FDA.reportPublic FDA data

ELAIMEI Numbing Cream

Product NDC
83804-005
11-digit product format
838040005
Labeler code
83804
Product ID
83804-005_3cc30804-5c0f-8834-e063-6294a90a51ee
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine 4%
Dosage form
CREAM
Route
TOPICAL
Labeler
Shenzhen Shandian Jingling Technology Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-16
Substance
LIDOCAINE
Active strength
4 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

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
ELAIMEI Numbing Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1421893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
37ac13b2-ca55-0e28-e063-6294a90a000eAvailable 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
83804-005-01ELAIMEI Numbing Cream50 mL in 1 BOTTLECREAM507
83804-005-01ELAIMEI Numbing Cream1 in 1 BOXCREAM17

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 22 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
application number: M017
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
application number: M017
Feminine Anti Itch CreamBENZOCAINE,RESORCINOLTRIFECTA PHARMACEUTICALS USA LLC50c3acbf-b873-908a-e063-6294a90a66b72026-05-01WarningsExact identifier
application number: M017
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
application number: M017
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsExact identifier
application number: M017
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
application number: M017
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
application number: M017
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421893lidocaine 4 % Topical CreamPSN37ac13b2-ca55-0e28-e063-6294a90a000e7
1421893lidocaine 40 MG/ML Topical CreamSCD37ac13b2-ca55-0e28-e063-6294a90a000e7
1421893lidocaine 4 % Topical CreamSY37ac13b2-ca55-0e28-e063-6294a90a000e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83804-005-01838040005011 BOTTLE in 1 BOX (83804-005-01) / 50 mL in 1 BOTTLE1 bottle2025-06-16NoNoCurrent