FDA.reportPublic FDA data

ZYLOTROL PAIN RELIEVING

Product NDC
81902-230
11-digit product format
819020230
Labeler code
81902
Product ID
81902-230_229a56ae-aced-33d9-e063-6394a90a477d
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl, Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Whitestone Products LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-29
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYLOTROL PAIN RELIEVING
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81902-230-01ZYLOTROL PAIN RELIEVING102 g in 1 TUBECREAM1023
81902-230-02ZYLOTROL PAIN RELIEVING102 g in 1 JARCREAM1023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-230-01GM - Gram81902-230a0ffe8f5-dc3b-4a71-bc6d-378595bd6ff712023-04-07
81902-230-02GM - Gram81902-2303c17f3a7-2555-4d51-b8c2-64538b2f965912024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81902-230ZYLOTROL PAIN RELIEVING (LIDOCAINE HCL, MENTHOL) CREAM [WHITESTONE PRODUCTS LLC]3Current NDC, Legacy NDC, 2 package rows20240924_2301fed7-0fa9-450d-8b1b-006f53235be0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN1553351c-aee8-4c40-9548-35cce246bda93
1595624lidocaine HCl 4 % / menthol 1 % Topical CreamPSN2301fed7-0fa9-450d-8b1b-006f53235be03
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD1553351c-aee8-4c40-9548-35cce246bda93
1595624lidocaine hydrochloride 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2301fed7-0fa9-450d-8b1b-006f53235be03
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY1553351c-aee8-4c40-9548-35cce246bda93
1595624lidocaine hydrochloride 4 % / menthol 1 % Topical CreamSY2301fed7-0fa9-450d-8b1b-006f53235be03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81902-230-0181902023001102 g in 1 TUBE (81902-230-01) 102 g2022-12-290000-00-00NoNoCurrent
81902-230-0281902023002102 g in 1 JAR (81902-230-02) 102 g2024-09-21NoNoHistorical