FDA.reportPublic FDA data

XeroBurn Burn Gel

Product NDC
67777-129
11-digit product format
677770129
Labeler code
67777
Product ID
67777-129_303feeb7-93b4-5920-e063-6394a90a0caf
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-09-07
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
2 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
XeroBurn Burn Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58985046-ca9c-12be-e053-2991aa0abe72Available 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
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
67777-129-00XeroBurn Burn Gel3.5 g in 1 PACKETGEL3.57
67777-129-00XeroBurn Burn Gel25 in 1 BOXGEL257
67777-129-01XeroBurn Burn Gel3.5 g in 1 PACKETGEL3.57
67777-129-01XeroBurn Burn Gel6 in 1 BOXGEL67
67777-129-02XeroBurn Burn Gel3.5 g in 1 PACKETGEL3.57
67777-129-02XeroBurn Burn Gel1728 in 1 CASEGEL17287
67777-129-03XeroBurn Burn Gel113 g in 1 BOTTLEGEL1137
67777-129-09XeroBurn Burn Gel600 in 1 CASEGEL6007
67777-129-10XeroBurn Burn Gel600 in 1 CASEGEL6007
67777-129-11XeroBurn Burn Gel24 in 1 CASEGEL247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-129-00GM - Gram67777-129ad6333e5-81d5-4199-a4a3-d1dcc06fd7b712023-08-08
67777-129-01GM - Gram67777-129c6d48932-901b-42e4-96cc-057e477b881f12023-08-08
67777-129-02GM - Gram67777-129df8bd0be-f9a1-4758-bc3c-cd67991c063a12023-08-08
67777-129-09GM - Gram67777-129181880c5-e1e5-4a5a-a77f-bb8e504c174712023-08-08
67777-129-10GM - Gram67777-129e2f7c084-155a-4426-9cc2-eb977ee5bc9f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-129XEROBURN BURN GEL (LIDOCAINE HYDROCHLORIDE) GEL [DYNAREX CORPORATION]7Current NDC, Legacy NDC, 10 package rows20250316_58985046-ca9c-12be-e053-2991aa0abe72.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 74 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact identifier
application number: M017
Kalaya Extra Strength Pain Relief Cream with Hemp Seed OilMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp2eccf23c-fae2-423c-9cae-549bc41941042025-10-08WarningsExact identifier
application number: M017
KALAYA BACK AND NECK PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp48fd73e7-1443-4ac7-bf7c-d99bf2449f512025-10-08WarningsExact identifier
application number: M017
Lidocaine Pain Relieving PatchLIDOCAINE 4%BluePoint Laboratories3117273d-e006-2726-e063-6294a90a9c332025-10-08WarningsExact identifier
application number: M017
EQUATE PAIN RELIEVING PATCHESLIDOCAINE 4%WALMART, INC01e1cc0e-e1c9-d274-e063-6294a90a409e2025-10-08WarningsExact identifier
application number: M017
Equate Pain Relief BalmMENTHOL 11%, CAMPHOR 11% OINTMENTWALMART, INCd8ddf835-f008-ce1f-e053-2a95a90aa9b32025-10-08WarningsExact identifier
application number: M017
TheraCare Pain Relieving Menthol GelMENTHOL 2%Veridian Healthcare9d2ccb02-746c-4cb9-905d-280987778f4d2025-10-08WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC3a9019b1-8798-1ef9-e063-6394a90a09a42025-10-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN58985046-ca9c-12be-e053-2991aa0abe727
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD58985046-ca9c-12be-e053-2991aa0abe727
1011852lidocaine hydrochloride 2 % Topical JellySY58985046-ca9c-12be-e053-2991aa0abe727

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-129-006777701290025 PACKET in 1 BOX (67777-129-00) > 3.5 g in 1 PACKET25 packet2017-09-070000-00-00NoNoCurrent
67777-129-01677770129016 PACKET in 1 BOX (67777-129-01) > 3.5 g in 1 PACKET6 packet2017-09-070000-00-00NoNoCurrent
67777-129-02677770129021728 PACKET in 1 CASE (67777-129-02) / 3.5 g in 1 PACKET1728 packet2017-09-070000-00-00NoNoCurrent
67777-129-0367777012903113 g in 1 BOTTLE113 gHistorical
67777-129-0967777012909600 BOX in 1 CASE (67777-129-09) / 25 PACKET in 1 BOX (67777-129-00) / 3.5 g in 1 PACKET600 box2017-09-070000-00-00NoNoCurrent
67777-129-1067777012910600 BOX in 1 CASE (67777-129-10) / 6 PACKET in 1 BOX (67777-129-01) / 3.5 g in 1 PACKET600 box2017-09-070000-00-00NoNoCurrent
67777-129-116777701291124 BOTTLE in 1 CASE (67777-129-11) / 113 g in 1 BOTTLE (67777-129-03) 24 bottle2017-09-07NoNoCurrent