Sheffield Pain Relief

Product NDC: 11527-062
11-digit product format: 115270062
Labeler code: 11527
Product ID: 11527-062_2782a87e-5b11-4ee5-8649-3f31a52d4bda
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE
Dosage form: GEL
Route: ORAL
Labeler: Sheffield Pharmaceuticals LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2006-01-30
Substance: BENZOCAINE
Active strength: 200 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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	11527-062	11527-062-55	D	Discontinued by firm		2026-10-12

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`

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: Sheffield Pain Relief
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	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
e21abfdd-373d-42af-9535-fe1571382a65	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11527-062-47	Sheffield Pain Relief	1 in 1 CARTON	GEL	1	6
11527-062-47	Sheffield Pain Relief	9.35 g in 1 TUBE	GEL	9.35	6
11527-062-55	Sheffield Pain Relief	1 in 1 CARTON	GEL	1	6
11527-062-55	Sheffield Pain Relief	9.35 g in 1 TUBE	GEL	9.35	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11527-062-47	GM - Gram	11527-062	04573aa0-a338-4a29-a30b-35c4d928e852	1	2024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1
Sorbic Acid	INACTIVE INGREDIENT	X045WJ989B	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11527-062	SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [SHEFFIELD PHARMACEUTICALS LLC]	6	Current NDC, Legacy NDC, 4 package rows	20250221_e21abfdd-373d-42af-9535-fe1571382a65.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 12 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitive Whitening Tooth-paste	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	c25b6a95-e604-48e3-bc55-595969d1ce9b	2025-12-23	Warnings	Exact identifier application number: M022
parodontax Active Gum Repair	STANNOUS FLUORIDE	Haleon US Holdings LLC	b51ccdd9-c0af-4caa-ad97-ad1d1423b76b	2025-12-22	Warnings	Exact identifier application number: M022
parodontax Complete Protection	STANNOUS FLUORIDE	Haleon US Holdings LLC	59bb84d6-6fd3-4586-bccf-7dc45cbbb39c	2025-12-22	Warnings	Exact identifier application number: M022
parodontax Complete Protection	STANNOUS FLUORIDE	Haleon US Holdings LLC	f6912712-ce9b-44aa-8953-b9a8d420f458	2025-12-22	Warnings	Exact identifier application number: M022
parodontax Active Gum Repair Whitening	STANNOUS FLUORIDE	Haleon US Holdings LLC	817e804c-e55e-4d77-9ab9-ff54ae794725	2025-12-22	Warnings	Exact identifier application number: M022
parodontax Active Gum Repair Breath Freshener	STANNOUS FLUORIDE	Haleon US Holdings LLC	addcb1e2-24b9-4367-adf3-6806e2439a80	2025-12-22	Warnings	Exact identifier application number: M022
parodontax	STANNOUS FLUORIDE	Haleon US Holdings LLC	0f07aa1a-97be-44af-92d8-a10777e24e0a	2025-12-22	Warnings	Exact identifier application number: M022
R B one	PHOSPHATIDYLSERINE, ZINC OXIDE	NPG Bio Pharmaceuticals Co.,Ltd.	410c40fd-cf94-0301-e063-6294a90ae2de	2025-12-18	Warnings	Exact identifier application number: M022
Dem Zero	PHOSPHATIDYLSERINE, MAGNESIUM OXIDE	NPG Bio Pharmaceuticals Co.,Ltd.	411f1a0f-ed02-cc78-e063-6394a90a0aec	2025-12-18	Warnings	Exact identifier application number: M022
Res B one	PHOSPHATIDYLSERINE, ZINC OXIDE	NPG Bio Pharmaceuticals Co.,Ltd.	21469f58-1d70-774f-e063-6294a90af039	2025-12-18	Warnings	Exact identifier application number: M022
Alzh L	PHOSPHATIDYLSERINE, MAGNESIUM OXIDE	NPG Bio Pharmaceuticals Co.,Ltd.	41056de0-aaa2-01bb-e063-6394a90af7b8	2025-12-18	Warnings	Exact identifier application number: M022
Lemon	GLYCERIN	TwinMed LLC	fc88eec0-c66c-5d6d-e053-6294a90a13d2	2025-12-18	Warnings	Exact identifier application number: M022
CloSYS	HYDROGEN PEROXIDE	Rowpar Pharmaceuticals, Inc.	299fc7b1-af6d-4bf9-810f-d35283423fe2	2025-12-17	Warnings	Exact identifier application number: M022
Ipana 20% Benzocaine Topical	BENZOCAINE	Maxill Inc.	c13761e0-d45d-4e0f-ac41-428e005f96bb	2025-12-17	Warnings	Exact identifier application number: M022
Ipana 20% Benzocaine Topical	BENZOCAINE	Maxill Inc.	6dca566b-cb6a-43c4-b6e2-f2bad77fb932	2025-12-17	Warnings	Exact identifier application number: M022
Ipana 20% Benzocaine Topical	BENZOCAINE	Maxill Inc.	f36bb9bd-e9bc-4f35-a388-e0ffadbce6ab	2025-12-17	Warnings	Exact identifier application number: M022
Ipana 20% Benzocaine Topical	BENZOCAINE	Maxill Inc.	7ede08e5-2dfe-4183-905d-28d1cea42407	2025-12-17	Warnings	Exact identifier application number: M022
Ipana 20% Benzocaine Topical	BENZOCAINE	Maxill Inc.	9de36e4f-f966-4a58-b4bf-9ac3b86b3f09	2025-12-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	CVS PHARMACY, INC	3b0ad9ac-4920-45a7-b336-dfa7f8d9bdb2	2025-12-17	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	9128d59c-6fa9-4358-865a-802257a9bd25	2025-12-16	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	e21abfdd-373d-42af-9535-fe1571382a65	6
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	e21abfdd-373d-42af-9535-fe1571382a65	6
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	e21abfdd-373d-42af-9535-fe1571382a65	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11527-062-47	11527006247	1 TUBE in 1 CARTON (11527-062-47) / 9.35 g in 1 TUBE	1 tube	2006-01-30		No	No	Current
11527-062-55	11527006255	1 TUBE in 1 CARTON (11527-062-55) > 9.35 g in 1 TUBE	1 tube	2006-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sheffield Pain Relief - Sheffield Pharmaceuticals LLC	Sheffield Pharmaceuticals LLC	2025-02-19	HUMAN OTC DRUG LABEL	6