FDA.reportPublic FDA data

Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon

Product NDC
69693-002
11-digit product format
696930002
Labeler code
69693
Product ID
69693-002_4482d34d-eacb-5522-e063-6394a90a6afb
Type
HUMAN OTC DRUG
Nonproprietary name
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon
Dosage form
LIQUID
Route
TOPICAL
Labeler
Clarion Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-15
Substance
BENZYL ALCOHOL; LIDOCAINE HYDROCHLORIDE
Active strength
10; 4 g/100mL; g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Pediculicide [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-002-25Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Rollon1 mL in 1 BOTTLELIQUID11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionPSN4482d34d-eaca-5522-e063-6394a90a6afb1
1943537benzyl alcohol 0.1 ML/ML / lidocaine hydrochloride 40 MG/ML Topical SolutionSCD4482d34d-eaca-5522-e063-6394a90a6afb1
1943537benzyl alcohol 10 % / lidocaine HCl 4 % Topical SolutionSY4482d34d-eaca-5522-e063-6394a90a6afb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69693-002-25696930002251 mL in 1 BOTTLE (69693-002-25) 1 ml2025-11-15NoNoHistorical