FDA.reportPublic FDA data

Lidocaine 4% Patch

Product NDC
85477-302
11-digit product format
854770302
Labeler code
85477
Product ID
85477-302_38934e77-81a5-de6e-e063-6294a90a1216
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
PATCH
Route
TOPICAL
Labeler
Oncora Pharma, LLC
Application
505G(a)(3)
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-06-11
Substance
LIDOCAINE
Active strength
40 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 4% Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737778Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3763b75d-0919-cfe9-e063-6394a90a9c6fAvailable 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
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
85477-302-10Lidocaine 4% Patch1 g in 1 POUCHPATCH12
85477-302-10Lidocaine 4% Patch10 in 1 BOXPATCH102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-302-10EA - Each85477-3022cd184c6-2ac1-47cc-be27-75d4594683d012025-07-08

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 4% PatchLIDOCAINE 4%Oncora Pharma, LLC3763b75d-0919-cfe9-e063-6394a90a9c6f2025-06-27WarningsExact identifier
ndc (product): 85477-302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN3763b75d-0919-cfe9-e063-6394a90a9c6f2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD3763b75d-0919-cfe9-e063-6394a90a9c6f2
1737778lidocaine 4 % Medicated PatchSY3763b75d-0919-cfe9-e063-6394a90a9c6f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-302-108547703021010 POUCH in 1 BOX (85477-302-10) / 1 g in 1 POUCH10 pouch2025-06-11NoNoCurrent