FDA.reportPublic FDA data

TRIDERMA PAIN RELIEF

Product NDC
10738-073
11-digit product format
107380073
Labeler code
10738
Product ID
10738-073_496701e3-f506-de4f-e063-6294a90a70ff
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Genuine Virgin Aloe Corporation
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-30
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TRIDERMA PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE4 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui1595624

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10738-073-202023-02-02C16284748780-1f386c649-d617-0266-e053-dadaa90a7c1aTRIDERMA PAIN RELIEF CREAM
10738-073-412023-02-02C16284748780-1f386c649-d617-0266-e053-dadaa90a7c1aTRIDERMA PAIN RELIEF CREAM
10738-073-202023-01-30C16284748780-1f386c649-d617-0266-e053-dadaa90a7c1aTRIDERMA PAIN RELIEF CREAM
10738-073-412023-01-30C16284748780-1f386c649-d617-0266-e053-dadaa90a7c1aTRIDERMA PAIN RELIEF CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10738-073-21TRIDERMA PAIN RELIEF57 g in 1 JARCREAM575
10738-073-41TRIDERMA PAIN RELIEF113 g in 1 JARCREAM1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10738-073TRIDERMA PAIN RELIEF (LIDOCAINE HCL, MENTHOL) CREAM [GENUINE VIRGIN ALOE CORPORATION]4Current NDC, Legacy NDC, 2 package rows20250101_9172d6cd-f7d3-421e-a8b5-c1cb3325ada5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN9172d6cd-f7d3-421e-a8b5-c1cb3325ada55
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD9172d6cd-f7d3-421e-a8b5-c1cb3325ada55
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY9172d6cd-f7d3-421e-a8b5-c1cb3325ada55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10738-073-20107380073201 JAR in 1 CARTON (10738-073-20) > 57 g in 1 JAR (10738-073-21) 1 jar2019-08-300000-00-00NoNoCurrent
10738-073-211073800732157 g in 1 JAR (10738-073-21) 57 g2019-08-30NoNoCurrent
10738-073-4110738007341113 g in 1 JAR (10738-073-41) 113 g2019-08-300000-00-00NoNoCurrent