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 140 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
application number: M017
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
application number: M017
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
application number: M017
DermaWound Wound Care Venous StasisBENZOCAINE HYDROCHLORIDEProgressive Doctors, LLC6221ba86-8b7f-48c8-8284-6950f9fc36b12023-12-15WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Humco Holding Group, Inc.a8be9e46-1616-40a9-e053-2a95a90ac3bc2023-12-15WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
application number: M017
Freds Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLDiscount Drug Mart8697b932-da5a-717e-e053-2a91aa0afcae2023-12-12WarningsExact identifier
application number: M017
CVS Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLCVS86972218-31fe-6942-e053-2991aa0a88502023-12-12WarningsExact identifier
application number: M017
Best Choice Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLvalue merchandisers869631f8-aa1e-8ea4-e053-2a91aa0a5c572023-12-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Weeks & Leo Co., Inc.0c5325e3-4796-856c-e063-6394a90a1f902023-12-12WarningsExact identifier
application number: M017
Westlake Anti-itchHYDROCORTISONEWestlake Pharma LLC0c53c982-3f23-a2d5-e063-6394a90acd552023-12-12WarningsExact identifier
application number: M017
Rite Aid Anti-itchHYDROCORTISONERite Aid0c540422-1579-9217-e063-6294a90ad06a2023-12-12WarningsExact identifier
application number: M017
Anti-itch Paraben FreeHYDROCORTISONEWeeks & Leo Co., Inc.0c5419c5-0929-7ca6-e063-6294a90ac0a72023-12-12WarningsExact identifier
application number: M017
Rite Aid HydrocortisoneHYDROCORTISONE 1%Rite Aid0c580f96-7fe9-19df-e063-6394a90a5a222023-12-12WarningsExact identifier
application number: M017
Anti itchHYDROCORTISONEWeeks & Leo Co., Inc.0c58b750-d3a6-5ed1-e063-6294a90a43212023-12-12WarningsExact identifier
application number: M017
Greencaine BlastLIDOCAINEALMA Laboratories, Inc.031e0065-4c8a-43d8-bc69-3efa3c6c0ae32023-12-12WarningsExact identifier
application number: M017
Ageless Pain ReliefMETHYL SALICYLATE, MENTHOLIsagenix International, LLC3c7e493b-923d-44b1-9076-46c7894308d42023-12-12Warnings, Adverse reactionsExact identifier
application number: M017
CVS Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATECVS857af609-9dd7-a07a-e053-2991aa0ab6ba2023-12-11WarningsExact identifier
application number: M017
Rite Aid Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATERite Aid0c4170dd-e1fa-d549-e063-6394a90a5c232023-12-11WarningsExact identifier
application number: M017
Westlake Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEWestlake HB Pharma LLC0c416ba6-b01f-0609-e063-6294a90ae2a12023-12-11WarningsExact 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