FDA.reportPublic FDA data

Thera Plus Pain Relief Cleansing

Product NDC
80684-150
11-digit product format
806840150
Labeler code
80684
Product ID
80684-150_2f86d0c4-2bca-74f7-e063-6394a90a8f0b
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-03
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 40 mg/mL; mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Thera Plus Pain Relief Cleansing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL
LIDOCAINE HYDROCHLORIDE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui2047877

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-150-00Thera Plus Pain Relief Cleansing148 mL in 1 BOTTLELIQUID1482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-150THERA PLUS PAIN RELIEF CLEANSING (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) LIQUID [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20250306_513a620e-f69a-488d-8abc-36e2efccdc13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN513a620e-f69a-488d-8abc-36e2efccdc132
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD513a620e-f69a-488d-8abc-36e2efccdc132
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY513a620e-f69a-488d-8abc-36e2efccdc132

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-150-0080684015000148 mL in 1 BOTTLE (80684-150-00) 148 ml2025-03-03NoNoHistorical