Lornamead

Product NDC: 62721-0470
11-digit product format: 627210470
Labeler code: 62721
Product ID: 62721-0470_3bdd868d-4c10-0942-e063-6294a90a6d15
Type: HUMAN OTC DRUG
Nonproprietary name: Fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Lornamead Products
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-12-01
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 5; .15 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	62721-0470	62721-0470-9	D	Discontinued by firm		2026-08-10

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	62721-0470-9	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	62721-0470-9	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	62721-0470-9	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	62721-0470-9	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	62721-0470-9	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	62721-0470-9	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	62721-0470-9	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	62721-0470-9	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	62721-0470-9	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	62721-0470-9	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	62721-0470-9	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	62721-0470-9	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62721-0470-9	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62721-0470-9	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62721-0470-9	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62721-0470-9	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62721-0470-9	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62721-0470-9	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	62721-0470-9	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lornamead
Brand name suffix: Natural White
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	5 g/100g
POTASSIUM NITRATE	.15 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
9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2023-06-13	5010570 Natural White Extreme Sensitive Whitening
2023-06-13	5010570 Natural White Extreme Sensitive Whitening
2020-01-31	5010570 Natural White Extreme Sensitive Whitening
2020-01-31	5010570 Natural White Extreme Sensitive Whitening

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62721-0470-2	LornameadNatural White	128 g in 1 TUBE	PASTE, DENTIFRICE	128	6
62721-0470-3	LornameadNatural White	96.4 g in 1 TUBE	PASTE, DENTIFRICE	96.4	6
62721-0470-7	LornameadNatural White	1 in 1 CARTON	PASTE, DENTIFRICE	1	6
62721-0470-9	LornameadNatural White	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	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
POLYETHYLENE GLYCOL 600	INACTIVE INGREDIENT	NL4J9F21N9	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
SODIUM TRIPOLYPHOSPHATE	INACTIVE INGREDIENT	5HK03SA80J	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62721-0470	LORNAMEAD NATURAL WHITE (FLUORIDE) PASTE, DENTIFRICE [LORNAMEAD]	4	Current NDC, Legacy NDC, 4 package rows	20250119_9d7d08d7-8ca4-4b05-8b74-3bfa372b1608.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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022 ndc (product): 62721-0470
Made by Dentists Enamel 10 Fluoride Anticavity	POTASSIUM NITRATE, SODIUM FLUORIDE	Made By Dentists Inc	3c62eab1-0cb6-4bdf-bfd4-c5afe734d036	2026-07-24	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	Warnings	Exact identifier application number: M022
ABC Sore Throat Menthol Flavor	PHENOL	AMERISOURCE BERGEN	9d9baf58-4790-4ff4-a462-5eb70c0e80c5	2026-07-13	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	P & L Development, LLC	350b5f64-d152-40cb-b22f-98541f0e1b0a	2026-07-09	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	561a75c2-a40c-ba7c-e063-6294a90aa119	2026-07-08	Warnings	Exact identifier application number: M022
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-07-06	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-07-03	Warnings	Exact identifier application number: M022
Dental system starter kit	US CONVENIENCE KIT (718907)	Dyson Technology Limited	5355b79b-711f-1a4a-e063-6394a90afc4b	2026-06-30	Warnings	Exact identifier application number: M022
Anticavity and sensitive peppermint	907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT	Dyson Technology Limited	5332ab71-d994-39cf-e063-6294a90a0d98	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55820ff9-7b4b-2bce-e063-6394a90a8b43	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55806cb8-cf92-c4e5-e063-6394a90aaa2d	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	5581d8e5-4105-e9da-e063-6394a90a316e	2026-06-30	Warnings	Exact identifier application number: M022
Corinz	CETYLPYRIDINIUM CHLORIDE	Sage Products, LLC	685b6023-89c4-417e-af2d-52e831855da1	2026-06-29	Warnings	Exact identifier application number: M022
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	Warnings	Exact identifier application number: M022

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

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	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62721-0470-2	62721047002	128 g in 1 TUBE	128 g				Historical
62721-0470-3	62721047003	96.4 g in 1 TUBE	96.4 g				Historical
62721-0470-7	62721047007	1 TUBE in 1 CARTON (62721-0470-7) / 96.4 g in 1 TUBE (62721-0470-3)	1 tube	2023-06-12	No	No	Current
62721-0470-9	62721047009	1 in 1 CARTON					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
5010570 Natural White Extreme Sensitive Whitening	Lornamead Products	2026-07-29	HUMAN OTC DRUG LABEL	7