Lidocaine Hydrochloride

Product NDC
61010-5100
11-digit product format
610105100
Labeler code
61010
Product ID
61010-5100_114b1a82-0728-fe2e-e063-6394a90a309e
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-02
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
20 mg/mL
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

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/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1010769

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-5100-4Lidocaine Hydrochloride59.1 mL in 1 BOTTLE, SPRAYLIQUID59.17
61010-5100-5Lidocaine Hydrochloride118 mL in 1 BOTTLE, SPRAYLIQUID1187

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ALIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
LidocaineACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
diazolidinyl ureaINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4
waterINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-5100LIDOCAINE HYDROCHLORIDE LIQUID [SAFETEC OF AMERICA, INC.]7Current NDC, Legacy NDC, 2 package rows20240214_8eb3e7e2-26e5-430e-89aa-40a0367c637e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010769lidocaine HCl 2 % Topical SprayPSN8eb3e7e2-26e5-430e-89aa-40a0367c637e7
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD8eb3e7e2-26e5-430e-89aa-40a0367c637e7
1010769lidocaine hydrochloride 2 % Topical SpraySY8eb3e7e2-26e5-430e-89aa-40a0367c637e7
1010769lidocaine HCl 2 % Topical SprayPSNf1f051ad-7e82-9d1a-e053-2a95a90ac7d33
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCDf1f051ad-7e82-9d1a-e053-2a95a90ac7d33
1010769lidocaine hydrochloride 2 % Topical SpraySYf1f051ad-7e82-9d1a-e053-2a95a90ac7d33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-5100-46101051000459.1 mL in 1 BOTTLE, SPRAY (61010-5100-4) 59.1 ml2011-08-020000-00-00NoNoCurrent
61010-5100-561010510005118 mL in 1 BOTTLE, SPRAY (61010-5100-5) 118 ml2011-08-020000-00-00NoNoCurrent