Anticavity

Product NDC
49035-163
11-digit product format
490350163
Labeler code
49035
Product ID
49035-163_4bd46c09-9072-40c4-e063-6394a90a22a4
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
MOUTHWASH
Route
ORAL
Labeler
Walmart Inc.
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 · 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
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct49035-163EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49035-16349035-163-86EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
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
e79e43e6-d6b6-4df4-9d9f-fe9fe35f180dAvailable 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
49035-163-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
SORBITOLINACTIVE INGREDIENT506T60A25RANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2
WATERINACTIVE INGREDIENT059QF0KO0RANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-163ANTICAVITY (SODIUM FLUORIDE) MOUTHWASH [WAL-MART]15Current NDC, Legacy NDC, 1 package rows20240730_e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d.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 33 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB HEBuddyFLUORIDEHEBa6af1baf-17bf-428c-8744-1490359b0cfb2025-11-13WarningsExact identifier
application number: M021
Spearmint Whitening with Hemp OilSODIUM MONOFLUOROPHOSPHATEWhole Foodsa4714db7-abc4-1eff-e053-2995a90a77402025-11-13WarningsExact identifier
application number: M021
Complete Protection TPSTANNOUS FLUORIDERite Aidccad28b5-254e-679f-e053-2a95a90abdd52025-11-13WarningsExact identifier
application number: M021
Rite Aid Sensitivity and GumSTANNOUS FLUORIDERite Aided362e9c-2dab-1102-e053-2a95a90a76f32025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEMeijer, Inc.0338495b-08a5-047f-e063-6394a90aa1242025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDECVSb673f6cc-ae70-7161-e053-2a95a90af8cd2025-11-13WarningsExact identifier
application number: M021
CVS Sens WhtngSTANNOUS FLUORIDECVScba7a512-03bc-8ebc-e053-2995a90ae12b2025-11-13WarningsExact identifier
application number: M021
Equate Repair and ProtectSTANNOUS FLUORIDEWalmartc4807b2b-7ea9-cc28-e053-2995a90a348e2025-11-13WarningsExact identifier
application number: M021
Kids Strawberry FTPSODIUM MONOFLUOROPHOSPHATETarget253c7c90-5d82-b1e0-e063-6394a90a7a4b2025-11-13WarningsExact identifier
application number: M021
Sensitivity and GumSTANNOUS FLUORIDEDG Health (Rexall)039c6e46-f995-c744-e063-6294a90a537e2025-11-13WarningsExact identifier
application number: M021
Equate Optimal Care TP Equate Optimal Care TPSTANNOUS FLUORIDEWalmart Inc.1e65b83e-a51a-4adb-e063-6394a90a06b42025-11-13WarningsExact identifier
application number: M021
Sensitive Whitening AnticavitySTANNOUS FLOURIDETopco96384c9d-cb42-7654-e053-2995a90aac082025-11-13WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDERite Aidccad4383-4479-6175-e053-2a95a90a13a22025-11-13WarningsExact identifier
application number: M021
Restore and Defend Whitening TPSTANNOUS FLUORIDEKroger253ba5c0-f2ef-46e6-e063-6394a90ad9d52025-11-13WarningsExact identifier
application number: M021
Dr Tichenors With Extra Whitening and Tartar ControlSODIUM FLUORIDEDr. G. H. Tichenor's Antiseptic Companybce596e8-07eb-4e56-9007-9d283e14372d2025-11-12WarningsExact identifier
application number: M021
Kids Silly Strawberry TPSODIUM MONOFLUOROPHOSPHATEHEBab361305-01f9-7379-e053-2995a90a97b42025-11-12WarningsExact identifier
application number: M021
Care One Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDEFoodhold U.S.A.81a380eb-8605-b280-e053-2a91aa0abd4b2025-11-12WarningsExact identifier
application number: M021
365 Everyday Value Kids FlourideSODIUM MONOFLUOROPHOSPHATEWhole Foods Market, Inc.836f2df8-00b6-ff2d-e053-2991aa0a89582025-11-12WarningsExact identifier
application number: M021
CVS Rapid Protection SensitiveSTANNOUS FLUORIDECVS Pharmacy8162fcc0-7a24-678c-e053-2a91aa0af2fe2025-11-12WarningsExact identifier
application number: M021
Rite Aid Sensitive Rapid ProtectionSTANNOUS FLUORIDERite Aid8335dd4d-62a0-6861-e053-2a91aa0a82832025-11-12WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSNe79e43e6-d6b6-4df4-9d9f-fe9fe35f180d17
313029sodium fluoride 0.2 MG/ML MouthwashSCDe79e43e6-d6b6-4df4-9d9f-fe9fe35f180d17
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSYe79e43e6-d6b6-4df4-9d9f-fe9fe35f180d17
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSYe79e43e6-d6b6-4df4-9d9f-fe9fe35f180d17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-163-86490350163861000 mL in 1 BOTTLE, PLASTIC (49035-163-86) 1000 ml2006-05-130000-00-00NoNoCurrent