Care One

Product NDC: 41520-415
11-digit product format: 415200415
Labeler code: 41520
Product ID: 41520-415_47e54e5e-4bd7-00ce-e063-6394a90a99e8
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: American Sales
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-01-20
Substance: SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength: .15; 5 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	41520-415-09	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	41520-415-09	`e2bbac7714bc…`	`27bdfed8d636…`

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: Care One
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.15 g/100g
POTASSIUM NITRATE	5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup
RU45X2JN0Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1b6618ea-6533-41d7-be2c-13bb9e108dc5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-03-10	5820110 Care One Max Str Sens Mint
2022-03-10	5820110 Care One Max Str Sens Mint
2020-09-27	5820110 Care One Max Str Sens Mint
2020-09-27	5820110 Care One Max Str Sens Mint
2020-09-25	5820110 Care One Max Str Sens Mint
2020-09-25	5820110 Care One Max Str Sens Mint
2020-07-22	5820110 Care One Max Str Sens Mint
2020-07-22	5820110 Care One Max Str Sens Mint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-415-02	Care OneMaximum Strength	113 g in 1 TUBE	PASTE, DENTIFRICE	113		6
41520-415-09	Care OneMaximum Strength	1 in 1 CARTON	PASTE, DENTIFRICE	1		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-415	CARE ONE MAXIMUM STRENGTH (FLUORIDE) PASTE, DENTIFRICE [AMERICAN SALES]	5	Current NDC, Legacy NDC, 2 package rows	20250119_1b6618ea-6533-41d7-be2c-13bb9e108dc5.zip

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 38 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moon Charcoal Whitening Anticavity	SODIUM FLUORIDE	Moon Oral Care, LLC	0c55f7b3-fea1-58f3-e063-6394a90a3bde	2023-12-12	Warnings	Exact identifier application number: M022
ORCA Complete Menthol Pain Reliever	MENTHOL	ORCA Products, LLC	99990e27-d66b-4d61-97f2-6a76066eb8b8	2023-12-08	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	0070858b-e02e-431f-a7c2-313fef01791b	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	d1802f08-80cb-41dd-b34d-9c576b101ddb	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	80182c43-100f-4b15-a07e-819599ab9562	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c19e6426-8f1e-47b3-a3a6-551a5bec6cd9	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1f8431bb-f33c-4fd8-9472-9b59ffb5f18e	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	1163d248-d648-443e-bed0-ccb7fd26ba63	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	88caabe2-a096-44d0-98d3-afad1935c012	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	c1b02a2f-db1f-44f0-a74a-d02c085c5bd7	2023-12-07	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	39081585-fe6a-4ba1-93f8-d92d26fe75bc	2023-12-07	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	d7c69357-795c-03d8-e053-2a95a90a03a6	2023-12-06	Warnings	Exact identifier application number: M022
Dr. Sheffield Sensitive Care	SENSITIVE TOOTH PASTE	Sheffield Pharmaceuticals LLC	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	2023-11-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f3bf106c-5320-ced2-e053-2a95a90a71ac	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b517321-25ed-2676-e063-6294a90ab4c9	2023-11-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0b51b67c-03ac-5730-e063-6394a90a5060	2023-11-29	Warnings	Exact identifier application number: M022
Pearl White	POTASSIUM NITRATE, SODIUM FLUORIDE	Beyond International Inc.	51c79544-9536-5863-e054-00144ff8d46c	2023-11-28	Warnings	Exact identifier application number: M022
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE	POTASSIUM NITRATE AND SODIUM FLUORIDE	Universal Distribution Center LLC	fcf59439-7e06-4129-a89f-cdeecdf8d488	2023-11-17	Warnings	Exact identifier application number: M022
PerioRestore	HYDROGEN PEROXIDE	DEN-MAT HOLDINGS, LLC.	97a07c36-1af8-a636-e053-2a95a90ad6db	2023-11-13	Warnings	Exact identifier application number: M022
Wild Horse 777 Oral	PHENOL	Wild Horse 777, Inc.	b0b517bb-969f-0c65-e053-2995a90a48b1	2023-11-10	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	1b6618ea-6533-41d7-be2c-13bb9e108dc5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41520-415-02	41520041502	113 g in 1 TUBE	113 g					Historical
41520-415-09	41520041509	1 TUBE in 1 CARTON (41520-415-09) / 113 g in 1 TUBE (41520-415-02)	1 tube	2012-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5820110 Care One Max Str Sens Mint	American Sales \| Lornamead \| Lornamead Products	2026-01-08	HUMAN OTC DRUG LABEL	6