FDA.reportPublic FDA data

Lidocaine

Product NDC
58980-826
11-digit product format
589800826
Labeler code
58980
Product ID
58980-826_029f4902-bc3a-4fd9-8b5e-388d8ae9cf61
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
2024-02-15
Substance
LIDOCAINE
Active strength
30 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
LIDOCAINE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui2049533

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
58980-826-30Lidocaine1 in 1 BOXCREAM12
58980-826-30Lidocaine28.35 g in 1 TUBECREAM28.352
58980-826-85Lidocaine85 g in 1 TUBECREAM852
58980-826-85Lidocaine1 in 1 BOXCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-826-30GM - Gram58980-826a31db386-c391-4bf8-9218-e7465825234712024-02-14
58980-826-85GM - Gram58980-826d8356ac3-09de-4e2e-8e45-51551fb7ca5412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-826LIDOCAINE CREAM [STRATUS PHARMACEUTICALS INC]1Current NDC, 4 package rows20240215_5eb6574c-2066-4390-befc-8e5d2dd6ede2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2049533lidocaine 3 % Topical CreamPSN5eb6574c-2066-4390-befc-8e5d2dd6ede22
2049533lidocaine 30 MG/ML Topical CreamSCD5eb6574c-2066-4390-befc-8e5d2dd6ede22
2049533lidocaine 3 % Topical CreamSY5eb6574c-2066-4390-befc-8e5d2dd6ede22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58980-826-30589800826301 TUBE in 1 BOX (58980-826-30) / 28.35 g in 1 TUBE1 tube2024-02-15NoNoCurrent
58980-826-85589800826851 TUBE in 1 BOX (58980-826-85) / 85 g in 1 TUBE1 tube2025-07-01NoNoCurrent