FDA.reportPublic FDA data

Burn Mist

Product NDC
59898-201
11-digit product format
598980201
Labeler code
59898
Product ID
59898-201_4e590d19-e9bc-a8b3-e063-6294a90a64a1
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Water-Jel Technologies
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-05-17
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
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
Burn Mist
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2 g/100mL

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
1010769Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c53ab9dd-351a-400b-b873-4f396e0af54dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-201-10Burn Mist59 mL in 1 BOTTLE, SPRAYSPRAY598
59898-201-20Burn Mist24 in 1 CASESPRAY248

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ABURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
LIDOCAINEACTIVE MOIETY98PI200987BURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
OCTOXYNOL 9INACTIVE INGREDIENT7JPC6Y25QSBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4
WATERINACTIVE INGREDIENT059QF0KO0RBURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-201BURN MIST (LIDOCAINE HYDROCHLORIDE) SPRAY [WATER-JEL TECHNOLOGIES]7Current NDC, Legacy NDC, 2 package rows20250109_c53ab9dd-351a-400b-b873-4f396e0af54d.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 151 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEZhejiang Jingwei Pharmaceutical Co., Ltd.fefbe351-1cd9-4a2f-a43d-51e2c4eb180b2023-10-24WarningsExact identifier
application number: M017
TheraPlus PlusMENTHOLZhejiang Jingwei Pharmaceutical Co., Ltd.d4119f84-eb60-4134-b58e-de13d96011992023-10-24WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.cddc9c4a-7c58-4225-921a-05d6afb491782023-10-24WarningsExact identifier
application number: M017
NUMOTIZINEMENTHOLHobart Laboratories, Inc.9a29ad1b-4ba3-403f-90c9-ee7582fe45352023-10-20WarningsExact identifier
application number: M017
Numfast Tetracaine GreenTETRACAINEUnit Dose, Ltd.77d9e6ea-1cd3-4447-ba74-01cd7143e27c2023-10-19WarningsExact identifier
application number: M017
LiprotekPETROLATUM, LIDOCAINEUnit Dose, Ltd.051cfa27-bd7c-4f8c-b3e6-03ee0b7a3aa52023-10-19WarningsExact identifier
application number: M017
GENUINE FIRST AID Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.bc7c6739-6068-4694-adc9-0c0c5c347df42023-10-19WarningsExact identifier
application number: M017
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Asclemed USA, Inc.e13984ea-73a9-2894-e053-2995a90a8ed62023-10-16WarningsExact identifier
application number: M017
EXOTEN-CMETHYL SALICYLATE, MENTHOL, CAPSAICINAsclemed USA, Inc.76ed37e0-64b5-4abe-a03c-3dc7084a39192023-10-16WarningsExact identifier
application number: M017
Calypxo Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Incbd9d0bc0-5705-4c73-bcd6-f6cdb68e05b62023-10-16WarningsExact identifier
application number: M017
Calypxo HP Pain ReliefMETHYL SALICYLATE, MENTHOLAsclemed USA, Inc89a8c267-bd92-4d0d-8e50-c52224aff9cd2023-10-16WarningsExact identifier
application number: M017
ZylotrolLIDOCAINE HCL 4%, MENTHOL 1%Whitestone Products LLC0e32e9c0-ff5b-4e88-89b1-f5903cd982092023-10-16WarningsExact identifier
application number: M017
CapsadynCAPSAICINChorda Pharma, Inc07731045-0d2b-76b7-e063-6294a90af9212023-10-11WarningsExact identifier
application number: M017
WHITE FLOWER STRAIN RELIEFCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD65282267-de63-453a-a686-f8752c71b9ef2023-10-02WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALM FLORAL SCENTEDCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTD4e9cb5aa-b0aa-4a5c-b561-cc38437758d82023-10-02WarningsExact identifier
application number: M017
NATUREANCE BODY BALMCAMPHOREROS GLOBAL CORP05b84fd2-8d8f-9249-e063-6294a90ae29f2023-09-19WarningsExact identifier
application number: M017
U ICE COLDMENTHOLUNIVERSAL DISTRIBUTION CENTER LLC752ef0cd-f12a-3b9e-e053-2991aa0abeb12023-09-01WarningsExact identifier
application number: M017
Family Wellness Pain Relief with LidocainePAIN RELIEF WITH LIDOCAINEFAMILY DOLLAR (Family Wellness)3a18119f-6c75-4cea-a990-97cb8a9589d42023-08-29WarningsExact identifier
application number: M017
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010769lidocaine HCl 2 % Topical SprayPSNc53ab9dd-351a-400b-b873-4f396e0af54d8
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCDc53ab9dd-351a-400b-b873-4f396e0af54d8
1010769lidocaine hydrochloride 2 % Topical SpraySYc53ab9dd-351a-400b-b873-4f396e0af54d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-201-105989802011059 mL in 1 BOTTLE, SPRAY (59898-201-10) 59 ml2010-05-170000-00-00NoNoCurrent
59898-201-205989802012024 BOTTLE, SPRAY in 1 CASE (59898-201-20) / 59 mL in 1 BOTTLE, SPRAY (59898-201-10) 2010-05-17NoNoCurrent