TheraCare Maximum Strength Oral Pain Relief

Product NDC
71101-201
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71101-201-012025-07-29C16284748780-13b156c62-3423-fb37-e063-e6dba90a4e07TheraCare Maximum Strength Oral Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-201-01TheraCare Maximum Strength Oral Pain ReliefSevere9.35 g in 1 TUBEGEL9.353
71101-201-01TheraCare Maximum Strength Oral Pain ReliefSevere1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-201THERACARE MAXIMUM STRENGTH ORAL PAIN RELIEF SEVERE (BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%) GEL [VERIDIAN HEALTHCARE]3Legacy NDC, 2 package rows20241220_d8270f1c-b44e-ae00-e053-2a95a90aa409.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71101-201-01711010201011 TUBE in 1 CARTON (71101-201-01) > 9.35 g in 1 TUBE1 tube2022-02-010000-00-00NoNoCurrent