FDA.reportPublic FDA data

JJ Care BURN

Product NDC
43473-069
Requested package NDC
43473-069-02
11-digit product format
434730069
Labeler code
43473
Product ID
43473-069_55bca04a-98d6-3ed7-e063-6394a90acb74
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Nantong Health & Beyond Hygienic Products Inc.
Application
M0017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-19
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
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
JJ Care BURN
Listing expiration
2027-12-31

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
d69ebc53-8552-449a-a973-f211328a3d3eAvailable 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
43473-069-01JJ Care BURN0.9 g in 1 PACKETGEL0.91
43473-069-02JJ Care BURN160 in 1 PACKAGEGEL1601
43473-069-02JJ Care BURN0.9 g in 1 PACKETGEL0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43473-069JJ CARE BURN (LIDOCAINE HYDROCHLORIDE) GEL [NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.]1Current NDC, 3 package rows20250221_d69ebc53-8552-449a-a973-f211328a3d3e.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JJ Care BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.d69ebc53-8552-449a-a973-f211328a3d3e2026-07-03WarningsExact identifier
application number: M0017
ndc (package): 43473-069-02
ndc (product): 43473-069
ndc11 (package): 43473006902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSNd69ebc53-8552-449a-a973-f211328a3d3e1
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCDd69ebc53-8552-449a-a973-f211328a3d3e1
1011852lidocaine hydrochloride 2 % Topical JellySYd69ebc53-8552-449a-a973-f211328a3d3e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43473-069-0243473006902160 PACKET in 1 PACKAGE (43473-069-02) / .9 g in 1 PACKET160 packet2025-02-19NoNoCurrent