FDA.reportPublic FDA data

FSK-5

Product NDC
59898-170
11-digit product format
598980170
Labeler code
59898
Product ID
59898-170_5fc0e70e-35a7-6fdd-e053-2a91aa0ad0b3
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
KIT
Labeler
Water-Jel Technologies
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-11
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FSK-5
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1011852Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4c62196a-9f94-4823-b95f-447f012f10bfAvailable 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59898-170-43FSK-51 in 1 KITKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
LIDOCAINEACTIVE MOIETY98PI200987FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK31FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27EFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QSFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-170FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC, 1 package rows20171212_4c62196a-9f94-4823-b95f-447f012f10bf.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FSK-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies4c62196a-9f94-4823-b95f-447f012f10bf2017-12-07WarningsExact identifier
ndc (product): 59898-170

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011852lidocaine HCl 2 % Topical GelPSN4c62196a-9f94-4823-b95f-447f012f10bf5
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD4c62196a-9f94-4823-b95f-447f012f10bf5
1011852lidocaine hydrochloride 2 % Topical JellySY4c62196a-9f94-4823-b95f-447f012f10bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59898-170-43598980170431 KIT in 1 KIT (59898-170-43) * 25 PACKET in 1 CARTON (59898-200-15) / 3.5 mL in 1 PACKET (59898-200-35) 1 kit2014-06-110000-00-00NoNoCurrent