FDA.reportPublic FDA data

Burts Bees

Product NDC
69423-835
11-digit product format
694230835
Labeler code
69423
Product ID
69423-835_49dcc24a-e801-954a-e063-6294a90aadeb
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
2020-01-01
Substance
SODIUM FLUORIDE
Active strength
1.3 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Burts Bees
Brand name suffix
Complete Multi-Care
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-835-14Burts BeesComplete Multi-Care1 in 1 CARTONPASTE, DENTIFRICE19
69423-835-14Burts BeesComplete Multi-Care3 in 1 CELLO PACKPASTE, DENTIFRICE39
69423-835-47Burts BeesComplete Multi-Care1 in 1 CARTONPASTE, DENTIFRICE19
69423-835-47Burts BeesComplete Multi-Care133 g in 1 TUBEPASTE, DENTIFRICE1339

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-835BURTS BEES COMPLETE MULTI-CARE (SODIUM FLUORIDE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 4 package rows20250215_12615266-06e8-b891-e063-6394a90ad75d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN12615266-06e8-b891-e063-6394a90ad75d9
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD12615266-06e8-b891-e063-6394a90ad75d9
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY12615266-06e8-b891-e063-6394a90ad75d9
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY12615266-06e8-b891-e063-6394a90ad75d9
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY12615266-06e8-b891-e063-6394a90ad75d9
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY12615266-06e8-b891-e063-6394a90ad75d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-835-14694230835143 CARTON in 1 CELLO PACK (69423-835-14) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2020-01-01NoNoCurrent
69423-835-47694230835471 TUBE in 1 CARTON (69423-835-47) / 133 g in 1 TUBE1 tube2020-01-01NoNoCurrent