LIDOCAINE

Product NDC
58980-823
11-digit product format
589800823
Labeler code
58980
Product ID
58980-823_4b196450-e9de-4c85-8652-42d926d951d5
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
STRATUS PHARMACEUTICALS INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-12
Substance
LIDOCAINE
Active strength
50 mg/g
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
LIDOCAINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1534792

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
58980-823-05LIDOCAINE1 in 1 BOXCREAM15
58980-823-05LIDOCAINE14.17 g in 1 TUBECREAM14.175
58980-823-30LIDOCAINE1 in 1 BOXCREAM15
58980-823-30LIDOCAINE28.35 g in 1 TUBECREAM28.355

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-823-05GM - Gram58980-8230c01581b-9a24-4614-9a01-3fee0a2db7f812024-01-04
58980-823-30GM - Gram58980-823b35abb58-6521-430c-a784-355c1c658e9212020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-823LIDOCAINE CREAM [STRATUS PHARMACEUTICALS INC]5Current NDC, Legacy NDC, 4 package rows20241103_87a4f559-a4f6-4b9f-98de-b55b073a11c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1534792lidocaine 5 % Topical CreamPSN87a4f559-a4f6-4b9f-98de-b55b073a11c65
1534792lidocaine 50 MG/ML Topical CreamSCD87a4f559-a4f6-4b9f-98de-b55b073a11c65
1534792lidocaine 5 % Topical CreamSY87a4f559-a4f6-4b9f-98de-b55b073a11c65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58980-823-05589800823051 TUBE in 1 BOX (58980-823-05) / 14.17 g in 1 TUBE1 tube2023-12-18NoNoCurrent
58980-823-30589800823301 TUBE in 1 BOX (58980-823-30) / 28.35 g in 1 TUBE1 tube2019-08-120000-00-00NoNoCurrent