FDA.reportPublic FDA data

LIDOGUARD

Product NDC
85231-100
11-digit product format
852310100
Labeler code
85231
Product ID
85231-100_4dd75a34-1b69-c67d-e063-6394a90a1007
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
PATCH
Route
TOPICAL
Labeler
ViolaCare, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-01
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
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
LIDOGUARD
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1737778Internal RxNorm lookup
2717286Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d8b021b6-cf71-4f7e-9d27-92d0982bd34fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-100-15LIDOGUARD1 in 1 POUCHPATCH13
85231-100-15LIDOGUARD15 in 1 BOXPATCH153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-100-15EA - Each85231-100f811c00d-2a9b-4627-a235-4b1b022a221712025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85231-100LIDOGUARD (LIDOCAINE 4%) PATCH [VIOLACARE, INC.]1Current NDC, 2 package rows20250515_d8b021b6-cf71-4f7e-9d27-92d0982bd34f.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 137 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-OnMENTHOLTARGET CORPORATION0f95fc55-8665-9e89-e063-6394a90a78912024-01-22WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain Relief Plus MentholLIDOCAINE, MENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.77978069-a1b4-473e-83c9-8320e00eea892024-01-19WarningsExact identifier
application number: M017
ZIMS MAX FREEZE LEG CRAMPSCAMPHOR, MENTHOLKOBAYASHI Healthcare International, Inc.ba26635d-95d3-4d88-93cc-1fd4fd29fd792024-01-18WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
application number: M017
Medi-First Hydrocortisone 1%HYDROCORTISONE ACETATEUnifirst First Aid Corporationbd216f5d-f304-7d8d-e053-2a95a90aa9ce2024-01-17WarningsExact identifier
application number: M017
Green Guard Hydrocortisone 1%HYDROCORTISONEUnifirst First Aid Corporationbd348e2a-57b1-3f17-e053-2a95a90a8bdc2024-01-17WarningsExact identifier
application number: M017
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain ReliefLIDOCAINENatural Essentials, Inc.52e82e70-53b7-4ecb-be39-fe10c94cc4442024-01-17WarningsExact identifier
application number: M017
CVS Health XL Lidocaine Pain ReliefLIDOCAINENATURAL ESSENTIALS, INC.ec16da91-8244-402b-b8d8-84896094ac2c2024-01-17WarningsExact identifier
application number: M017
Anti-itchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATETarget Corporationf444b0a6-2ed3-4236-8206-3421502906752024-01-17WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Anti-itchHYDROCORTISONE 1%Target Corporation4ff39cb8-3a20-4fe7-9829-1e882a4846682024-01-17WarningsExact identifier
application number: M017
BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.eca272cb-ac8f-982b-e053-2995a90aa8b22024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNd8b021b6-cf71-4f7e-9d27-92d0982bd34f3
2717286LidoGuard 4 % Medicated PatchPSNd8b021b6-cf71-4f7e-9d27-92d0982bd34f3
2717286lidocaine 0.04 MG/MG Medicated Patch [Lidoguard Pain Relief]SBDd8b021b6-cf71-4f7e-9d27-92d0982bd34f3
1737778lidocaine 0.04 MG/MG Medicated PatchSCDd8b021b6-cf71-4f7e-9d27-92d0982bd34f3
1737778lidocaine 4 % Medicated PatchSYd8b021b6-cf71-4f7e-9d27-92d0982bd34f3
2717286Lidoguard Pain Relief 0.04 MG/MG Medicated PatchSYd8b021b6-cf71-4f7e-9d27-92d0982bd34f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85231-100-158523101001515 POUCH in 1 BOX (85231-100-15) / 1 PATCH in 1 POUCH / 4 g in 1 PATCH15 pouch2025-05-01NoNoCurrent