Burts Bees

Product NDC
69423-962
11-digit product format
694230962
Labeler code
69423
Product ID
69423-962_51b86222-3b3e-1b41-e063-6294a90a4013
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manufacturing Company
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-30
Substance
SODIUM FLUORIDE
Active strength
1.3 mg/g
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
Burts Bees
Brand name suffix
Extra White
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.3 mg/g

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
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c92524fd-8b93-592d-e053-2a95a90a88c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-962-03Burts BeesExtra White1 in 1 CARTONPASTE, DENTIFRICE19
69423-962-03Burts BeesExtra White3 in 1 CELLO PACKPASTE, DENTIFRICE39
69423-962-47Burts BeesExtra White1 in 1 CARTONPASTE, DENTIFRICE19
69423-962-47Burts BeesExtra White133 g in 1 TUBEPASTE, DENTIFRICE1339

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-962BURTS BEES EXTRA WHITE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 4 package rows20250116_c92524fd-8b93-592d-e053-2a95a90a88c6.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 41 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quip AnticavitySODIUM FLUORIDEQuip NYC Inc.b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a2025-01-30WarningsExact identifier
application number: M021
QuipSODIUM FLUORIDEQuip NYC Inc.714b7205-444d-929b-e053-2995a90a958e2025-01-30WarningsExact identifier
application number: M021
Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.7e8944d3-b8d6-44e6-b38b-f80e4cd28ee42025-01-29WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDOCSMEDI Co., Ltd.ea18ac56-4ef1-4bf0-8c26-6885183fd6842025-01-22WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDOCSMEDI Co., Ltd.aaf08481-a2ff-48f6-8611-73a469efe1db2025-01-22WarningsExact identifier
application number: M021
Double X CONCENTRATEDCETYLPYRIDINIUM CHLORIDEDOCSMEDI Co., Ltd.411be334-364c-4074-8d0b-8dda332f87de2025-01-22WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attituded33e3778-ba1d-4560-bafa-74f7ab88c6b52025-01-20WarningsExact identifier
application number: M021
AMERFRESH FLUORIDE gelSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD86279b4d-82e5-45b5-9ba7-94fe3620b8502025-01-16WarningsExact identifier
application number: M021
AMERFRESH FLUORIDESODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD827e45bb-84c0-48ee-a60b-2cc32b8f33e32025-01-16WarningsExact identifier
application number: M021
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel ToothSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTDbb93fb1a-885a-4d2a-a1c2-3b37bc305d572025-01-16WarningsExact identifier
application number: M021
MedprideSODIUM MONOFLUOROPHOSPHATEShield Line LLC9c1b0420-6b57-4914-99fe-df6a494815c32025-01-16WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC7a295974-c400-4442-9149-138a805ffb202025-01-09WarningsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.6398ae96-dd38-44da-bc34-1d4d4c4a78ca2025-01-08WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
application number: M021
PERIOE POP Sensitivity Care Prebiotic Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Sensitive Clean MintSTANNOUS FLUORIDETai Guk Pharm. Co., Ltd.dec29c9f-6ddb-0b4e-e053-2995a90a64b12025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Original Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8e5de76b-535a-9c95-e053-2995a90afcab2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.8f27c88a-7a70-e00a-e053-2a95a90a95a42025-01-01WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDETAI GUK PHARM. CO., LTD0abb7a95-60b1-a1f3-e063-6294a90ace0c2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials Blanc Charcoal Fresh MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.99fff177-6300-220e-e053-2a95a90a06602025-01-01WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSNc92524fd-8b93-592d-e053-2a95a90a88c69
891775sodium fluoride 0.00243 MG/MG ToothpasteSCDc92524fd-8b93-592d-e053-2a95a90a88c69
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSYc92524fd-8b93-592d-e053-2a95a90a88c69
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSYc92524fd-8b93-592d-e053-2a95a90a88c69
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSYc92524fd-8b93-592d-e053-2a95a90a88c69
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSYc92524fd-8b93-592d-e053-2a95a90a88c69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-962-03694230962033 CARTON in 1 CELLO PACK (69423-962-03) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2021-09-30NoNoCurrent
69423-962-47694230962471 TUBE in 1 CARTON (69423-962-47) / 133 g in 1 TUBE1 tube2021-09-300000-00-00NoNoCurrent