FDA.reportPublic FDA data

TOPICAINE

Product NDC
63135-312
11-digit product format
631350312
Labeler code
63135
Product ID
63135-312_47e8cec4-fde0-1956-e063-6394a90a1bdc
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE 4%
Dosage form
GEL
Route
TOPICAL
Labeler
ESBA LABORATORIES INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-04-20
Substance
LIDOCAINE
Active strength
4 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TOPICAINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1291672, 1651001

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63135-312-042024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-312-04TOPICAINE113 g in 1 TUBEGEL1135
63135-312-13TOPICAINE10 g in 1 TUBEGEL105
63135-312-13TOPICAINE1 in 1 BOXGEL15
63135-312-30TOPICAINE1 in 1 BOXGEL15
63135-312-30TOPICAINE30 g in 1 TUBEGEL305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-312-04GM - Gram63135-312477107f9-14e6-49b4-9bc3-5ba2f4b06dfc12015-06-09
63135-312-13GM - Gram63135-3124683b683-a1f1-476f-ba81-ec4e7d0df60912015-06-09
63135-312-30GM - Gram63135-3127cd93361-2de8-46e6-8d3e-cefdcf7482c712015-06-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63135-312TOPICAINE (LIDOCAINE 4%) GEL [ESBA LABORATORIES INC.]4Current NDC, Legacy NDC, 5 package rows20240922_7f96e980-891e-743d-e053-2a91aa0aea5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1291672lidocaine 4 % Topical GelPSN7f96e980-891e-743d-e053-2a91aa0aea5f5
1651001Topicaine 4 % Topical GelPSN7f96e980-891e-743d-e053-2a91aa0aea5f5
1651001lidocaine 0.04 MG/MG Topical Gel [Topicaine]SBD7f96e980-891e-743d-e053-2a91aa0aea5f5
1291672lidocaine 0.04 MG/MG Topical GelSCD7f96e980-891e-743d-e053-2a91aa0aea5f5
1291672lidocaine 4 % Topical GelSY7f96e980-891e-743d-e053-2a91aa0aea5f5
1651001Topicaine 4 % Topical GelSY7f96e980-891e-743d-e053-2a91aa0aea5f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63135-312-0463135031204113 g in 1 TUBE (63135-312-04) 113 g2003-04-200000-00-00NoNoCurrent
63135-312-13631350312131 TUBE in 1 BOX (63135-312-13) / 10 g in 1 TUBE1 tube2003-04-200000-00-00NoNoCurrent
63135-312-30631350312301 TUBE in 1 BOX (63135-312-30) / 30 g in 1 TUBE1 tube2003-04-200000-00-00NoNoCurrent