Home NDC 52000-060 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 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52000-060-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52000-060-01 f5e01cc5f278…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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE .2 g/g BENZALKONIUM CHLORIDE .01 g/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup F5UM2KM3W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1595155 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52000-060-01 Oral Pain Relief 14 g in 1 TUBE GEL 14 4 52000-060-01 Oral Pain Relief 1 in 1 CARTON GEL 1 4 52000-060-02 Oral Pain Relief 14 g in 1 TUBE GEL 14 3 52000-060-02 Oral Pain Relief 1 in 1 CARTON GEL 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52000-060 ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241212_baf0cf27-052e-4367-9a6e-75038b97a051.zip 52000-060 ORAL PAIN RELIEF (BENZOCAINE AND BENZALKONIUM CHLORIDE) GEL [UNIVERSAL DISTRIBUTION CENTER LLC] 2 Current NDC, Legacy NDC, 2 package rows 20241218_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 14 of 40 · 782 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52000-060-01 52000006001 1 TUBE in 1 CARTON (52000-060-01) > 14 g in 1 TUBE 1 tube 2020-12-09 0000-00-00 No No Current 52000-060-02 52000006002 1 TUBE in 1 CARTON (52000-060-02) / 14 g in 1 TUBE 1 tube 2024-05-01 No No Current