FDA.reportPublic FDA data

TheraCare Pain Relief 4% Lidocaine

Product NDC
71101-059
11-digit product format
711010059
Labeler code
71101
Product ID
71101-059_30118985-4627-4636-e063-6294a90a8835
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
PERCUTANEOUS; TOPICAL; TRANSDERMAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-01
Substance
LIDOCAINE
Active strength
4 g/100g
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
TheraCare Pain Relief 4% Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

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
2d3fc030-5d53-2acd-e063-6294a90a11abAvailable 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
71101-059-05TheraCare Pain Relief 4% Lidocaine1 g in 1 POUCHPATCH12
71101-059-05TheraCare Pain Relief 4% Lidocaine5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-059THERACARE PAIN RELIEF 4% LIDOCAINE (LIDOCAINE) PATCH [VERIDIAN HEALTHCARE]2Current NDC, 2 package rows20250313_2d3fc030-5d53-2acd-e063-6294a90a11ab.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 26 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHORSinsin Pharmaceutical Co., Ltd.47c077c2-6e34-8e7a-e063-6294a90a21b52026-04-08WarningsExact identifier
application number: M017
Yi Tiao Gen Pain PatchPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory4828fe70-f6f8-45e4-9c9a-a9e486dc65e52026-04-07WarningsExact identifier
application number: M017
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsExact identifier
application number: M017
KinetiCream Pain Relieving Topical AnalgesicMENTHOLPhoenix Bioperformance Products LLCbb4c9e73-e62d-4b8c-a16c-b90db1a8b2a72026-04-06WarningsExact identifier
application number: M017
KinetiCream Anti-Inflammatory and Pain ReliefMENTHOLPhoenix Bioperformance Products LLC39a6d26b-b5f4-45d7-a9b5-6edbf42d75002026-04-06WarningsExact identifier
application number: M017
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN2d3fc030-5d53-2acd-e063-6294a90a11ab2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2d3fc030-5d53-2acd-e063-6294a90a11ab2
1737778lidocaine 4 % Medicated PatchSY2d3fc030-5d53-2acd-e063-6294a90a11ab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-059-05711010059055 POUCH in 1 BOX (71101-059-05) / 1 g in 1 POUCH5 pouch2025-02-01NoNoCurrent