FDA.reportPublic FDA data

TIDL PAIN RELIEF HEAT THERAPY ROLL-ON

Product NDC
84214-002
11-digit product format
842140002
Labeler code
84214
Product ID
84214-002_1d0b7b8f-9e5e-00f7-e063-6394a90af87c
Type
HUMAN OTC DRUG
Nonproprietary name
PAIN RELIEF HEAT THERAPY ROLL-ON
Dosage form
GEL
Route
TOPICAL
Labeler
Shenzhen Sam Technology Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-12
Substance
LIDOCAINE; MENTHOL
Active strength
4; 1 g/100g; g/100g
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
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g
MENTHOL1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
Rxcui1804176

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
84214-002-01TIDL PAIN RELIEF HEAT THERAPY ROLL-ON85 g in 1 BOTTLEGEL851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84214-002TIDL PAIN RELIEF HEAT THERAPY ROLL-ON (PAIN RELIEF HEAT THERAPY ROLL-ON) GEL [SHENZHEN SAM TECHNOLOGY CO., LTD.]1Current NDC, 1 package rows20240716_1d0b7b8f-9e5d-00f7-e063-6394a90af87c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1804176lidocaine 4 % / menthol 1 % Topical GelPSN1d0b7b8f-9e5d-00f7-e063-6394a90af87c1
1804176lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD1d0b7b8f-9e5d-00f7-e063-6394a90af87c1
1804176lidocaine 4 % / menthol 1 % Topical GelSY1d0b7b8f-9e5d-00f7-e063-6394a90af87c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84214-002-018421400020185 g in 1 BOTTLE (84214-002-01) 85 g2024-07-12NoNoHistorical