ROROBELL WAWA Whitening Tooth

Product NDC: 81275-013
Requested package NDC: 81275-013-02
11-digit product format: 812750013
Labeler code: 81275
Product ID: 81275-013_58336a24-e7ee-269d-e063-6294a90a5461
Type: HUMAN OTC DRUG
Nonproprietary name: Silica, Hydrogen Peroxide, Tocopheryl Acetate
Dosage form: PASTE, DENTIFRICE
Route: ORAL
Labeler: ROROBELL
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-08-01
Substance: HYDROGEN PEROXIDE; SILICA; .ALPHA.-TOCOPHEROL ACETATE
Active strength: 2.14; 7; .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 Whitening Tooth
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROGEN PEROXIDE	2.14 g/100g
SILICA	7 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
Identifier	FDA.report destination
BBX060AN9V	Internal UNII lookup
ETJ7Z6XBU4	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
58336a0d-49dd-ef13-e063-6394a90a38c1	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 Whitening Tooth	SILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATE	ROROBELL	58336a0d-49dd-ef13-e063-6394a90a38c1	2026-08-04	Warnings	Exact identifier ndc (package): 81275-013-02 ndc (product): 81275-013 ndc11 (package): 81275001302

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BBX060AN9V	HYDROGEN PEROXIDE	7722-84-1	HYDROGEN PEROXIDE
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
81275-013-02	81275001302	1 TUBE in 1 CARTON (81275-013-02) / 80 g in 1 TUBE (81275-013-01)	1 tube	2026-08-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ROROBELL WAWA Whitening Tooth - ROROBELL \| DONG IL PHARMS CO., LTD.	ROROBELL \| DONG IL PHARMS CO., LTD.	2026-08-04	HUMAN OTC DRUG LABEL	1