FDA.reportPublic FDA data

Bio-Scriptives Lidum Hemorroidal (Anorectal)

Product NDC
60608-016
11-digit product format
606080016
Labeler code
60608
Product ID
60608-016_25174fb2-87a8-4a29-96f8-e0fd452b5971
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bio-Scriptives, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-04
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
3 g/56g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
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
60608-016-012019-11-13C16284748780-197449f38-d41b-f6ea-e053-dbdaa90aa703Bio-Scriptives Lidum (Lidocaine 5%) Hemorroidal (Anorectal) Cream
60608-016-032019-11-13C16284748780-197449f38-d41b-f6ea-e053-dbdaa90aa703Bio-Scriptives Lidum (Lidocaine 5%) Hemorroidal (Anorectal) Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60608-016-00Bio-Scriptives Lidum Hemorroidal (Anorectal)56 g in 1 TUBECREAM562
60608-016-01Bio-Scriptives Lidum Hemorroidal (Anorectal)1 in 1 BOXCREAM12
60608-016-02Bio-Scriptives Lidum Hemorroidal (Anorectal)4.5 g in 1 TUBECREAM4.52
60608-016-03Bio-Scriptives Lidum Hemorroidal (Anorectal)15 in 1 BOXCREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60608-016BIO-SCRIPTIVES LIDUM HEMORROIDAL (ANORECTAL) (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2Legacy NDC, 4 package rows20120312_3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436083Bio-Scriptives Lidum 5 % Rectal CreamPSN3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1366789lidocaine 5 % Rectal CreamPSN3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1436083lidocaine 50 MG/ML Rectal Cream [Lidum]SBD3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1366789lidocaine 50 MG/ML Rectal CreamSCD3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1436083Bio-Scriptives Lidum 5 % Rectal CreamSY3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1366789lidocaine 5 % Rectal CreamSY3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1436083Lidum 5 % Rectal CreamSY3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032
1436083Lidum 50 MG/ML Rectal CreamSY3bdd28f6-b6c3-4fef-ae05-fc0cc1fc5f032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60608-016-006060800160056 g in 1 TUBE56 gHistorical
60608-016-01606080016011 in 1 BOXHistorical
60608-016-02606080016024.5 g in 1 TUBE4.5 gHistorical
60608-016-036060800160315 in 1 BOXHistorical