Lidocaine

Product NDC
83589-301
11-digit product format
835890301
Labeler code
83589
Product ID
83589-301_47b01c48-9126-2714-e063-6394a90a6d53
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Nanjing Chengong Pharmaceutical Co., Ltd.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-04
Substance
LIDOCAINE
Active strength
1.2 g/30g
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
Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE1.2 g/30g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui2678387

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83589-301-01Lidocaine30 g in 1 TUBECREAM302
83589-301-01Lidocaine1 in 1 BOXCREAM12
83589-301-02Lidocaine1 in 1 BOXCREAM12
83589-301-02Lidocaine25 g in 1 TUBECREAM252
83589-301-03Lidocaine120 g in 1 TUBECREAM1202
83589-301-03Lidocaine1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83589-301LIDOCAINE CREAM [NANJING CUCCESS PHARMACEUTICAL CO., LTD.]1Current NDC, 6 package rows20240404_fbdea732-3f0b-c5a0-e053-6394a90a10a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2678387lidocaine 4 % Rectal CreamPSNfbdea732-3f0b-c5a0-e053-6394a90a10a02
2678387lidocaine 40 MG/ML Rectal CreamSCDfbdea732-3f0b-c5a0-e053-6394a90a10a02
2678387lidocaine 4 % Rectal CreamSYfbdea732-3f0b-c5a0-e053-6394a90a10a02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83589-301-01835890301011 TUBE in 1 BOX (83589-301-01) / 30 g in 1 TUBE1 tube2024-04-04NoNoHistorical
83589-301-02835890301021 TUBE in 1 BOX (83589-301-02) / 25 g in 1 TUBE1 tube2024-04-04NoNoHistorical
83589-301-03835890301031 TUBE in 1 BOX (83589-301-03) / 120 g in 1 TUBE1 tube2024-04-04NoNoHistorical