FDA.reportPublic FDA data

LidoPro Pain Relief

Product NDC
68788-8833
11-digit product format
687888833
Labeler code
68788
Product ID
68788-8833_c259ef92-5d07-4590-adf1-3a106333eee0
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin and Lidocaine
Dosage form
OINTMENT
Route
TRANSDERMAL
Labeler
Preferred Pharmaceuticals Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-21
Substance
MENTHOL, (+)-; LIDOCAINE HYDROCHLORIDE; METHYL SALICYLATE; CAPSAICIN
Active strength
10; 4; 27.5; .0325 mg/100mg; mg/100mg; mg/100mg; mg/100mg
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

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 Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, (+)-10 mg/100mg
LIDOCAINE HYDROCHLORIDE4 mg/100mg
METHYL SALICYLATE27.5 mg/100mg
CAPSAICIN.0325 mg/100mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C6B1OE8P3WInternal UNII lookup
V13007Z41AInternal UNII lookup
LAV5U5022YInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1601095Internal RxNorm lookup
1601097Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c259ef92-5d07-4590-adf1-3a106333eee0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8833-9LidoPro Pain Relief9900 mg in 1 TUBE, WITH APPLICATOROINTMENT99001
68788-8833-9LidoPro Pain Relief1 in 1 BOXOINTMENT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8833-9GM - Gram68788-8833871dadf0-6e0b-4e84-97c6-e63bcfdd2b9e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8833LIDOPRO PAIN RELIEF (CAPSAICIN AND LIDOCAINE) OINTMENT [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250224_c259ef92-5d07-4590-adf1-3a106333eee0.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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a16c6aa-3ab0-3e46-e063-6294a90a6d8f2026-08-27WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
application number: M017
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
application number: M017
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsExact identifier
application number: M017
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsExact identifier
application number: M017
TERAPIA DE DIA Y NOCHEPAIN RELIEVING PATCHDW SUPPORT LLC59f44135-865b-9d7d-e063-6294a90a9dd92026-08-26WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentPSNc259ef92-5d07-4590-adf1-3a106333eee01
1601097LidoPro 0.0325 % / 4 % / 10 % / 27.5 % Topical OintmentPSNc259ef92-5d07-4590-adf1-3a106333eee01
1601097capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical Ointment [LidoPro]SBDc259ef92-5d07-4590-adf1-3a106333eee01
1601095capsaicin 0.000325 MG/MG / lidocaine hydrochloride 0.04 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.275 MG/MG Topical OintmentSCDc259ef92-5d07-4590-adf1-3a106333eee01
1601095capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % Topical OintmentSYc259ef92-5d07-4590-adf1-3a106333eee01
1601097LidoPro (capsaicin 0.0325 % / lidocaine HCl 4 % / menthol 10 % / methyl salicylate 27.5 % ) Topical OintmentSYc259ef92-5d07-4590-adf1-3a106333eee01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8833-9687888833091 TUBE, WITH APPLICATOR in 1 BOX (68788-8833-9) / 9900 mg in 1 TUBE, WITH APPLICATOR2025-02-21NoNoCurrent