FDA.reportPublic FDA data

botalab HERBAL COMPLETE TOOTH

Product NDC
50555-201
11-digit product format
505550201
Labeler code
50555
Product ID
50555-201_51365ef7-ed95-2650-e063-6394a90ab89e
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
KMPHARMACEUTICAL CO., LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-01
Substance
SODIUM FLUORIDE
Active strength
.22 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
botalab HERBAL COMPLETE TOOTH
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.22 g/100g

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
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
51365ef7-ed94-2650-e063-6394a90ab89eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50555-201-01botalab HERBAL COMPLETE TOOTH150 g in 1 TUBEPASTE, DENTIFRICE1501
50555-201-02botalab HERBAL COMPLETE TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

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 42 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact identifier
application number: M021
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN51365ef7-ed94-2650-e063-6394a90ab89e1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD51365ef7-ed94-2650-e063-6394a90ab89e1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY51365ef7-ed94-2650-e063-6394a90ab89e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50555-201-0150555020101150 g in 1 TUBE150 gHistorical
50555-201-02505550201021 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01) 1 tube2026-05-01NoNoCurrent