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 8 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief cherryBISMUTH SUBSALICYLATETopco Associates, LLC154b4b8f-c4d6-414b-aac3-88475669e19d2024-12-26WarningsExact identifier
application number: M008
Topco Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC7a5be682-f13b-41a4-bf8c-724bffab2e922024-12-26WarningsExact identifier
application number: M008
HEB Stomach Relief CherryBISMUTH SUBSALICYLATEH E B0277d4d7-c254-4eea-8f2e-4936d015a80f2024-12-26WarningsExact identifier
application number: M008
Equaline Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI716a7b86-4f6e-493d-ba29-d81f6ecafbf22024-12-20WarningsExact identifier
application number: M008
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
application number: M008
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
application number: M008
Stomach Relief, Caseys 4goodBISMUTH SUBSALICYLATE SUSPENSIONLil' Drug Store Products, Inc.030bb176-08ae-6c68-e063-6394a90af5272024-12-16WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCc73c6650-a7ac-4942-ae07-0bc660a0081f2024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Regular Strength Stomach Relief 527BISMUTH SUBSALICYLATE 525 MGStrategic Sourcing Services LLCf204f9ab-645b-4656-93a1-90aa4c3699222024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCd18cd615-912a-4853-bb2e-225960cfe08b2024-12-12WarningsExact identifier
application number: M008
Topcare Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC908da10c-2ed1-4917-a98b-bab63d7990d42024-12-09WarningsExact identifier
application number: M008
Careone Stomach ReliefBISMUTH SUBSALICYLATERetail Business Services, LLC.214f64c9-29e4-353d-e063-6294a90a12b42024-11-26WarningsExact identifier
application number: M008
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
application number: M008
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
application number: M008
ndc (product): 66923-003
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
application number: M008
RITE AID Regular Strength Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION48fe12a5-5ff0-4d35-8708-675de32a9ed02024-10-31WarningsExact identifier
application number: M008
Rite Aid Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach Relief Original FlavorBISMUTH SUBSALICYLATERITE AID CORPORATION5db6ad20-208e-4881-90fc-672762f70cca2024-10-30WarningsExact identifier
application number: M008
Rite Aid Regular Strngth Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION2c4acea0-dfa2-422d-a13f-17699de747e62024-10-30WarningsExact 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