0.5% LIDOCAINE BURN RELIEF

Product NDC
43473-099
11-digit product format
434730099
Labeler code
43473
Product ID
43473-099_4b636475-c805-0b73-e063-6394a90ac7c9
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-21
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
.5 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
0.5% LIDOCAINE BURN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE.5 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
1011849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf723c7b-495d-4bae-942c-561cf28af2d3Available 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
43473-099-080.5% LIDOCAINE BURN RELIEF3 in 1 BOXGEL31
43473-099-080.5% LIDOCAINE BURN RELIEF226 g in 1 BOTTLE, PLASTICGEL2261

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 111 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Medicated Original Body Powder 10 ozMENTHOLVeridian Healthcare296b623a-14cd-0bca-e063-6394a90ac5ff2024-12-16WarningsExact identifier
application number: M017
HealthWise Medicated Extra Body Powder 10 ozMENTHOLVeridian Healthcare296c9a9c-e3db-59fe-e063-6294a90a0b622024-12-16WarningsExact identifier
application number: M017
Rite Aid Hot and Cold Roll OnMENTHOL 16%Rite Aidfc4b2635-280b-267f-e053-6294a90a5e222024-12-15WarningsExact identifier
application number: M017
Rite Aid Pain RelievingBENZOCAINE 20%, MENTHOL 0.5%Rite Aide2c09e85-be0a-4e6d-e053-2995a90ad7562024-12-15WarningsExact identifier
application number: M017
Rugby LidocaineLIDOCAINE 4%Rugby Laboratoriesd94292f7-10fc-48bf-e053-2995a90a84722024-12-15WarningsExact identifier
application number: M017
Rite Aid CortisoneHYDROCORTISONE 1%Rite Aide27353b9-23b6-3801-e053-2a95a90a60452024-12-15WarningsExact identifier
application number: M017
Rite Aid Cooling Pain ReliefMENTHOL 10.5%Rite Aide2225259-70ec-52de-e053-2a95a90a73f82024-12-15WarningsExact identifier
application number: M017
Rite Aid Rectal CareLIDOCAINE 5%Rite Aide283e462-96e8-04cf-e053-2a95a90a1d002024-12-15WarningsExact identifier
application number: M017
Rite Aid Anti-ItchDIPHENHYDRAMINE HCL 2%Rite Aide33898d8-1b8b-5c0b-e053-2995a90add082024-12-15WarningsExact identifier
application number: M017
Rite Aid Cala Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Rite Aide29a9d59-4c7c-81aa-e053-2995a90a70562024-12-15WarningsExact identifier
application number: M017
CVS Roll-OnCAPSAISIN 0.1%CVSe8812c49-335e-61ea-e053-2995a90a17aa2024-12-15WarningsExact identifier
application number: M017
Good Sense Burn Relief AloeLIDOCAINE HCLGeiss, Destin & Dunn, Incb5a7f629-a88d-b49d-e053-2995a90a49fa2024-12-15WarningsExact identifier
application number: M017
QC Burn Relief AloeLIDOCAINE HCLChain Drug Marketing Association Incb5e76f0c-0bfe-b13e-e053-2995a90a08612024-12-15WarningsExact identifier
application number: M017
Meijer Burn ReliefLIDOCAINE 0.5%Meijerbec60c93-5abd-ee04-e053-2a95a90acb612024-12-15WarningsExact identifier
application number: M017
QC Cool and Heat Roll-OnMENTHOL 16%Chain Drug Marketing Association Incd35e9dfa-8a28-fdb3-e053-2995a90abc522024-12-15WarningsExact identifier
application number: M017
Meijer Cold and Hot Pain RelievingMENTHOL 16%Meijerbec62df3-06c9-a115-e053-2995a90a42672024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain ReliefMENTHOL 16%Tommie Copper, Inc.b4dfa5fa-2d61-db1e-e053-2a95a90a7ac82024-12-15WarningsExact identifier
application number: M017
Pain Relief Liquid RollerCAMPHOR 3.5%, MENTHOL 3.5%Tommie Copper, Inc.c9f0447e-de43-16a5-e053-2995a90a05c12024-12-15WarningsExact identifier
application number: M017
Tommie Copper Pain Relief Maximum StrengthTROLAMINE SALICYLATE 10%Tommie Copper, Inc.b622c14f-9bf3-0bbd-e053-2a95a90a2adc2024-12-15WarningsExact identifier
application number: M017
Copperlife Pain ReliefTROLAMINE SALICYLATE 10%Tommie Copper, Inc.c94d00f9-42ce-1d43-e053-2a95a90a058d2024-12-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011849lidocaine HCl 0.5 % Topical GelPSNcf723c7b-495d-4bae-942c-561cf28af2d31
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCDcf723c7b-495d-4bae-942c-561cf28af2d31
1011849lidocaine hydrochloride 0.5 % Topical GelSYcf723c7b-495d-4bae-942c-561cf28af2d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43473-099-08434730099083 BOTTLE, PLASTIC in 1 BOX (43473-099-08) / 226 g in 1 BOTTLE, PLASTIC2026-02-21NoNoCurrent