FDA.reportPublic FDA data

LidoStat

Product NDC
44577-704
11-digit product format
445770704
Labeler code
44577
Product ID
44577-704_0973ba09-954a-0fb9-e063-6294a90a4d13
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Clinical Therapeutic Solutions
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-06-19
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
40 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
LidoStat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010895Internal RxNorm lookup
1427002Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1825885b-9141-4515-bb69-a1c4a39fb10dAvailable 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
44577-704-02LidoStat1 in 1 CARTONCREAM15
44577-704-02LidoStat56 g in 1 TUBECREAM565

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
DIMETHYL SULFONEINACTIVE INGREDIENT9H4PO4Z4FTLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
UREAINACTIVE INGREDIENT8W8T17847WLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44577-704LIDOSTAT (LIDOCAINE HCL) CREAM [CLINICAL THERAPEUTIC SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231106_1825885b-9141-4515-bb69-a1c4a39fb10d.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 67 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIAN LI ZHUI FENG PAIN RELIEVINGCAMPHOR, MENTHOL, AND METHYL SALICYLATEMADISON ONE ACME INC03a4fb7c-2328-409d-99c8-cbcf2b4a451f2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATEDMENTHOL AND CAMPHORMADISON ONE ACME INC05c6b95a-aeb6-4234-97c7-8d77eccb38d82025-11-10WarningsExact identifier
application number: M017
HEI GUI PAIN RELIEVINGCAMPHOR AND METHYL SALICYLATEMADISON ONE ACME INC4140c404-edab-4923-941d-f74125e943a92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INCddcc814e-fcc4-4232-9ab4-826b8aac35f02025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
OvertimeMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.25fec070-8587-42d1-ba6f-1a9c150acc982025-11-10WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.05742cd5-ece2-4007-bdf0-46b76d23df742025-11-10WarningsExact identifier
application number: M017
Anal BluDESENSITIZERNovelties by Nasswalk, Inc.03b9555b-c3ff-4baa-e063-6394a90afb2c2025-11-10WarningsExact identifier
application number: M017
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1825885b-9141-4515-bb69-a1c4a39fb10d5
1427002Lidostat 4 % Topical CreamPSN1825885b-9141-4515-bb69-a1c4a39fb10d5
1427002lidocaine hydrochloride 40 MG/ML Topical Cream [Lidostat]SBD1825885b-9141-4515-bb69-a1c4a39fb10d5
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1825885b-9141-4515-bb69-a1c4a39fb10d5
1010895lidocaine hydrochloride 4 % Topical CreamSY1825885b-9141-4515-bb69-a1c4a39fb10d5
1427002Lidostat 4 % Topical CreamSY1825885b-9141-4515-bb69-a1c4a39fb10d5
1427002Lidostat 40 MG/ML Topical CreamSY1825885b-9141-4515-bb69-a1c4a39fb10d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44577-704-02445770704021 TUBE in 1 CARTON (44577-704-02) / 56 g in 1 TUBE1 tube2017-02-070000-00-00NoNoCurrent