FDA.reportPublic FDA data

Antibacterial Lidocaine Wound Gel

Product NDC
59898-950
11-digit product format
598980950
Labeler code
59898
Product ID
59898-950_474af77e-7568-d8f0-e063-6294a90a7fc9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Water-Jel Technologies, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-28
Substance
LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Active strength
2; .13 g/100mL; g/100mL
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
Antibacterial Lidocaine Wound Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100mL
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1431682Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ef1a6100-7f78-1fdb-e053-2a95a90abf20Available 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
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
59898-950-01Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
59898-950-01Antibacterial Lidocaine Wound Gel14 mL in 1 TUBEGEL143
59898-950-02Antibacterial Lidocaine Wound Gel1 in 1 CARTONGEL13
59898-950-02Antibacterial Lidocaine Wound Gel28 mL in 1 TUBEGEL283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-950ANTIBACTERIAL LIDOCAINE WOUND GEL (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES, LLC]2Current NDC, Legacy NDC, 4 package rows20240129_ef1a6100-7f78-1fdb-e053-2a95a90abf20.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 45 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DZUL - LIDO CREMELIDOCAINE HCL, MENTHOLCaball Sales, Inc.063387e4-a1b1-a467-e063-6294a90a6cbd2026-01-08WarningsExact identifier
application number: M017
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
application number: M017
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
application number: M017
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLUniversal Distribution Center LLC66892993-a755-4584-b2a8-2e8d7ac705932026-01-08WarningsExact identifier
application number: M017
Private Label Antifungal Barrier Cream2% MICONAZOLE NITRATE CREAMSwiss-American CDMO, LLCe74bddea-c1ac-4e4e-84bd-5a9defb85b2d2026-01-08WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLCe1911279-85f7-4053-b6da-8f4e991347a22026-01-08WarningsExact identifier
application number: M017
POMG PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDE, MENTHOLPOMG LLC1fa980fb-fc0e-fdd0-e063-6394a90adc132026-01-07WarningsExact identifier
application number: M017
Artridon GlucosamineMENTHOL, METHYL SALICYLATEPharmadel LLC73572156-4cce-0669-e053-2991aa0aaecc2026-01-07WarningsExact identifier
application number: M017
HealthWise Cooling Pain ReliefMENTHOLVeridian Healthcare6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd2026-01-07WarningsExact identifier
application number: M017
Hydrocortisone 1% Anti-Itch CreamHYDROCORTISONEDLC Laboratories, Inc.16eeec2c-065d-4da0-e063-6294a90a38732026-01-07WarningsExact identifier
application number: M017
Maximum Strength HydrocortisoneHYDROCORTISONEDLC Laboratories, Inccaf50f12-f35c-4e9e-8ef7-3b0c84e225ee2026-01-07WarningsExact identifier
application number: M017
EARTHS CARE MUSCLE AND JOINT RUBCAMPHORDLC Laboratories, Inc.71e33e06-4dc3-4ead-a122-ff89d93a64de2026-01-07WarningsExact identifier
application number: M017
Amour CBDPAIN RELIEF CREAMSVD Premium Products95b45e79-b1e7-17b2-e053-2995a90a88362026-01-07WarningsExact identifier
application number: M017
Tiger Balm Active MuscleMETHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.845a4ead-f9c0-4009-bcae-b17cd388439b2026-01-07WarningsExact identifier
application number: M017
3X Medicated Toothache and Gum GelBENZOCAINERite Aid996f7989-17ce-5b28-e053-2995a90af8b82026-01-06WarningsExact identifier
application number: M017
QNTAMAX Muscle and Joint Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLQntamax LLC6622b94c-824e-4e84-a8d8-b60bb0b866e22026-01-06WarningsExact identifier
application number: M017
Winco Muscle and Joint Pain Relief Gel 2ozWINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEFWINCO FOODS, LLC47bedf4e-4036-cf43-e063-6394a90a91d62026-01-06WarningsExact identifier
application number: M017
Pain Relief Hot PatchMENTHOL AND CAPSAICINUniversal Distribution Center LLC110bcb16-ef0b-4bc8-8877-173a0494e1ad2026-01-06WarningsExact identifier
application number: M017
WOFANLI Quit Smoking Nicotine PatchesNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4582b4e9-0c24-069d-e063-6394a90a6f4b2026-01-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSN960bfe55-87f6-3e51-e053-2995a90a867d5
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCD960bfe55-87f6-3e51-e053-2995a90a867d5
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSY960bfe55-87f6-3e51-e053-2995a90a867d5
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSNcb9505b7-222d-3a24-e053-2a95a90a0b643
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSNef1a6100-7f78-1fdb-e053-2a95a90abf203
1431682benzalkonium chloride 0.13 % / lidocaine HCl 2 % Topical GelPSNeff77965-dc7f-49af-e053-2995a90a1a973
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCDcb9505b7-222d-3a24-e053-2a95a90a0b643
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCDef1a6100-7f78-1fdb-e053-2a95a90abf203
1431682benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.02 MG/MG Topical GelSCDeff77965-dc7f-49af-e053-2995a90a1a973
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSYcb9505b7-222d-3a24-e053-2a95a90a0b643
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSYef1a6100-7f78-1fdb-e053-2a95a90abf203
1431682benzalkonium chloride 0.13 % / lidocaine hydrochloride 2 % Topical GelSYeff77965-dc7f-49af-e053-2995a90a1a973

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-950-01598980950011 TUBE in 1 CARTON (59898-950-01) / 14 mL in 1 TUBE1 tube2019-10-280000-00-00NoNoCurrent
59898-950-02598980950021 TUBE in 1 CARTON (59898-950-02) / 28 mL in 1 TUBE1 tube2019-10-280000-00-00NoNoCurrent