FDA.reportPublic FDA data

Lidocaine Hydrochloride

Product NDC
61010-5000
11-digit product format
610105000
Labeler code
61010
Product ID
61010-5000_10d33035-4a33-6917-e063-6294a90ac896
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
GEL
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-19
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 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
Lidocaine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE20 mg/g

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
1c5eb3b3-79b3-472a-ae36-ec6a7dc72925Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61010-5000-02024-02-0761010-5000, Burn Gel
61010-5000-12024-02-0761010-5000, Burn Gel
61010-5000-32024-02-0761010-5000, Burn Gel
61010-5000-42024-02-0761010-5000, Burn Gel
61010-5000-52024-02-0761010-5000, Burn Gel
61010-5000-62024-02-0761010-5000, Burn Gel
61010-5000-02024-01-3061010-5000, Burn Gel
61010-5000-12024-01-3061010-5000, Burn Gel
61010-5000-32024-01-3061010-5000, Burn Gel
61010-5000-42024-01-3061010-5000, Burn Gel
61010-5000-52024-01-3061010-5000, Burn Gel
61010-5000-62024-01-3061010-5000, Burn Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5000-0Lidocaine Hydrochloride3.3 g in 1 PACKETGEL3.35
61010-5000-1Lidocaine Hydrochloride121.2 g in 1 BOTTLEGEL121.25
61010-5000-3Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-4Lidocaine Hydrochloride144 in 1 CARTONGEL1445
61010-5000-4Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-5Lidocaine Hydrochloride0.9 g in 1 POUCHGEL0.95
61010-5000-5Lidocaine Hydrochloride25 in 1 CARTONGEL255
61010-5000-6Lidocaine Hydrochloride0.9 g in 1 PACKETGEL0.95
61010-5000-6Lidocaine Hydrochloride10 in 1 BOXGEL105

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
mentholINACTIVE INGREDIENTL7T10EIP3ALIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
trolamineINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5000LIDOCAINE HYDROCHLORIDE GEL [SAFETEC OF AMERICA, INC.]5Current NDC, Legacy NDC, 9 package rows20240208_1c5eb3b3-79b3-472a-ae36-ec6a7dc72925.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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN1c5eb3b3-79b3-472a-ae36-ec6a7dc729255
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD1c5eb3b3-79b3-472a-ae36-ec6a7dc729255
1011852lidocaine hydrochloride 2 % Topical JellySY1c5eb3b3-79b3-472a-ae36-ec6a7dc729255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5000-0610105000003.3 g in 1 PACKET (61010-5000-0) 3.3 g2012-09-190000-00-00NoNoCurrent
61010-5000-161010500001121.2 g in 1 BOTTLE (61010-5000-1) 121.2 g2012-09-190000-00-00NoNoCurrent
61010-5000-361010500003.9 g in 1 POUCH (61010-5000-3) 2012-09-190000-00-00NoNoCurrent
61010-5000-461010500004144 POUCH in 1 CARTON (61010-5000-4) / .9 g in 1 POUCH144 pouch2012-09-190000-00-00NoNoCurrent
61010-5000-56101050000525 POUCH in 1 CARTON (61010-5000-5) / .9 g in 1 POUCH25 pouch2012-09-190000-00-00NoNoCurrent
61010-5000-66101050000610 PACKET in 1 BOX (61010-5000-6) / .9 g in 1 PACKET10 packet2020-04-010000-00-00NoNoCurrent