Cool sense Care Plus

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: Cool sense Care Plus
Generic name: SODIUM FLUORIDE
Manufacturer: DOCSMEDI Co., Ltd.
Product type: HUMAN OTC DRUG
SPL set ID: ea18ac56-4ef1-4bf0-8c26-6885183fd684
SPL ID: 2c472d51-102b-14ef-e063-6394a90a02fd
Version: 5
Effective date: 2025-01-22
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:45:24

Harmonized routes table
Harmonized routes
DENTAL

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 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M021	openfda.application_number
brand name		Cool sense Care Plus	openfda.brand_name
generic name		SODIUM FLUORIDE	openfda.generic_name
manufacturer name		DOCSMEDI Co., Ltd.	openfda.manufacturer_name
ndc	package	76670-0013-1	openfda.package_ndc
ndc	product	76670-0013	openfda.product_ndc
ndc11	package	76670001301	derived:openfda.package_ndc
rxcui		240698	openfda.rxcui
spl id		2c472d51-102b-14ef-e063-6394a90a02fd	id
spl set id		ea18ac56-4ef1-4bf0-8c26-6885183fd684	set_id
unii		8ZYQ1474W7	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 ■ Stop using this product and consult a dentist if irritation occurs. ■ For children under 6 years of age, use only a small amount under adult supervision to prevent sucking or swallowing. ■ If a child under 6 swallows a large amount, seek medical help or consult a 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.