FDA.reportPublic FDA data

Bio-Scriptives Lidum Topical Analgesic

Product NDC
60608-017
11-digit product format
606080017
Labeler code
60608
Product ID
60608-017_fa228065-45fa-40fe-8057-18c69a1b8394
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bio-Scriptives, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-03-07
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
3 g/56g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
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
60608-017-012019-11-13C16284748780-197449f38-d5f8-f6ea-e053-dbdaa90aa703Bio-Scriptives Lidum (Lidocaine 4%) Topical Analgesic
60608-017-032019-11-13C16284748780-197449f38-d5f8-f6ea-e053-dbdaa90aa703Bio-Scriptives Lidum (Lidocaine 4%) Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60608-017-00Bio-Scriptives Lidum Topical Analgesic56 g in 1 TUBECREAM562
60608-017-01Bio-Scriptives Lidum Topical Analgesic1 in 1 BOXCREAM12
60608-017-02Bio-Scriptives Lidum Topical Analgesic4.5 g in 1 TUBECREAM4.52
60608-017-03Bio-Scriptives Lidum Topical Analgesic15 in 1 BOXCREAM152

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ALLANTOININACTIVE INGREDIENT344S277G0ZBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ARGININE HYDROCHLORIDEINACTIVE INGREDIENTF7LTH1E20YBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ETHYL OLEATEINACTIVE INGREDIENTZ2Z439864YBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4NBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
METHYL NICOTINATEINACTIVE INGREDIENT7B1AVU9DJNBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFABIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ABIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
TOCOPHERSOLANINACTIVE INGREDIENTO03S90U1F2BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2
xanthan gumINACTIVE INGREDIENTTTV12P4NEEBIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60608-017BIO-SCRIPTIVES LIDUM TOPICAL ANALGESIC (LIDOCAINE) CREAM [BIO-SCRIPTIVES, INC.]2Legacy NDC, 4 package rows20120312_a19bb9cc-b20b-4a15-9c82-dd2544cb252d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
60608-017-006060800170056 g in 1 TUBE56 gHistorical
60608-017-01606080017011 in 1 BOXHistorical
60608-017-02606080017024.5 g in 1 TUBE4.5 gHistorical
60608-017-036060800170315 in 1 BOXHistorical