Comfortox Lidocaine

Product NDC
54723-998
11-digit product format
547230998
Labeler code
54723
Product ID
54723-998_b32edd96-da1d-4129-a3b8-b1ab3c718105
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Sambria Pharmaceuticals
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-09-14
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 mg/1000mg
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
54723-998-012025-01-30C16284748780-12cef2736-71f7-d83d-e063-dadaa90ab31fComfortox L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54723-998-01Comfortox Lidocaine2000 mg in 1 PACKETCREAM20006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54723-998COMFORTOX LIDOCAINE (LIDOCAINE HYDROCHLORIDE) CREAM [SAMBRIA PHARMACEUTICALS]6Legacy NDC, 1 package rows20231202_2819bbf0-df2e-4b20-b0ee-518c183bf69b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSN2819bbf0-df2e-4b20-b0ee-518c183bf69b6
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD2819bbf0-df2e-4b20-b0ee-518c183bf69b6
1010895lidocaine hydrochloride 4 % Topical CreamSY2819bbf0-df2e-4b20-b0ee-518c183bf69b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54723-998-01547230998012000 mg in 1 PACKET (54723-998-01) 2000 mg2016-09-140000-00-00NoNoCurrent