Firefly Anticavity Fluoride

Product NDC
66923-003
Requested package NDC
66923-003-34
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 firm2026-09-14

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 1 of 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Diotame InstydoseBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b214128-6980-0f84-e063-6294a90ad8ca2026-09-10WarningsExact identifier
application number: M008
Regular Strength Pink BismuthBISMUTH SUBSALICYLATERaritan Pharmaceuticals Inc89d18117-f0af-408a-a5ae-19da841588062026-09-09WarningsExact identifier
application number: M008
Pepto Bismol UltraBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companyd800eb8c-42c8-fb12-e053-2a95a90af2a22026-09-09WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.a03fabe0-4839-480e-8890-278e573cf4cc2026-09-09WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.5fa794f9-440c-479c-961c-34d298bb532b2026-09-09WarningsExact identifier
application number: M008
DRx Choice Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERARITAN PHAMACEUTICALS INC75e8cd49-850f-4816-b350-ce76601ebfc02026-09-09WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporation90b0c541-2834-4ed7-9d01-76080dd730572026-09-09WarningsExact identifier
application number: M008
Pepto Bismol Fast Melts Fresh Berry FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company039391d0-9ec1-45a3-84fa-b5f591794e412026-09-08WarningsExact identifier
application number: M008
Kroger Regular Strength Pink BismuthBISMUTH SUBSALICYLATEKROGER COMPANY97175691-4881-450d-a14c-3413ab47a3ca2026-09-02WarningsExact identifier
application number: M008
Kroger Stomach ReliefBISMUTH SUBSALICYLATEKROGER COMPANY4963f568-9d8d-4ad0-b840-bed3f6f9cb7b2026-09-01WarningsExact identifier
application number: M008
Ultra Strength digestive reliefBISMUTH SUBSALICYLATETHE KROGER CO.5e288108-1578-4379-a3d6-44b4471876432026-09-01WarningsExact identifier
application number: M008
Kroger Digestive ReliefBISMUTH SUBSALICYLATEKROGER COMPANY2b32bee7-154a-4e5b-a811-066d1e6c5dcb2026-09-01WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.50a88db4-633d-d3bc-e063-6294a90a18c52026-08-29WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEH E B7d721ce3-746f-49aa-916d-eb5a8b3578132026-08-21WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporatione8107300-921c-4ba4-ad6e-f4cf1cd5c2952026-08-20WarningsExact identifier
application number: M008
CVS Health Anti-Diarrheal VanillaBISMUTH SUBSALICYLATECVS Pharmacy,Inc.ce1ed357-228b-452c-9bd4-6b0d20f41c1d2026-08-17WarningsExact identifier
application number: M008
CVS Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECVS PHARMACYa7fb56c5-9b34-48b8-a355-a16979a0aa7b2026-08-17WarningsExact identifier
application number: M008
regular strength pink bismuthBISMUTH SUBSALICYLATECVS PHARMACY, INC.2b2a1de0-12fa-4800-91e8-f70a405eec722026-08-17WarningsExact identifier
application number: M008
CVS Health Stomach relief Cherry FlavorBISMUTH SUBSALICYLATECVS PHARMACY,INC.c0bb2b6e-8187-495e-8eac-2324fae86cf52026-08-13WarningsExact identifier
application number: M008
CVS Stomach ReliefBISMUTH SUBSALICYLATECVSeb96b2bb-7b2a-4664-96ac-73c917c84c302026-08-13WarningsExact 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