FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11527-06211527-062-55DDiscontinued by firm2026-10-15

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…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
IngredientStrength
BENZOCAINE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238910Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e21abfdd-373d-42af-9535-fe1571382a65Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11527-062-47Sheffield Pain Relief1 in 1 CARTONGEL16
11527-062-47Sheffield Pain Relief9.35 g in 1 TUBEGEL9.356
11527-062-55Sheffield Pain Relief1 in 1 CARTONGEL16
11527-062-55Sheffield Pain Relief9.35 g in 1 TUBEGEL9.356

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11527-062-47GM - Gram11527-06204573aa0-a338-4a29-a30b-35c4d928e85212024-07-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ASHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQSHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PSHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYSHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1
Sorbic AcidINACTIVE INGREDIENTX045WJ989BSHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [FARIA LLC DBA SHEFFIELD PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11527-062SHEFFIELD PAIN RELIEF (BENZOCAINE) GEL [SHEFFIELD PHARMACEUTICALS LLC]6Current NDC, Legacy NDC, 4 package rows20250221_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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNe21abfdd-373d-42af-9535-fe1571382a656
238910benzocaine 0.2 MG/MG Oral GelSCDe21abfdd-373d-42af-9535-fe1571382a656
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYe21abfdd-373d-42af-9535-fe1571382a656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11527-062-47115270062471 TUBE in 1 CARTON (11527-062-47) / 9.35 g in 1 TUBE1 tube2006-01-30NoNoCurrent
11527-062-55115270062551 TUBE in 1 CARTON (11527-062-55) > 9.35 g in 1 TUBE1 tube2006-01-300000-00-00NoNoCurrent