FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
69367-202
11-digit product format
693670202
Labeler code
69367
Product ID
69367-202_4aef6520-8f5d-47b8-aa1c-2b194a4fb8fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lidocaine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-08-19
Substance
LIDOCAINE HYDROCHLORIDE
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010835

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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
69367-202-01Lidocaine hydrochloride1 in 1 CARTONCREAM13
69367-202-01Lidocaine hydrochloride28.35 g in 1 TUBECREAM28.353
69367-202-85Lidocaine hydrochloride1 in 1 CARTONCREAM13
69367-202-85Lidocaine hydrochloride85 g in 1 TUBECREAM853

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-202-01GM - Gram69367-2021fd7f34c-bc7f-4470-84dc-e95ae3a92d4112020-01-03
69367-202-85GM - Gram69367-2023997ee08-0179-492f-bcd5-acf9d680ea8312020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-202LIDOCAINE HYDROCHLORIDE CREAM [WESTMINSTER PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 4 package rows20201202_6702589d-6a15-40fe-877a-a9a1a4ad0f7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010835lidocaine HCl 3 % Topical CreamPSN6702589d-6a15-40fe-877a-a9a1a4ad0f7a3
1010835lidocaine hydrochloride 30 MG/ML Topical CreamSCD6702589d-6a15-40fe-877a-a9a1a4ad0f7a3
1010835lidocaine hydrochloride 3 % Topical CreamSY6702589d-6a15-40fe-877a-a9a1a4ad0f7a3
1010835lidocaine HCl 3 % Topical CreamPSN5b4b36dd-da60-47de-a2c1-517a52ab35491
1010835lidocaine hydrochloride 30 MG/ML Topical CreamSCD5b4b36dd-da60-47de-a2c1-517a52ab35491
1010835lidocaine hydrochloride 3 % Topical CreamSY5b4b36dd-da60-47de-a2c1-517a52ab35491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-202-01693670202011 TUBE in 1 CARTON (69367-202-01) / 28.35 g in 1 TUBE1 tube2019-08-190000-00-00NoNoCurrent
69367-202-85693670202851 TUBE in 1 CARTON (69367-202-85) / 85 g in 1 TUBE1 tube2019-08-190000-00-00NoNoCurrent