FDA.reportPublic FDA data

Complete Protection

Product NDC
11673-366
11-digit product format
116730366
Labeler code
11673
Product ID
11673-366_47b7d8f9-cce8-b0c4-e063-6394a90ae124
Type
HUMAN OTC DRUG
Nonproprietary name
Stannous fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL; ORAL
Labeler
Target
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-10
Marketing end
2028-08-31
Substance
STANNOUS FLUORIDE
Active strength
.15 g/100g
NDC exclude flag
No
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 packagepackage11673-36611673-366-19DDiscontinued by firm2026-10-15

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 · 7 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…

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
Complete Protection

Active Ingredients#

Ingredient, Strength table
IngredientStrength
STANNOUS FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FTR44B32QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416784Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
03708e08-0189-b83d-e063-6394a90a50e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-366-09Complete Protection113 g in 1 TUBEPASTE, DENTIFRICE1138
11673-366-09Complete Protection1 in 1 CARTONPASTE, DENTIFRICE18
11673-366-19Complete Protection226 g in 1 TUBEPASTE, DENTIFRICE2268
11673-366-19Complete Protection1 in 1 CARTONPASTE, DENTIFRICE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-366COMPLETE PROTECTION (STANNOUS FLUORIDE) PASTE, DENTIFRICE [TARGET]4Current NDC, 4 package rows20250126_03708e08-0189-b83d-e063-6394a90a50e6.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 47 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
application number: M021
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
application number: M021
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
application number: M021
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
application number: M021
Barbie Bubble Gum ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.dc5489e9-eeff-4db5-8793-21fb5bf4b2ef2024-05-10WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
application number: M021
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
application number: M021
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
application number: M021
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
application number: M021
DeCureSODIUM MONOFLUOROPHOSPHATEScope medical devices private limited590c4827-f036-45bd-af30-0a4853ca34472024-05-07WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
application number: M021
Toothpaste, plus ToothbrushSODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSHLil' Drug Store Products, Inc.15ac00f8-da51-6cea-e063-6294a90aeb812024-04-09WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company142bffe1-1e8c-8567-e063-6394a90af15a2024-03-21WarningsExact identifier
application number: M021
Made by Dentists Ultra Whitening Fresh MintSODIUM FLUORIDEMADE BY DENTISTS INCdbce2aba-48db-4e78-bf79-74f34868ee372024-03-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.13907bf6-9a95-c0b2-e063-6394a90a40422024-03-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN03708e08-0189-b83d-e063-6394a90a50e68
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD03708e08-0189-b83d-e063-6394a90a50e68
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY03708e08-0189-b83d-e063-6394a90a50e68
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY03708e08-0189-b83d-e063-6394a90a50e68
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY03708e08-0189-b83d-e063-6394a90a50e68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-366-09116730366091 TUBE in 1 CARTON (11673-366-09) / 113 g in 1 TUBE1 tube2024-02-102028-08-31NoNoHistorical
11673-366-1911673036619226 g in 1 TUBE226 gHistorical