FDA.reportPublic FDA data

Oral Pain Relief

Product NDC
52000-060
11-digit product format
520000060
Labeler code
52000
Product ID
52000-060_28d09e8b-190f-40da-ab8a-9bd2d41ae419
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
BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength
.01; .2 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oral Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, U3RSY48JW5
Rxcui1595155

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

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