Home NDC 71101-201-01 TheraCare Maximum Strength Oral Pain Relief
Product NDC 71101-201
Requested package NDC 71101-201-01
11-digit product format 711010201
Labeler code 71101
Product ID 71101-201_eb7928eb-82fe-46c4-e053-2a95a90aa268
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine 20%, Benzalkonium Chloride 1%
Dosage form GEL
Route TOPICAL
Labeler Veridian Healthcare
Application part356
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2022-02-01
Marketing end 0000-00-00
Substance BENZALKONIUM CHLORIDE; BENZOCAINE
Active strength 10 mg/g; 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 2023-12-31
Current FDA listing Historical FDA.report record 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 71101-201 71101-201-01 I Inactivated by FDA excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 71101-201 71101-201-01 I Inactivated by FDA excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71101-201-01 TheraCare Maximum Strength Oral Pain ReliefSevere 9.35 g in 1 TUBE GEL 9.35 3 71101-201-01 TheraCare Maximum Strength Oral Pain ReliefSevere 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 71101-201 THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF SEVERE (BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%) GEL [VERIDIAN HEALTHCARE] 3 Legacy NDC, 2 package rows 20241220_d8270f1c-b44e-ae00-e053-2a95a90aa409.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71101-201-01 71101020101 1 TUBE in 1 CARTON (71101-201-01) > 9.35 g in 1 TUBE 1 tube 2022-02-01 0000-00-00 No No Current