Firefly Anticavity Fluoride

Product NDC
66923-003
11-digit product format
669230003
Labeler code
66923
Product ID
66923-003_bcec5748-5675-4b7b-b844-2ffbac08e719
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
RINSE
Route
DENTAL
Labeler
Ranir LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-16
Substance
SODIUM FLUORIDE
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 packagepackage66923-00366923-003-34DDiscontinued by firm2026-10-05

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
Firefly Anticavity Fluoride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.5 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
240698Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e91ed8a1-0d45-402c-9c16-1ae72e695a37Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66923-003-34Firefly Anticavity Fluoride237 mL in 1 BOTTLERINSE2372
66923-003-43Firefly Anticavity Fluoride473 mL in 1 BOTTLERINSE4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66923-003FIREFLY ANTICAVITY FLUORIDE (SODIUM FLUORIDE) RINSE [RANIR LLC]2Current NDC, Legacy NDC, 2 package rows20241122_e91ed8a1-0d45-402c-9c16-1ae72e695a37.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 4 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye Free Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.46846abe-062d-a11f-e063-6294a90a73f32026-02-06WarningsExact identifier
application number: M008
Bismuth subsalicylateBISMUTH SUBSALICYLATESoftgel Healthcare Pvt Ltd18f59606-1498-bd0c-e063-6394a90a7df22026-01-27WarningsExact identifier
application number: M008
Stomach Relief, Ultra StrengthBISMUTH SUBSALICYLATEMarc Glassman, Inc.8e47d007-237c-45c7-88c5-83953a06e4bd2025-12-26WarningsExact identifier
application number: M008
Equate Bismuth Stomach Relief ChewBISMUTH SUBSALICYLATEWalmart09967ac3-0013-c6ea-e063-6294a90a38d42025-12-23WarningsExact identifier
application number: M008
Walgreens Bismuth Stomach ReliefBISMUTH SUBSALICYLATEWalgreens21db191a-89a4-9854-e063-6294a90adab72025-12-23WarningsExact identifier
application number: M008
Kaopectate Max Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratoriese7218045-a593-485b-a5ba-03f3b35cbec42025-12-19WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories2f6766a1-d775-40bf-a039-975ab47fcceb2025-12-19WarningsExact identifier
application number: M008
Kaopectate Peppermint Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratories0316f469-e9fa-47c3-bb20-bd4588b40bcc2025-12-19WarningsExact identifier
application number: M008
Kaopectate Vanilla Flavor Anti DiarrhealBISMUTH SUBSALICYLATEKramer Laboratories3ad310c8-3dfa-4435-87bf-17f1c0a9ca452025-12-19WarningsExact identifier
application number: M008
Meijer Bismuth Stomach ReliefBISMUTHMeijer26a65c79-3bc1-a424-e063-6394a90a848e2025-12-18WarningsExact identifier
application number: M008
Stomach Relief, 24-7 Life by 7-ElevenBISMUTH SUBSALICYLATE TABLET TABLET, CHEWABLELil' Drug Store products, Inc.45c206c3-5fea-2d33-e063-6394a90aa10f2025-12-12WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERite Aid Corporatione9f5b3c3-9585-448d-8134-2214b5d78db02025-12-10WarningsExact identifier
application number: M008
QC Stomach Relief Cherry FlavorBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)d019eef1-8817-4bd4-84cf-04fd6542ee1a2025-12-04WarningsExact identifier
application number: M008
QC Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63f191f1-b29f-4842-9d80-ac43117c23612025-12-04WarningsExact identifier
application number: M008
QC Anti Diarrheal Vanilla Regular FlavorBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)02737763-eb98-401d-942c-186c401a2d312025-12-04WarningsExact identifier
application number: M008
Pink-BismuthBISMUTH SUBSALICYLATEGuardian Drug Companycb7da2b4-5e44-488b-a6e7-362e9b06c49c2025-12-03WarningsExact identifier
application number: M008
QC Pink BismuthBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f69f5164-f227-4527-ac1c-cda213b96b252025-12-03WarningsExact identifier
application number: M008
Walgreen Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEWALGREENS CO.57e66873-ccbb-4ee1-bcb9-4925713793f72025-12-01WarningsExact identifier
application number: M008
Ultra Strength digestive reliefBISMUTH SUBSALICYLATEWALGREENS CO.756e7a47-7e14-4694-84fa-ca6396f7edcc2025-11-26WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN COMPANYe7878137-a640-4d48-a6d5-23975e8b064b2025-11-25WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSNe91ed8a1-0d45-402c-9c16-1ae72e695a372
240698sodium fluoride 0.5 MG/ML MouthwashSCDe91ed8a1-0d45-402c-9c16-1ae72e695a372
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSYe91ed8a1-0d45-402c-9c16-1ae72e695a372

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66923-003-3466923000334237 mL in 1 BOTTLE (66923-003-34) 237 ml2021-11-050000-00-00NoNoCurrent
66923-003-4366923000343473 mL in 1 BOTTLE (66923-003-43) 473 ml2021-06-160000-00-00NoNoCurrent