Dr. Sheffield Sensitive Care

Product NDC: 11527-420
11-digit product format: 115270420
Labeler code: 11527
Product ID: 11527-420_1dbaf50f-34ac-4468-80c8-49e58ee2f07d
Type: HUMAN OTC DRUG
Nonproprietary name: Sensitive Tooth Paste
Dosage form: PASTE, DENTIFRICE
Route: ORAL
Labeler: Sheffield Pharmaceuticals LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-05-15
Substance: POTASSIUM NITRATE
Active strength: 50 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Dr. Sheffield Sensitive Care
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
312544	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
702a0dec-64cf-4834-8d80-f3d4f0c08a3a	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11527-420-45	2020-04-21	C162847	48780-1	9d75b9d0-ed04-f424-e053-dadaa90a57ce	Dr. Sheffield Sensitive Care
11527-420-45	2020-01-31	C162847	48780-1	9d75b9d0-ed04-f424-e053-dadaa90a57ce	Dr. Sheffield Sensitive Care

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11527-420-45	Dr. Sheffield Sensitive Care	1 in 1 CARTON	PASTE, DENTIFRICE	1		3
11527-420-45	Dr. Sheffield Sensitive Care	141 g in 1 TUBE	PASTE, DENTIFRICE	141		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-420	DR. SHEFFIELD SENSITIVE CARE (SENSITIVE TOOTH PASTE) PASTE, DENTIFRICE [SHEFFIELD PHARMACEUTICALS LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231201_702a0dec-64cf-4834-8d80-f3d4f0c08a3a.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 33 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOL RELIEF LEMON FROST ORAL ANESTHETIC	MENTHOL	Ricola Ag	908f5ce5-94a4-4c35-ae7a-b308ea37fa08	2024-12-05	Warnings	Exact identifier application number: M022
ORGANIC PEPPERMINT HERB THROAT DROPS	MENTHOL	Ricola Ag	a6657ecf-e74a-4912-a68c-73abc456f9e2	2024-12-05	Warnings	Exact identifier application number: M022
NATURAL LEMON MINT HERB THROAT DROPS	MENTHOL	Ricola Ag	67373cf1-e8c3-4db2-98e1-c88d25a76209	2024-12-05	Warnings	Exact identifier application number: M022
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola Ag	586b2a46-2673-4f27-a62a-2d48a9b520ab	2024-12-05	Warnings	Exact identifier application number: M022
BERRY MEDLEY THROAT DROPS	MENTHOL	Ricola Ag	a2bdd035-4678-4cff-b24f-8e2f06acad96	2024-12-05	Warnings	Exact identifier application number: M022
Orajel Toothache Rinse	BENZYL ALCOHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	41709710-5392-3119-e054-00144ff88e88	2024-11-27	Warnings	Exact identifier application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore Rinse	HYDROGEN PEROXIDE, MENTHOL	Church & Dwight Co., Inc.	99d47d6a-fa2e-d5ee-e053-2995a90aa11d	2024-11-27	Warnings	Exact identifier application number: M022
Orajel 2x Gum Pain Alcohol-Free	MENTHOL AND HYDROGEN PEROXIDE	Church & Dwight Co., Inc.	adf37010-922c-4441-93d6-1e1a95025e90	2024-11-27	Warnings	Exact identifier application number: M022
Maximum Strength Cold Sore Treatment	CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM	Meijer Distribution Inc	9220772c-b3b7-4855-e053-2a95a90a94f6	2024-11-27	Warnings	Exact identifier application number: M022
Peroxyl Mouth Sore Mild Mint	HYDROGEN PEROXIDE	Colgate Oral Pharmaceuticals Inc.	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	2024-11-25	Warnings	Exact identifier application number: M022
NICE SORE THROAT Spearmint	PHENOL	Leosons Overseas Corp	5fc68f04-ec15-11c0-e053-2a91aa0a1952	2024-11-20	Warnings	Exact identifier application number: M022
TANAC Oral Pain Reliever	BENZOCAINE	Leosons Overseas Corp	81cc61fa-31a7-2214-e053-2a91aa0ae46a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Honey Lemon	PHENOL	Leosons Overseas Corp	601aea98-e6ab-de6f-e053-2a91aa0a824a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Cherry	PHENOL	Leosons Overseas Corp	5f21694c-d1c9-0e64-e053-2a91aa0a0ff0	2024-11-15	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL	Safeway, Inc.	f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d	2024-11-14	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry	PHENOL	Best Choice (Valu Merchandisers Company)	c0a47d59-3e15-453d-97a7-d626e8650862	2024-11-14	Warnings	Exact identifier application number: M022
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312544	potassium nitrate 5 % Toothpaste	PSN	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	3
312544	potassium nitrate 0.05 MG/MG Toothpaste	SCD	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	3
312544	K+ nitrate 0.05 MG/MG Toothpaste	SY	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	3
312544	Pot nitrate 0.05 MG/MG Toothpaste	SY	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	3
312544	potassium nitrate 5 % Toothpaste	SY	702a0dec-64cf-4834-8d80-f3d4f0c08a3a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-420-45	11527042045	1 TUBE in 1 CARTON (11527-420-45) / 141 g in 1 TUBE	1 tube	2017-05-15	0000-00-00	No	No	Current