Lornamead

Product NDC: 62721-0470
11-digit product format: 627210470
Labeler code: 62721
Product ID: 62721-0470_57c60feb-2b08-cb25-e063-6294a90a5d92
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: 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

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		2026-10-05

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…`

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: Lornamead
Brand name suffix: Natural White
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
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
CrystLCare Regeneration Plus	POTASSIUM NITRATE, SODIUM FLUORIDE	GreenMark Biomedical Inc.	4f86d0a0-d73e-5605-e063-6394a90adb38	2026-09-14	Warnings	Exact identifier application number: M022
Opalescence Whitening Sensitivity Relief	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	44e94663-895b-67da-e063-6394a90a5fe6	2026-09-09	Warnings	Exact identifier application number: M022
Opalescence Sensitivity Relief Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	b5176a84-76a3-4ad0-a2e2-4997a12da9a5	2026-09-09	Warnings	Exact identifier application number: M022
Opal by Opalescence Sensitivity	POTASSIUM NITRATE AND SODIUM FLUORIDE	Ultradent Products, Inc.	5ffc0d14-0290-47bb-90e5-90a25a5acc28	2026-09-09	Warnings	Exact identifier application number: M022
Saline	NASAL	Raritan Pharmaceuiticals Inc	4b178e4e-a10f-4b75-8140-1f7548e203ad	2026-09-09	Warnings	Exact identifier application number: M022
SORE THROAT	PHENOL	Raritan Pharmaceuticals Inc	43ce374a-824c-4034-bf04-c351b4d8015b	2026-09-08	Warnings	Exact identifier application number: M022
Colgate Optic White Stain Fighter Sens Relief	SODIUM FLUORIDE	Colgate-Palmolive Company	6ec2fff7-df44-4302-be2d-97946c6cd66a	2026-09-08	Warnings	Exact identifier application number: M022
DRx Choice Sore Throat Menthol Flavor	PHENOL	RARITAN PHARMACEUTICALS INC	e3269b12-5c05-45a6-81f2-65d9f016c3aa	2026-09-08	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	AmerisourceBergen (Good Neighbor Pharmacy) 46122	0733015b-e81a-4a62-82ad-dacaf3f163cb	2026-09-02	Warnings	Exact identifier application number: M022
KROGER Saline	NASAL	KROGER COMPANY	c84b242b-f46e-4ea8-a3c1-109a47644646	2026-09-02	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	ceb125d9-8c1b-498c-b0f0-f18756ede442	2026-09-01	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1c82b4-02b3-d456-e063-6294a90a16bb	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum PM Cream	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1cdaf4-3388-280c-e063-6294a90ac70f	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT	HEXYLRESORCINOL	Reckitt Benckiser LLC	91cd2964-5d83-4e40-bc18-e3e5462f454a	2026-08-31	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	HEXYLRESORCINOL	Reckitt Benckiser LLC	4c150222-06ea-4fcf-967f-84e19846bd66	2026-08-31	Warnings	Exact identifier application number: M022
Orajel 4X Medicated Toothache and Gum	BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	5a1b4133-0eac-2f8f-e063-6394a90af8f6	2026-08-28	Warnings	Exact identifier application number: M022
LUDENS SUGAR FREE WILD CHERRY THROAT	PECTIN	Prestige Brands Holdings, Inc.	274fc80c-e5b2-41c7-a119-287d6e8a2258	2026-08-28	Warnings	Exact identifier application number: M022
Medline Peroxi Fresh Mouthwash	HYDROGEN PEROXIDE	Medline Industries, LP	ec7a9240-6c66-4471-b8b6-776e08a14fbc	2026-08-27	Warnings	Exact identifier application number: M022
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Tumeez Organic Apple	CALCIUM CARBONATE	BFY LLC	f561685a-5260-59c6-e053-2a95a90ae206	2026-08-25	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	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