FDA.reportPublic FDA data

Oral Pain Relief

Product NDC
52000-060
11-digit product format
520000060
Labeler code
52000
Product ID
52000-060_de98c97f-7c6f-4676-bf8e-797f3f24c598
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-05
Substance
BENZOCAINE; BENZALKONIUM CHLORIDE
Active strength
.2; .01 g/g; g/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52000-060IInactivated by FDA2026-10-23
excluded packagepackage52000-06052000-060-01IInactivated by FDA2026-10-23

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52000-060-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52000-060-01f5e01cc5f278…a2eaf40c39c3…

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
Oral Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE.2 g/g
BENZALKONIUM CHLORIDE.01 g/g

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-060-012025-07-29C16284748780-13b156c62-2e7e-fb37-e063-e6dba90a4e07Oral Pain Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-060-01Oral Pain Relief14 g in 1 TUBEGEL144
52000-060-01Oral Pain Relief1 in 1 CARTONGEL14
52000-060-02Oral Pain Relief14 g in 1 TUBEGEL143
52000-060-02Oral Pain Relief1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-060ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]4Current NDC, Legacy NDC, 2 package rows20241212_baf0cf27-052e-4367-9a6e-75038b97a051.zip
52000-060ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 2 package rows20241218_18520f9b-4d35-1e9c-e063-6294a90aaa39.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 25 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.d923fa75-f556-45e3-9f52-39a62e89984b2025-01-09WarningsExact identifier
application number: M022
Candee Caine Topical AnestheticBENZOCAINEAmerican Medical & Hospital Supply Co., Inc.cd3ede8c-2c77-4d81-8dff-8198025a21562025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f5f9b-4192-15e6-e053-2995a90a64572025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLC2b494372-de59-e462-e063-6294a90a08da2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citya225d515-430d-4e34-846c-0bfec3e741092025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City372f99c9-4ad3-4631-b8c8-2a34c47343cc2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Citye554b5b2-cf91-464a-a930-3e1087f12c8d2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City98da331c-76c2-49fe-b687-6bfba4ae2e752025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd2195efa-597d-4ba9-a9b0-8df0d8f493112025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityfba82d55-94db-4432-b532-603fe57202be2025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City9ed0fe31-e5f2-4d6d-8686-1286c66598472025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental Cityd5f42c30-343c-4e1d-950c-89bbd361fd272025-01-09WarningsExact identifier
application number: M022
Dental City Topical AnestheticBENZOCAINEICP Inc DBA Dental City7dce407f-bbe4-4a27-97ff-be33fd4474612025-01-09WarningsExact identifier
application number: M022
KAYLAANZERO WASTE REFILL FOR TOOTHPASTEKaylaan LLCcb7f28f3-a908-47a9-e053-2995a90a6cbd2025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.921bdb76-f6d3-4e0a-a0ac-277dcc4e8d282025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.a80cfd29-8314-4639-a811-afd5fdb630b02025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.69271b7a-18c0-4445-8164-cb1620fb54752025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.40bd7406-7ee6-47fe-8481-0a4c8cefce652025-01-09WarningsExact identifier
application number: M022
GPS Topical AnestheticBENZOCAINEGroup Practice Solutions, Inc.43194fe1-87a1-4ffa-ad73-a1dcec91fd632025-01-09WarningsExact identifier
application number: M022
iSmile Topical AnestheticBENZOCAINEiSmile Dental Products, Inc.b0b3ab27-704a-44b8-8473-d21ac3359ba12025-01-09WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595155benzocaine 20 % / benzalkonium chloride 0.1 % Oral GelPSNbaf0cf27-052e-4367-9a6e-75038b97a0514
1595155benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral GelSCDbaf0cf27-052e-4367-9a6e-75038b97a0514
1595155benzalkonium chloride 0.1 % / benzocaine 20 % Oral GelSYbaf0cf27-052e-4367-9a6e-75038b97a0514
1595155benzocaine 20 % / benzalkonium chloride 0.1 % Oral GelPSN18520f9b-4d35-1e9c-e063-6294a90aaa393
1595155benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral GelSCD18520f9b-4d35-1e9c-e063-6294a90aaa393
1595155benzalkonium chloride 0.1 % / benzocaine 20 % Oral GelSY18520f9b-4d35-1e9c-e063-6294a90aaa393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-060-01520000060011 TUBE in 1 CARTON (52000-060-01) > 14 g in 1 TUBE1 tube2020-12-090000-00-00NoNoCurrent
52000-060-02520000060021 TUBE in 1 CARTON (52000-060-02) / 14 g in 1 TUBE1 tube2024-05-01NoNoCurrent