ROROBELL WAWA Gum Care Tooth

Product NDC: 81275-011
Requested package NDC: 81275-011-02
11-digit product format: 812750011
Labeler code: 81275
Product ID: 81275-011_582204ef-b785-0d95-e063-6394a90a38d2
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: HYDRATED SILICA; SODIUM FLUORIDE; .ALPHA.-TOCOPHEROL ACETATE
Active strength: 19; .32; .05 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 Gum Care Tooth
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDRATED SILICA	19 g/100g
SODIUM FLUORIDE	.32 g/100g
.ALPHA.-TOCOPHEROL ACETATE	.05 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
Y6O7T4G8P9	Internal UNII lookup
8ZYQ1474W7	Internal UNII lookup
9E8X80D2L0	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
582204ef-b784-0d95-e063-6394a90a38d2	Available 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ROROBELL WAWA Gum Care Tooth	HYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE	ROROBELL	582204ef-b784-0d95-e063-6394a90a38d2	2026-08-03	Warnings	Exact identifier ndc (package): 81275-011-02 ndc (product): 81275-011 ndc11 (package): 81275001102

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y6O7T4G8P9	HYDRATED SILICA	1343-98-2	HYDRATED SILICA
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE
9E8X80D2L0	.ALPHA.-TOCOPHEROL ACETATE	7695-91-2	.ALPHA.-TOCOPHEROL ACETATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81275-011-02	81275001102	1 TUBE in 1 CARTON (81275-011-02) / 100 g in 1 TUBE (81275-011-01)	1 tube	2026-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROROBELL WAWA Gum Care Tooth - ROROBELL \| DONG IL PHARMS CO., LTD.	ROROBELL \| DONG IL PHARMS CO., LTD.	2026-08-03	HUMAN OTC DRUG LABEL	1