Anticavity Fluoride Rinse

Product NDC
37808-163
11-digit product format
378080163
Labeler code
37808
Product ID
37808-163_500ee303-72f4-68d5-e063-6394a90ac6d4
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
H E B
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-29
Substance
SODIUM FLUORIDE
Active strength
.1 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-16337808-163-77DDiscontinued by firm2026-10-16

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage37808-16337808-163-77DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-16337808-163-77DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Fluoride Rinse
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313029Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
87327a36-a314-4daa-83b6-b4bd3e26bba2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-163-77Anticavity Fluoride Rinse500 mL in 1 BOTTLE, PLASTICMOUTHWASH50015
37808-163-86Anticavity Fluoride Rinse1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100015

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6FANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
THYMOLINACTIVE INGREDIENT3J50XA376EANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-163ANTICAVITY FLUORIDE RINSE (SODIUM FLUORIDE) MOUTHWASH [HEB]12Current NDC, Legacy NDC, 2 package rows20240922_87327a36-a314-4daa-83b6-b4bd3e26bba2.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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
application number: M021
Burts Bees Complete Multi-CareSODIUM FLUORIDEProcter & Gamble Manufacturing Company12615266-06e8-b891-e063-6394a90ad75d2026-02-02WarningsExact identifier
application number: M021
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Cars Chow CherrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d66ad5-cdae-52f4-e063-6294a90a8ee92026-02-01WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
application number: M021
ACT Kids Berry BlastSODIUM FLUORIDEChattem, Inc.4f81ea98-5c74-4473-9764-3f11d627cdf12026-02-01WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
application number: M021
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
application number: M021
Supersmile Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc24fee793-57ed-87e9-e063-6394a90ab4ce2026-01-28WarningsExact identifier
application number: M021
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
application number: M021
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
application number: M021
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN87327a36-a314-4daa-83b6-b4bd3e26bba215
313029sodium fluoride 0.2 MG/ML MouthwashSCD87327a36-a314-4daa-83b6-b4bd3e26bba215
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY87327a36-a314-4daa-83b6-b4bd3e26bba215
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY87327a36-a314-4daa-83b6-b4bd3e26bba215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-163-7737808016377500 mL in 1 BOTTLE, PLASTIC (37808-163-77) 500 ml2010-09-290000-00-00NoNoCurrent
37808-163-86378080163861000 mL in 1 BOTTLE, PLASTIC (37808-163-86) 1000 ml2010-09-290000-00-00NoNoCurrent