FDA.reportPublic FDA data

Burn Jel

Product NDC
59898-200
11-digit product format
598980200
Labeler code
59898
Product ID
59898-200_2b0a5dfa-c7dd-d8e6-e063-6294a90ac37c
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Water-Jel Technologies
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-04-17
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
2 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

Additional Listing Data#

Finished product
Yes
Brand name base
Burn Jel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1011852

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59898-200-112023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-132023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-152023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-162023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-172023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-352023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-492023-03-14C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-112022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-132022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-152022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-162022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-172022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-352022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel
59898-200-492022-01-28C16284748780-1d6a99b39-eb3d-a426-e053-dadaa90af4c2Burn Jel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-200-10Burn Jel59 mL in 1 BOTTLE, PLASTICGEL595
59898-200-11Burn Jel24 in 1 CARTONGEL245
59898-200-12Burn Jel118 mL in 1 BOTTLE, PLASTICGEL1185
59898-200-13Burn Jel24 in 1 CARTONGEL245
59898-200-15Burn Jel3.5 mL in 1 PACKETGEL3.55
59898-200-15Burn Jel25 in 1 BOXGEL255
59898-200-16Burn Jel6 in 1 BOXGEL65
59898-200-16Burn Jel3.5 mL in 1 PACKETGEL3.55
59898-200-17Burn Jel3.5 mL in 1 PACKETGEL3.55
59898-200-17Burn Jel1728 in 1 CARTONGEL17285
59898-200-35Burn Jel3.5 mL in 1 PACKETGEL3.55
59898-200-49Burn Jel10 in 1 KITGEL105
59898-200-49Burn Jel3.5 mL in 1 PACKETGEL3.55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-200IWK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]8Current NDC, Legacy NDC20171212_f291841e-ccbd-4f5a-b1de-4cf596a167e3.zip
59898-200BURN JEL (LIDOCAINE HYDROCHLORIDE) GEL [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC, 13 package rows20250108_ff621b46-2342-41db-994d-851a09796d08.zip
59898-200EBSS-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC20171208_7e21b96a-3d89-4d1c-9ec6-0611f6c9c625.zip
59898-200FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC20171212_4c62196a-9f94-4823-b95f-447f012f10bf.zip
59898-200EBSL-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]3Current NDC, Legacy NDC20171212_0d2631c1-93fc-478c-afed-0f175a7e8555.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNf291841e-ccbd-4f5a-b1de-4cf596a167e38
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDf291841e-ccbd-4f5a-b1de-4cf596a167e38
1011852lidocaine hydrochloride 2 % Topical JellySYf291841e-ccbd-4f5a-b1de-4cf596a167e38
1011852lidocaine HCl 2 % Topical GelPSN4c62196a-9f94-4823-b95f-447f012f10bf5
1011852lidocaine HCl 2 % Topical GelPSN7e21b96a-3d89-4d1c-9ec6-0611f6c9c6255
1011852lidocaine HCl 2 % Topical GelPSNff621b46-2342-41db-994d-851a09796d085
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD4c62196a-9f94-4823-b95f-447f012f10bf5
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD7e21b96a-3d89-4d1c-9ec6-0611f6c9c6255
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDff621b46-2342-41db-994d-851a09796d085
1011852lidocaine hydrochloride 2 % Topical JellySY4c62196a-9f94-4823-b95f-447f012f10bf5
1011852lidocaine hydrochloride 2 % Topical JellySY7e21b96a-3d89-4d1c-9ec6-0611f6c9c6255
1011852lidocaine hydrochloride 2 % Topical JellySYff621b46-2342-41db-994d-851a09796d085
1011852lidocaine HCl 2 % Topical GelPSN0d2631c1-93fc-478c-afed-0f175a7e85553
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD0d2631c1-93fc-478c-afed-0f175a7e85553
1011852lidocaine hydrochloride 2 % Topical JellySY0d2631c1-93fc-478c-afed-0f175a7e85553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-200-105989802001059 mL in 1 BOTTLE, PLASTIC59 mlHistorical
59898-200-115989802001124 BOTTLE, PLASTIC in 1 CARTON (59898-200-11) / 59 mL in 1 BOTTLE, PLASTIC (59898-200-10) 2010-04-170000-00-00NoNoCurrent
59898-200-1259898020012118 mL in 1 BOTTLE, PLASTIC118 mlHistorical
59898-200-135989802001324 BOTTLE, PLASTIC in 1 CARTON (59898-200-13) / 118 mL in 1 BOTTLE, PLASTIC (59898-200-12) 2010-04-170000-00-00NoNoCurrent
59898-200-155989802001525 PACKET in 1 BOX (59898-200-15) / 3.5 mL in 1 PACKET25 packet2010-04-170000-00-00NoNoCurrent
59898-200-16598980200166 PACKET in 1 BOX (59898-200-16) / 3.5 mL in 1 PACKET6 packet2010-04-170000-00-00NoNoCurrent
59898-200-17598980200171728 PACKET in 1 CARTON (59898-200-17) / 3.5 mL in 1 PACKET1728 packet2010-04-170000-00-00NoNoCurrent
59898-200-35598980200353.5 mL in 1 PACKET (59898-200-35) 3.5 ml2010-04-170000-00-00NoNoCurrent
59898-200-495989802004910 PACKET in 1 KIT (59898-200-49) / 3.5 mL in 1 PACKET10 packet2010-04-170000-00-00NoNoCurrent