FDA.reportPublic FDA data

ROROBELL WAWA Kids Tooth Natural Green Grape Flavor

Product NDC
81275-015
Requested package NDC
81275-015-02
11-digit product format
812750015
Labeler code
81275
Product ID
81275-015_586b49cd-ebda-73cd-e063-6294a90ad56c
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrated Silica, Sodium Fluoride, Tocopheryl Acetate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
ROROBELL
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-08-01
Substance
SODIUM MONOFLUOROPHOSPHATE; HYDRATED SILICA; .ALPHA.-TOCOPHEROL ACETATE
Active strength
.22; 13; .2 g/100g; g/100g; 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
ROROBELL WAWA Kids Tooth Natural Green Grape Flavor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.22 g/100g
HYDRATED SILICA13 g/100g
.ALPHA.-TOCOPHEROL ACETATE.2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup
Y6O7T4G8P9Internal UNII lookup
9E8X80D2L0Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
586b499d-23bf-0116-e063-6394a90aa7d4Available on FDA.report

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROROBELL WAWA Kids Tooth Natural Green Grape FlavorHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL586b499d-23bf-0116-e063-6394a90aa7d42026-08-06WarningsExact identifier
ndc (package): 81275-015-02
ndc (product): 81275-015
ndc11 (package): 81275001502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81275-015-02812750015021 TUBE in 1 CARTON (81275-015-02) / 60 g in 1 TUBE (81275-015-01) 1 tube2026-08-01NoNoCurrent