Care One Maximum Strength

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: Care One Maximum Strength
Generic name: FLUORIDE
Manufacturer: American Sales
Product type: HUMAN OTC DRUG
SPL set ID: 24715cc7-cf02-4ea0-a491-2a111ad3660e
SPL ID: 439584ef-226b-fedb-e063-6394a90aaffd
Version: 10
Effective date: 2025-11-14
Source export date: 2026-11-06
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/b0d9ca61dc485ebaf55e14a76d7d677668e40ef1e1978cdbcc4d73d58eba0b99/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run: 20261108T063105Z
Imported at: 2026-11-08 07:46:11

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M022	openfda.application_number
brand name		Care One Maximum Strength	openfda.brand_name
generic name		FLUORIDE	openfda.generic_name
manufacturer name		American Sales	openfda.manufacturer_name
ndc	package	41520-582-19	openfda.package_ndc
ndc	package	41520-582-12	openfda.package_ndc
ndc	product	41520-582	openfda.product_ndc
ndc11	package	41520058212	derived:openfda.package_ndc
ndc11	package	41520058219	derived:openfda.package_ndc
rxcui		1038929	openfda.rxcui
spl id		439584ef-226b-fedb-e063-6394a90aaffd	id
spl set id		24715cc7-cf02-4ea0-a491-2a111ad3660e	set_id
unii		8ZYQ1474W7	openfda.unii
unii		RU45X2JN0Z	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 When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. See your dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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