Botao Kids Strawberry Flavored with Fluoride

Product NDC
69435-1405
11-digit product format
694351405
Labeler code
69435
Product ID
69435-1405_482fd59d-1ef5-49c2-e063-6394a90a7c12
Type
HUMAN OTC DRUG
Nonproprietary name
Botao Kids Strawberry Flavored Toothpaste with Fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Peer Pharm Ltd.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-19
Substance
SODIUM FLUORIDE
Active strength
.122 g/100mL
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
Botao Kids Strawberry Flavored with Fluoride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.122 g/100mL

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
48b8d884-5e15-4145-8521-ae9ee482e392Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1405-1Botao Kids Strawberry Flavored with Fluoride1 in 1 CARTONPASTE13
69435-1405-1Botao Kids Strawberry Flavored with Fluoride75 mL in 1 TUBEPASTE753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69435-1405BOTAO KIDS STRAWBERRY FLAVORED WITH FLUORIDE (BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE) PASTE [PEER PHARM LTD.]2Current NDC, 2 package rows20241227_48b8d884-5e15-4145-8521-ae9ee482e392.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 34 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hello Whipped Mellow Mint Dream FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company7a72b687-475d-437a-9734-a29637e5516a2025-11-11WarningsExact identifier
application number: M021
Spry DentifriceTOOTHPASTEXlear Inc.43567bbc-b07e-b605-e063-6294a90aad782025-11-11WarningsExact identifier
application number: M021
Hello Naturally WhiteningSODIUM MONOFLUOROPHOSPHATECOLGATE PALMOLIVE COMPANY5ad241e1-6bfc-7863-6a7a-100753651f0a2025-11-11WarningsExact identifier
application number: M021
Hello Whipped Peppermint Stick FlavorSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyd6c4ac9e-f55e-4ebc-bd6a-e39eaeb4f8132025-11-11WarningsExact identifier
application number: M021
Super MintMINT TOOTHPASTESuperMouth, LLC.d23e89f5-7b65-4ed9-803a-38233f30d8f22025-11-07WarningsExact identifier
application number: M021
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.51f1d84c-809a-4c96-a117-7a8d8aa1e6b42025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.c44686f8-93ee-4a8f-8481-3439d123f6d22025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.16ebcb37-5703-4e10-b965-570e18434b522025-11-04WarningsExact identifier
application number: M021
Plak Smacker GREAT WHITE SHARKSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCca5b91aa-f69c-4553-a2b6-acf0ca1d920e2025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65fa41e-ce2e-53e4-e053-2995a90a24d22025-11-04WarningsExact identifier
application number: M021
Plak SmackerSTANNOUS FLUORIDEYoung Innovations, Inc.e65c62d9-e8a6-3101-e053-2995a90a14942025-11-04WarningsExact identifier
application number: M021
Home Care FluorideSTANNOUS FLUORIDEDental Technologies, Inc.15bdc03e-2cc7-4b7d-96fc-4f3236ed5c752025-11-04WarningsExact identifier
application number: M021
Strawberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426c2aca-ca2b-5e34-e063-6294a90ae37c2025-11-02WarningsExact identifier
application number: M021
Watermelon Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426e40cb-e30d-0db1-e063-6294a90a762b2025-10-31WarningsExact identifier
application number: M021
Classic Mint Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425a9b71-5a7f-83e6-e063-6394a90ab7032025-10-30WarningsExact identifier
application number: M021
Grape Bubblegum Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD425b1a2e-7576-13a7-e063-6394a90aa8652025-10-30WarningsExact identifier
application number: M021
The Simpsons Pink Donut Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD426b8efa-e691-a67d-e063-6394a90abf8d2025-10-30WarningsExact identifier
application number: M021
Blue Raspberry Flavor Sodium Fluoride Anticavity ToothpastSODIUM FLUORIDEHISMILE PTY LTD42583b32-525f-925d-e063-6294a90af76f2025-10-29WarningsExact identifier
application number: M021
PERIOE KAKAO KIDS StrawberrySODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.4239f8c2-a5f5-3fa6-e063-6294a90acb472025-10-28WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN48b8d884-5e15-4145-8521-ae9ee482e3923
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD48b8d884-5e15-4145-8521-ae9ee482e3923
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY48b8d884-5e15-4145-8521-ae9ee482e3923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69435-1405-1694351405011 TUBE in 1 CARTON (69435-1405-1) / 75 mL in 1 TUBE1 tube2022-12-19NoNoCurrent