FDA.reportPublic FDA data

Lidocaine Viscous

Product NDC
0054-3500
11-digit product format
000543500
Labeler code
0054
Product ID
0054-3500_182f3e6b-1622-4eef-80e5-d08ffbbbd30e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SOLUTION
Route
ORAL; TOPICAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA088802
Marketing category
ANDA
Marketing start
1985-04-26
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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 Viscous
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010739

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
0054-3500-49Lidocaine Viscous1 in 1 CARTONSOLUTION115
0054-3500-49Lidocaine Viscous100 mL in 1 BOTTLESOLUTION10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-3500-49ML - Milliliter0054-3500bf684545-db08-4cae-9097-07f5122c975312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [ROXANE LABORATORIES,INC]7
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE VISCOUS SOLUTION [DIRECT RX]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE VISCOUS SOLUTION [DIRECT RX]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311LIDOCAINE VISCOUS SOLUTION [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE VISCOUS SOLUTION [DIRECT RX]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE VISCOUS SOLUTION [DIRECT RX]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYLIDOCAINE VISCOUS SOLUTION [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0054-3500LIDOCAINE VISCOUS (LIDOCAINE HYDROCHLORIDE) SOLUTION [HIKMA PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20241219_79b42076-359d-4258-b1d8-f40e67ac5424.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN79b42076-359d-4258-b1d8-f40e67ac542415
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD79b42076-359d-4258-b1d8-f40e67ac542415
1010739lidocaine HCl 2 % Oral Topical SolutionSY79b42076-359d-4258-b1d8-f40e67ac542415
1010739lidocaine HCl 2 % Oromucosal SolutionSY79b42076-359d-4258-b1d8-f40e67ac542415
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN6f8d20d2-6a91-4a5b-bfe8-f1baada384424
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD6f8d20d2-6a91-4a5b-bfe8-f1baada384424
1010739lidocaine HCl 2 % Oral Topical SolutionSY6f8d20d2-6a91-4a5b-bfe8-f1baada384424
1010739lidocaine HCl 2 % Oromucosal SolutionSY6f8d20d2-6a91-4a5b-bfe8-f1baada384424
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN4b54a311-fe39-4ce5-b50f-4d39ef2452ec3
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN75f2d450-aa2e-4a09-b4f7-4fcbcbf8b2053
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD75f2d450-aa2e-4a09-b4f7-4fcbcbf8b2053
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD4b54a311-fe39-4ce5-b50f-4d39ef2452ec3
1010739lidocaine HCl 2 % Oral Topical SolutionSY4b54a311-fe39-4ce5-b50f-4d39ef2452ec3
1010739lidocaine HCl 2 % Oral Topical SolutionSY75f2d450-aa2e-4a09-b4f7-4fcbcbf8b2053
1010739lidocaine HCl 2 % Oromucosal SolutionSY4b54a311-fe39-4ce5-b50f-4d39ef2452ec3
1010739lidocaine HCl 2 % Oromucosal SolutionSY75f2d450-aa2e-4a09-b4f7-4fcbcbf8b2053
1010739lidocaine HCl 2 % Mucous Membrane Topical SolutionPSN0050d05a-b8e9-c544-e063-6294a90a02432
1010739lidocaine hydrochloride 20 MG/ML Mucous Membrane Topical SolutionSCD0050d05a-b8e9-c544-e063-6294a90a02432
1010739lidocaine HCl 2 % Oral Topical SolutionSY0050d05a-b8e9-c544-e063-6294a90a02432
1010739lidocaine HCl 2 % Oromucosal SolutionSY0050d05a-b8e9-c544-e063-6294a90a02432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0054-3500-49000543500491 BOTTLE in 1 CARTON (0054-3500-49) / 100 mL in 1 BOTTLE1 bottle1985-04-260000-00-00NoNoCurrent