FDA.reportPublic FDA data

NDC 35781-0500-9 - WPR Plus

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
35781-0500
Requested NDC
35781-0500-9
Package NDCs from labels
35781-0500-3, 35781-0500-1, 35781-0500-9
Manufacturer
International Brand Management, LLC | Gensco Laboratories, LLC
Effective date
2018-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WPR Plus - International Brand Management, LLC | Gensco Laboratories, LLCInternational Brand Management, LLC | Gensco Laboratories, LLC2018-07-17HUMAN PRESCRIPTION DRUG LABEL
WPR Plus - International Brand Management, LLCInternational Brand Management, LLC2018-07-17HUMAN OTC DRUG LABEL
Lidocaine Hydrochloride - Gensco Laboratories, LLCGensco Laboratories, LLC2015-10-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35781-0500-12020-01-31C16284748780-19d75b9d0-d18c-f424-e053-dadaa90a57ceLDO Plus (Lidocaine HCl USP) 4%
35781-0500-32020-01-31C16284748780-19d75b9d0-d18c-f424-e053-dadaa90a57ceLDO Plus (Lidocaine HCl USP) 4%
35781-0500-92020-01-31C16284748780-19d75b9d0-d18c-f424-e053-dadaa90a57ceLDO Plus (Lidocaine HCl USP) 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0500-3WPR Plus30 g in 1 TUBE30 g40 mg in 1g2
35781-0500-1Lidocaine Hydrochloride15 g in 1 TUBEGEL151
35781-0500-1Lidocaine Hydrochloride1 in 1 CARTONGEL11
35781-0500-3WPR Plus30 g in 1 TUBE30 g40 mg in 1g1
35781-0500-3Lidocaine Hydrochloride1 in 1 CARTONGEL11
35781-0500-3Lidocaine Hydrochloride30 g in 1 TUBEGEL301
35781-0500-9Lidocaine Hydrochloride1 in 1 CARTONGEL11
35781-0500-9Lidocaine Hydrochloride90 g in 1 TUBEGEL901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35781-0500WPR PLUS () KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]2Unmatched20180801_9d830535-2202-482d-9d1a-bccd7bbba855.zip
35781-0500LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]16 package rows20151028_88dbd438-02c0-481a-bdb7-8b3f3c41fd46.zip
35781-0500WPR PLUS () KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]1Unmatched20180717_793d6fad-31a7-4b28-8395-73825bc18508.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0500-3ML - Milliliter35781-0500e34c830a-ebae-4476-af71-631a4ac662bc12015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
FILIPENDULA ULMARIA FLOWERINACTIVE INGREDIENT06L18L32G6LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
QUERCUS ALBA WOODINACTIVE INGREDIENTXR6BC2ZUAMLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1
ZINC ACETATEINACTIVE INGREDIENTFM5526K07ALIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]1

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 47 of 198 · 3,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFIcce74940-ebf1-4fa4-9ef4-50619704d5cd2026-02-16Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
unii: 98PI200987
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
unii: L7T10EIP3A
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Clear Anti ItchPRAMOXINE HCL, ZINC ACETATETopco Associates LLC8d3d1ff5-4868-495d-807c-e45aa2176f632026-02-13Warnings, Adverse reactionsExact identifier
unii: FM5526K07A
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTopco Associates LLC62eed0e8-ba5f-45c2-a543-68b50bcf4b0c2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Original AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCb6c8d5b1-4b19-463c-826a-cccdcec09e2d2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC24b19a98-143d-4634-b2b3-4d02dfd579872026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCa1915524-2719-40d4-86e3-35df5ce3238d2026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC0d97cb54-1b9c-4aff-a15c-3bf9b66782092026-02-13Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
unii: FM5526K07A
LidocaineLIDOCAINEA-S Medication Solutions82bb7767-5407-4593-b6d4-90859890e3762026-02-12Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
unii: 98PI200987
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
unii: ZY81Z83H0X
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC2022986a-2a93-4291-887c-c23f2b2c83a72026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC4ad7818e-caee-49f0-81e8-bda6fbd64ea52026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLCef20af6a-4547-4b63-8ffe-989112e3030f2026-02-12Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.