3J50XA376E ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [DOLGENCORP, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-163 ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [OLD EAST MAIN CO.] 15 Current NDC, Legacy NDC, 2 package rows 20240918_64f3d92d-f58c-4bc2-8819-f91492221ddb.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 47 of 49 · 972 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Maximum Security SODIUM FLUORIDE Bob Barker Company Inc. e29f30ec-72ea-4944-a2c2-b1696d31b639 2024-02-27 Warnings Exact identifier application number: M021 Made by Dentists For Kids Monster Slime Sour Apple SODIUM FLUORIDE MADE BY DENTISTS INC dfddc67c-3626-48c4-8120-bcc6c455d119 2024-02-23 Warnings Exact identifier application number: M021 Orajel Gabbys Dollhouse SODIUM FLUORIDE Church & Dwight Co., Inc. cd47bd1e-44ac-465f-8529-6073ade14706 2024-02-23 Warnings Exact identifier application number: M021 Colgate Kids Maximum Cavity Protection SODIUM FLUORIDE Colgate-Palmolive c44c7a7e-fc3e-a81b-1961-ff89614b678f 2024-02-22 Warnings Exact identifier application number: M021 TheraBreath Fresh Breath Anticavity Mild Mint SODIUM FLUORIDE Church & Dwight Co., Inc. 19ce5324-7d8d-4d70-ad9b-238f7e612eac 2024-02-06 Warnings Exact identifier application number: M021 Nature Mint Anticavity SODIUM MONOFLUOROPHOSPHATE Bob Barker Company Inc. 916891d3-5234-46a8-a492-21a31f36a852 2024-02-02 Warnings Exact identifier application number: M021 Treatment Rinse Mint ANTICARIES DENTAL ALLIANCE HOLDINGS LLC f1255065-b7c3-4eb6-e053-2995a90afcdb 2024-01-31 Warnings Exact identifier application number: M021 Maintenance Rinse Mint ANTICARIES Dental Alliance Holdings LLC f1273510-aa83-3ef9-e053-2a95a90aea27 2024-01-31 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 50G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98d839e3-a1aa-c83d-e053-2995a90a7e79 2024-01-30 Warnings Exact identifier application number: M021 ATOMY PROPOLIS TOOTHPAS TE 200G SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE ATOMY CO., LTD. 98aebbec-aec0-1478-e053-2a95a90a03ea 2024-01-30 Warnings Exact identifier application number: M021 Toms Childrens Anticavity Mouthwash Silly Strawberry SODIUM FLUORIDE Tom's of Maine, Inc. 998c6f35-20f4-4cb8-bc48-6aa39e61481a 2024-01-18 Warnings Exact identifier application number: M021 Gel-Kam Fruit and Berry STANNOUS FLUORIDE Colgate Oral Pharmaceuticals, Inc. 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c 2024-01-18 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 9a976ac8-d966-4d94-93da-45652f2d2481 2024-01-12 Warnings Exact identifier application number: M021 Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride SODIUM FLUORIDE Colgate Oral Pharmaceuticals, Inc. 2b4b6f9a-0e31-4891-8721-d1b9a58cca96 2024-01-12 Warnings Exact identifier application number: M021 Colgate MaxFresh with Mini Breath Cool Mint SODIUM FLUORIDE Colgate-Palmolive Company 51abd6bc-7a3d-4b0e-a810-af9e94926438 2024-01-09 Warnings Exact identifier application number: M021 Colgate Enamel Strength Mouthwash SODIUM FLUORIDE Colgate-Palmolive - do not use f0cca38b-c0a3-4788-8cca-727a5684c16b 2024-01-09 Warnings Exact identifier application number: M021 PerCara Oral Health Rinse Fresh Mint CETYLPYRIDINIUM CHLORIDE LEC Custom Products, Inc bd98c654-218b-15ac-e053-2a95a90a75d1 2024-01-01 Warnings Exact identifier application number: M021 PerCara Kids Bubble Gum SODIUM FLUORIDE LEC Custom Products, Inc. be3a7272-acfb-7d14-e053-2995a90a9420 2024-01-01 Warnings Exact identifier application number: M021 Murchison Hume Dental Kit SODIUM MONOFLUOROPHOSPHATE Buzz Products Inc. b1a442e1-86cf-cba6-e053-2995a90a593a 2023-12-20 Warnings Exact identifier application number: M021 United Airlines Polaris Kit with Colgate SODIUM MONOFLUOROPHOSPHATE Buzz Export Services Pty Ltd (Buzz Products) de4564a4-1012-baad-e053-2a95a90a11b7 2023-12-20 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 55910-163-85 55910016385 250 mL in 1 BOTTLE, PLASTIC (55910-163-85) 250 ml 2025-09-09 No No Current 55910-163-86 55910016386 1000 mL in 1 BOTTLE, PLASTIC (55910-163-86) 1000 ml 2006-05-13 0000-00-00 No No Current