FDA.reportPublic FDA data

LidoPro

Product NDC
83881-403
11-digit product format
838810403
Labeler code
83881
Product ID
83881-403_57ad33f7-c82c-4553-e063-6294a90a55aa
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine and menthol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Clinic Pharma
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-11
Substance
LIDOCAINE; MENTHOL
Active strength
.04; .01 g/g; g/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
LidoPro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE.04 g/g
MENTHOL.01 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249758Internal RxNorm lookup
2675625Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cdfd6b39-b430-4e95-a0f7-682cf3d78b52Available 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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
83881-403-01LidoPro10 g in 1 PATCHPATCH101
83881-403-01LidoPro1 in 1 POUCHPATCH11
83881-403-15LidoPro15 in 1 CARTONPATCH151
83881-403-15LidoPro1 in 1 POUCHPATCH11
83881-403-30LidoPro1 in 1 POUCHPATCH11
83881-403-30LidoPro30 in 1 CARTONPATCH301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83881-403-15EA - Each83881-4034897e453-a513-428c-9f59-375dae5f81c312026-05-22
83881-403-30EA - Each83881-4036340e229-b72a-4e02-8baf-b3d7fb18b6cc12026-05-22

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 18 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Biofreeze Overnight Roll-onMENTHOLReckitt Benckiser LLCf67d7b7a-8922-73f6-e053-2995a90a2e802026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight ReliefMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC07be6e88-1850-4d6a-946d-f03830b8c4a22026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-On and Overnight Roll-OnMENTHOLReckitt Benckiser LLC4d3dcb8f-2075-6bbc-e063-6394a90a49922026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6bef9ccb-7a5a-4c67-b1bc-a92b167312da2026-05-15WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLReckitt Benckiser LLCebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb2026-05-15WarningsExact identifier
application number: M017
Biofreeze Precision Relief PenMENTHOLReckitt Benckiser LLCb4cc1db5-a33f-17bc-e053-2995a90ab7eb2026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCdb982baf-31ea-4f09-90e3-cd5facb5dfe52026-05-15WarningsExact identifier
application number: M017
Biofreeze Professional Roll-OnMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLCf62f8ec3-593d-480a-85a0-01fcd7f1790c2026-05-15WarningsExact identifier
application number: M017
PERFORM COOL AND SOOTHING PAIN RELIEVING ROLL-ONMENTHOLReckitt Benckiser LLC8af185ad-719e-4684-89c0-9c17c12774992026-05-15WarningsExact identifier
application number: M017
PERFORM COOL and SOOTHING PAIN RELIEVINGMENTHOLReckitt Benckiser LLCef158f63-2d75-47a3-b94a-2d821d5118632026-05-15WarningsExact identifier
application number: M017
KY Duration for HimLIDOCAINEReckitt Benckiser LLC83cc86bd-3303-4956-a198-fae85b6e34e12026-05-15WarningsExact identifier
application number: M017
4% LIDOCAINE PATCHES4% LIDOCAINEShenzhen Huayuan Hengsheng Technology Co., Ltd.4f53cfd3-a7c4-e308-e063-6294a90ad6982026-05-14WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLCardinal Health, 110 dba LEADER77066d01-75b0-4a8d-88d3-c639626d33262026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnLIDOCAINETrifecta Pharmaceuticals USA51cb6797-55ec-7a7a-e063-6294a90a90ee2026-05-14WarningsExact identifier
application number: M017
Pain Relief Gel-Roll OnMENTHOLTrifecta Pharmaceuticals USA51b403dc-fc9b-0cad-e063-6394a90af0812026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC5edddb99-6596-4a3b-b361-1cc04d032c312026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC684faf63-5e44-4471-8384-e8fa7c0d842a2026-05-13WarningsExact identifier
application number: M017
BiofreezeMENTHOLReckitt Benckiser LLC4c798b06-6ee5-41d1-8a14-f6889512ade32026-05-13WarningsExact identifier
application number: M017
BIOFREEZEMENTHOLReckitt Benckiser LLC83d5c2f2-2413-4d28-83b2-0808d0917b4d2026-05-13WarningsExact identifier
application number: M017
Scalpicin Anti-Itch Maximum StrengthHYDROCORTISONEReckitt Benckiser LLC7b1a29fa-b266-43e6-a87b-aa3c96ab40412026-05-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN4faa515f-6040-d948-e063-6294a90a187f1
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNcdfd6b39-b430-4e95-a0f7-682cf3d78b521
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSN4faa515f-6040-d948-e063-6294a90a187f1
2675625LidoPro Pain Relieving Patch 4 % / 1 % Medicated PatchPSNcdfd6b39-b430-4e95-a0f7-682cf3d78b521
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBD4faa515f-6040-d948-e063-6294a90a187f1
2675625lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [LidoPro Pain Relieving Patch]SBDcdfd6b39-b430-4e95-a0f7-682cf3d78b521
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD4faa515f-6040-d948-e063-6294a90a187f1
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDcdfd6b39-b430-4e95-a0f7-682cf3d78b521
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY4faa515f-6040-d948-e063-6294a90a187f1
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYcdfd6b39-b430-4e95-a0f7-682cf3d78b521
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSY4faa515f-6040-d948-e063-6294a90a187f1
2675625LidoPro Pain Relieving Patch (lidocaine 4 % / menthol 1 % ) Medicated PatchSYcdfd6b39-b430-4e95-a0f7-682cf3d78b521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83881-403-01838810403011 PATCH in 1 POUCH (83881-403-01) / 10 g in 1 PATCH1 patch2026-03-11NoNoCurrent
83881-403-108388104031010 POUCH in 1 CARTON (83881-403-10) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH10 pouch2026-07-28NoNoCurrent
83881-403-158388104031515 POUCH in 1 CARTON (83881-403-15) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH15 pouch2026-03-11NoNoCurrent
83881-403-308388104033030 POUCH in 1 CARTON (83881-403-30) / 1 PATCH in 1 POUCH / 10 g in 1 PATCH30 pouch2026-03-11NoNoCurrent