FDA.reportPublic FDA data

TOPICAINE 5

Product NDC
63135-581
11-digit product format
631350581
Labeler code
63135
Product ID
63135-581_47e9cb0c-dbdb-3ee0-e063-6394a90a9052
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE 5%
Dosage form
GEL
Route
TOPICAL
Labeler
ESBA LABORATORIES INC.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-04-20
Substance
LIDOCAINE
Active strength
5 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 5
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1652104, 1652108

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-581-04TOPICAINE 5113 g in 1 TUBEGEL11311
63135-581-10TOPICAINE 51 in 1 BOXGEL111
63135-581-10TOPICAINE 510 g in 1 TUBEGEL1011
63135-581-30TOPICAINE 530 g in 1 TUBEGEL3011
63135-581-30TOPICAINE 51 in 1 BOXGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-581-04GM - Gram63135-581516d8cdc-b0b9-41d0-a09e-16adb6e54e5512015-06-09
63135-581-10GM - Gram63135-58152ce08c1-dd51-40ca-ac6b-e384ded7cd4112022-06-06
63135-581-30GM - Gram63135-581327039a8-0a8b-4662-a224-14eee8dc7f7712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987TOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
LIDOCAINEACTIVE MOIETY98PI200987TOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VCTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ETOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
GLYCERYL LAURATEINACTIVE INGREDIENTY98611C087TOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YTOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63135-581TOPICAINE 5 (LIDOCAINE 5%) GEL [ESBA LABORATORIES INC.]10Current NDC, Legacy NDC, 5 package rows20240921_15d33ff7-34ed-253d-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1652104lidocaine 5 % Rectal GelPSN15d33ff7-34ed-253d-e054-00144ff88e8811
1652108Topicaine-5 5 % Rectal GelPSN15d33ff7-34ed-253d-e054-00144ff88e8811
1652108lidocaine 0.05 MG/MG Rectal Gel [Topicaine]SBD15d33ff7-34ed-253d-e054-00144ff88e8811
1652104lidocaine 0.05 MG/MG Rectal GelSCD15d33ff7-34ed-253d-e054-00144ff88e8811
1652104lidocaine 5 % Rectal GelSY15d33ff7-34ed-253d-e054-00144ff88e8811
1652108Topicaine 0.05 MG/MG Rectal GelSY15d33ff7-34ed-253d-e054-00144ff88e8811
1652108Topicaine-5 5 % Rectal GelSY15d33ff7-34ed-253d-e054-00144ff88e8811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63135-581-0463135058104113 g in 1 TUBE (63135-581-04) 113 g2008-03-010000-00-00NoNoCurrent
63135-581-10631350581101 TUBE in 1 BOX (63135-581-10) / 10 g in 1 TUBE1 tube2003-04-200000-00-00NoNoCurrent
63135-581-13631350581131 TUBE in 1 BOX (63135-581-13) > 10 g in 1 TUBE1 tube2003-04-200000-00-00NoNoCurrent
63135-581-30631350581301 TUBE in 1 BOX (63135-581-30) / 30 g in 1 TUBE1 tube2003-04-200000-00-00NoNoCurrent