FDA.reportPublic FDA data

Signature numbing cream

Product NDC
84019-033
11-digit product format
840190033
Labeler code
84019
Product ID
84019-033_3d3b771f-5e31-b23e-e063-6294a90a3fb2
Type
HUMAN OTC DRUG
Nonproprietary name
5% Lidocaine
Dosage form
CREAM
Route
RECTAL
Labeler
Shengnan (Guangzhou) Cosmetics Co., LTD
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-26
Substance
LIDOCAINE
Active strength
100 mg/g
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
Signature numbing cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE100 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d3b771f-5e30-b23e-e063-6294a90a3fb2Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84019-033-01Signature numbing cream10 g in 1 BOTTLECREAM101

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 11 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Adellina Lidocaine Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.41a6d309-2722-1738-e063-6294a90a8a702025-10-21WarningsExact identifier
application number: M015
DERMOSCRIBE ICHYBUMHYDROCORTISONE, CLIOQUINOL, ZINC OXIDEDERMOSCRIBE PTY LTD134a88a1-13e5-4da0-8270-c380b57aaeb72025-10-17WarningsExact identifier
application number: M015
MedlineMENTHOL, WHITE PETROLATUM, ZINC OXIDEMedline Industries, LP006539c9-1982-d6de-e063-6294a90a1a5a2025-10-17WarningsExact identifier
application number: M015
Xesso Strawberry Rear Comfort Glide 4% LidocaineLIDOCAINEPremium Natural Cosmetics Incefba09fc-6dd7-0f73-e053-2995a90a628a2025-10-17WarningsExact identifier
application number: M015
medicated padsWITCH HAZELTARGET CORPORATIONacd0d99d-2a77-4227-bebb-c819f4a526662025-10-14WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b0e8d6-4686-960b-e063-6294a90a016e2025-10-09WarningsExact identifier
application number: M015
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.40b452a3-76b7-2433-e063-6294a90ab6b42025-10-09WarningsExact identifier
application number: M015
EQUATE HEMORRHOID RELIEFLIDOCAIN 5%WALMART, INCd96e8152-e36e-22fc-e053-2995a90a8b2b2025-10-08WarningsExact identifier
application number: M015
Pramoxine Hydrochloride AnorectalPRAMOXINE HYDROCHLORIDEStratus Pharmaceuticals39a16b66-b0e9-412f-8773-8dec0a1227e02025-10-02WarningsExact identifier
application number: M015
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
application number: M015
RWWXII Deep Numbing Cream(Anorectal Hemorrhoidal Cream)LIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.3ffc57c7-5bf4-cba8-e063-6394a90a322f2025-09-29WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF CREAMNeilmed Pharmaceuticals Inc.374dc1c0-4243-b272-e063-6394a90a5a6b2025-09-24WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation44bb5f25-1114-4bb1-8bcf-40402594abc42025-09-09WarningsExact identifier
application number: M015
Dr. Care Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3e456af7-9726-d17e-e063-6394a90ab5602025-09-08WarningsExact identifier
application number: M015
Medi-first Ivy-Rid First AidBENZOCAINE AND BENZETHONIUM CHLORIDEUnifirst First Aid Corporation905c97ad-0bba-46b1-939c-f16fbdb028182025-09-08WarningsExact identifier
application number: M015
MediFirst BurnLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation9fa5b348-29c2-4cd0-a945-0486bd27f5e02025-09-08WarningsExact identifier
application number: M015
Medi-First BurnLIDOCAINE HCLUnifirst First Aid Corporationb3ebf104-cc51-0ef5-e053-2a95a90a25c92025-09-08WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEUnifirst First Aid Corporation4c2e2b91-d2f6-4e41-9a4c-ecabca9830e82025-09-08WarningsExact identifier
application number: M015
Pain ReliefANALGESIC MENTHOLUnifirst First Aid Corporation8162d22d-04c0-de07-e053-2991aa0a99752025-09-08WarningsExact identifier
application number: M015
Green Guard BurnLIDOCAINE HCLUnifirst First Aid Corporationb451e96f-fcba-6495-e053-2a95a90a2adf2025-09-08WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84019-033-018401900330110 g in 1 BOTTLE (84019-033-01) 10 g2025-08-26NoNoCurrent