FDA.reportPublic FDA data

Lidocaine

Product NDC
39328-024
11-digit product format
393280024
Labeler code
39328
Product ID
39328-024_3f0fe203-1ea7-4cdb-ad5e-b14f0740e9f1
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Patrin Pharma Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-01
Substance
LIDOCAINE
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
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 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 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
91eedf9d-53b8-49d5-af59-25019606a0b2Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
39328-024-15Lidocaine15 g in 1 TUBECREAM153
39328-024-15Lidocaine1 in 1 CARTONCREAM13
39328-024-30Lidocaine1 in 1 CARTONCREAM13
39328-024-30Lidocaine30 g in 1 TUBECREAM303
39328-024-55Lidocaine5 in 1 CARTONCREAM53
39328-024-55Lidocaine5 g in 1 TUBECREAM53
39328-024-56Lidocaine5 in 1 CARTONCREAM53
39328-024-56Lidocaine5 g in 1 TUBECREAM53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-024-15GM - Gram39328-02409e9a1cb-1849-4eda-a51f-44a57c140fa812019-01-24
39328-024-30GM - Gram39328-024969e2fc4-f4e2-4d0a-8998-246081561f3112019-01-24
39328-024-55GM - Gram39328-0248dda2cba-ba47-45dd-9fe5-b9e637fd929212019-01-24
39328-024-56EA - Each39328-02416386988-efdf-4d26-8894-7363ee4d47ee12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-024LIDOCAINE CREAM [PATRIN PHARMA INC.]3Current NDC, Legacy NDC, 8 package rows20241121_91eedf9d-53b8-49d5-af59-25019606a0b2.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 139 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cfde0-c463-e9b5-e053-2a95a90a19242024-01-15WarningsExact identifier
application number: M017
American Safety and First AidHYDROCORTISONE ACETATEOrazen Inceb0cce4b-c70a-1b2d-e053-2995a90aa4aa2024-01-15WarningsExact identifier
application number: M017
Oral Pain Relief GelBENZOCAINE 20%Sled Distribution, LLCe7391302-831e-14dc-e053-2a95a90ac2362024-01-15WarningsExact identifier
application number: M017
FIRST SHIELDLIDOCAINE HCIEver Ready First Aide022bf8f-3dd8-de22-e053-2995a90a219b2024-01-15WarningsExact identifier
application number: M017
FlexigenMENTHOL 1.25%Derma Care Research Labs, LLCe9ae2682-59b4-e796-e053-2995a90af9212024-01-15WarningsExact identifier
application number: M017
Vita-P Oral and NasalMENTHOL 1%Beijing HKKY Medical Tech. Co., Ltd.537c3843-1c92-41c6-b724-52701bbddeab2024-01-13WarningsExact identifier
application number: M017
Caring mill Lidocaine Aloe Gel Burn and Pain ReliefLIDOCAINE HYDROCHLORIDEFSA Store Inc.0ec20c87-1681-dd23-e063-6394a90a291c2024-01-12WarningsExact identifier
application number: M017
Cool n HeatCOOL N HEATNeilMed Pharmaceuticals, Inc.a24cde17-280b-8358-e053-2a95a90af67d2024-01-11WarningsExact identifier
application number: M017
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
application number: M017
NeilMed Hot and Cold Pain ReliefPAIN RELIEF SPRAYNeilMed Pharmaceuticals Inc.b3d02111-7499-c2d4-e053-2a95a90ae1de2024-01-11WarningsExact identifier
application number: M017
Cooling Itch ReliefCOOLING ITCH RELIEFNeilMed Pharmaceuticals, Inca24bdea0-18e8-8a5e-e053-2995a90acea22024-01-11WarningsExact identifier
application number: M017
Lightning X BurnLIDOCAINENantong Health & Beyond Hygienic Products Inc.0e69a971-0c6e-6ebe-e063-6394a90a0b332024-01-08WarningsExact identifier
application number: M017
Theraworx Pain Relief Roll-On with Lidocaine for DiabeticsLIDOCAINE HYDROCHLORIDEAVADIM HOLDINGS, INC.e07f5bf7-5a9a-468c-8c3f-2c6f0b17af292024-01-08WarningsExact identifier
application number: M017
2nd CHANCE MOBILITY Pain ReliefHISTAMINE DIHYDROCHLORIDEALPHA NUTRITION, LLC575097ac-9fc9-4391-99d1-dff9b34817e32024-01-08WarningsExact identifier
application number: M017
Tiger Balm Arthritis RubCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMHaw Par Healthcare Ltd.80932288-4797-40d3-aa8a-6af686fb67ad2024-01-08WarningsExact identifier
application number: M017
OPRAVAMETHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC05552560-e283-5eba-e063-6294a90a65f72024-01-06WarningsExact identifier
application number: M017
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421893lidocaine 4 % Topical CreamPSN91eedf9d-53b8-49d5-af59-25019606a0b23
1421893lidocaine 40 MG/ML Topical CreamSCD91eedf9d-53b8-49d5-af59-25019606a0b23
1421893lidocaine 4 % Topical CreamSY91eedf9d-53b8-49d5-af59-25019606a0b23
1421893lidocaine 4 % Topical CreamPSN01cb19a4-ce22-144d-e063-6294a90a8aa32
1421893lidocaine 40 MG/ML Topical CreamSCD01cb19a4-ce22-144d-e063-6294a90a8aa32
1421893lidocaine 4 % Topical CreamSY01cb19a4-ce22-144d-e063-6294a90a8aa32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39328-024-15393280024151 TUBE in 1 CARTON (39328-024-15) / 15 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
39328-024-30393280024301 TUBE in 1 CARTON (39328-024-30) / 30 g in 1 TUBE1 tube2018-11-010000-00-00NoNoCurrent
39328-024-55393280024555 TUBE in 1 CARTON (39328-024-55) / 5 g in 1 TUBE5 tube2018-11-010000-00-00NoNoCurrent
39328-024-56393280024565 TUBE in 1 CARTON (39328-024-56) / 5 g in 1 TUBE5 tube2018-11-010000-00-00NoNoCurrent