Rorobell WaWa Tooth

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Rorobell WaWa Tooth
Generic name: SODIUM MONOFLUOROPHOSPHATE
Manufacturer: ROROBELL
Product type: HUMAN OTC DRUG
SPL set ID: 93113481-ad9d-4be0-a7b7-a72c8726127d
SPL ID: 5821995e-620b-385b-e063-6294a90a5c97
Version: 5
Effective date: 2026-08-03
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:41:22

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Rorobell WaWa Tooth	openfda.brand_name
generic name		SODIUM MONOFLUOROPHOSPHATE	openfda.generic_name
manufacturer name		ROROBELL	openfda.manufacturer_name
ndc	package	81275-010-01	openfda.package_ndc
ndc	package	81275-010-02	openfda.package_ndc
ndc	product	81275-010	openfda.product_ndc
ndc11	package	81275001001	derived:openfda.package_ndc
ndc11	package	81275001002	derived:openfda.package_ndc
rxcui		2471311	openfda.rxcui
spl id		5821995e-620b-385b-e063-6294a90a5c97	id
spl set id		93113481-ad9d-4be0-a7b7-a72c8726127d	set_id
unii		C810JCZ56Q	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS ■ Contains 950 ppm of fluoride. ■ Do not swallow. Rinse your mouth thoroughly after use. ■ If you experience any problems with your gums or mouth during use, discontinue use and consult a physician or dentist. ■ Children under 6 years of age should use a small amount of toothpaste under adult supervision to minimize swallowing. ■ If a child under 6 years of age accidentally swallows a large a mount, consult a physician or dentist immediately. ■ Keep out of reach of children under 6 years of age.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.