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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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