Sensitive Whitening Tooth-paste

Product NDC: 79481-0008
11-digit product format: 794810008
Labeler code: 79481
Product ID: 79481-0008_e9579105-80a5-440e-8da2-b31b65542f32
Type: HUMAN OTC DRUG
Nonproprietary name: Potassium nitrate, Sodium fluoride
Dosage form: PASTE, DENTIFRICE
Route: DENTAL
Labeler: Meijer, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-12-24
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 2.43 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 18 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 product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79481-0008-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79481-0008-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79481-0008-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79481-0008-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79481-0008-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79481-0008-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79481-0008-1	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	79481-0008-1	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	79481-0008-1	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: Sensitive Whitening Tooth-paste
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	2.43 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038800	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
c25b6a95-e604-48e3-bc55-595969d1ce9b	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
79481-0008-1	2025-12-24	C162847	48780-1	2cef2736-ab49-d83d-e063-dadaa90ab31f	meijer ® sensitive toothpaste EXTRA WHITENING
79481-0008-1	2025-01-30	C162847	48780-1	2cef2736-ab49-d83d-e063-dadaa90ab31f	meijer ® sensitive toothpaste EXTRA WHITENING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
79481-0008-1	Sensitive Whitening Tooth-paste	113 g in 1 TUBE	PASTE, DENTIFRICE	113		4
79481-0008-1	Sensitive Whitening Tooth-paste	1 in 1 BOX	PASTE, DENTIFRICE	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79481-0008	SENSITIVE WHITENING TOOTH-PASTE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [MEIJER, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230112_c25b6a95-e604-48e3-bc55-595969d1ce9b.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 34 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Cherry	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	a0e145c8-6b08-40be-ae4f-5678c4a78b1e	2024-10-30	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33b-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043bfbc3-c33a-78b7-e063-6294a90a1a5a	2024-10-29	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043a3cb4-f560-0ffd-e063-6394a90a2ff6	2024-10-29	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Mint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	be57ca56-834f-4170-a407-f193484d8b0a	2024-10-29	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	817c0dad-d109-428e-adb5-3354604acc94	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals LLC	0dd15227-6603-42ac-9a5f-f2dc49e0382a	2024-10-28	Warnings, Adverse reactions	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	0605d5d6-82bd-415e-b5cb-e273f934a4a7	2024-10-28	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic Liquid	BENZOCAINE	Beutlich Pharmaceuticals, LLC	f70fa3fc-cd65-4a80-9efd-129e98fd3998	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Menthol	PHENOL	Chain Drug Consortium	af661ef0-cdc3-4146-8ae5-59795aa49650	2024-10-28	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Chain Drug Consortium	a9cf9829-4b70-44fa-9719-240b65c06724	2024-10-28	Warnings	Exact identifier application number: M022
Ear Wax Removal Aid Drops	CARBAMIDE PEROXIDE	PHARMACY VALUE ALLIANCE, LLC	85ae80c1-2bc2-4c90-9559-63510d03e739	2024-10-28	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
1038800	potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.14 % - 0.15 % ) Toothpaste	PSN	c25b6a95-e604-48e3-bc55-595969d1ce9b	4
1038800	potassium nitrate 0.05 MG/MG / sodium fluoride 0.00243 MG/MG Toothpaste	SCD	c25b6a95-e604-48e3-bc55-595969d1ce9b	4
1038800	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	c25b6a95-e604-48e3-bc55-595969d1ce9b	4
1038800	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.00243 MG/MG Toothpaste	SY	c25b6a95-e604-48e3-bc55-595969d1ce9b	4
1038800	potassium nitrate 5 % / sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	c25b6a95-e604-48e3-bc55-595969d1ce9b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79481-0008-1	79481000801	1 TUBE in 1 BOX (79481-0008-1) / 113 g in 1 TUBE	1 tube	2020-12-24	0000-00-00	No	No	Current