FDA.reportPublic FDA data

Lidocaine hydrochloride

Product NDC
69367-202
Requested package NDC
69367-202-85
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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010835Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6702589d-6a15-40fe-877a-a9a1a4ad0f7aAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC6702589d-6a15-40fe-877a-a9a1a4ad0f7a2020-11-30Warnings, Adverse reactionsExact identifier
ndc (package): 69367-202-85
ndc (product): 69367-202
ndc11 (package): 69367020285

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
69367-202-85693670202851 TUBE in 1 CARTON (69367-202-85) / 85 g in 1 TUBE1 tube2019-08-190000-00-00NoNoCurrent