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: 1b6618ea-6533-41d7-be2c-13bb9e108dc5
SPL ID: 47e54e5e-4bd7-00ce-e063-6394a90a99e8
Version: 6
Effective date: 2026-01-08
Source export date: 2026-09-28
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:19:37

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	41520-415-02	openfda.package_ndc
ndc	package	41520-415-09	openfda.package_ndc
ndc	product	41520-415	openfda.product_ndc
ndc11	package	41520041509	derived:openfda.package_ndc
ndc11	package	41520041502	derived:openfda.package_ndc
rxcui		1038929	openfda.rxcui
spl id		47e54e5e-4bd7-00ce-e063-6394a90a99e8	id
spl set id		1b6618ea-6533-41d7-be2c-13bb9e108dc5	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

When using this product do not use for 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.