FDA.reportPublic FDA data

NDC 35781-0500 - 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
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 161 of 198 · 3,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL83c4928a-eea6-e176-e053-2991aa0a6bb12024-10-07WarningsExact identifier
unii: L7T10EIP3A
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Lc2340f56-9a8e-4eea-e053-2995a90a78fc2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La706ee9c-9ed0-d3f1-e053-2a95a90a26d62024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsMENTHOLTopco Associates LLCeff0b37b-6c08-b687-e053-2a95a90a11a92024-10-07WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
unii: L7T10EIP3A
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
unii: L7T10EIP3A
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
unii: L7T10EIP3A
HYSAN PAIN RELIEVERMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDbad73234-c204-40a8-8176-45c75ae500c82024-10-07WarningsExact identifier
unii: LAV5U5022Y
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
unii: 98PI200987
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
unii: L7T10EIP3A
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
unii: L7T10EIP3A
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
unii: 98PI200987
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
unii: L7T10EIP3A
HYSAN ANALGESICMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTD99a13b0a-1d77-479e-ba99-2cfa638de3392024-10-04WarningsExact identifier
unii: LAV5U5022Y
HYSAN HUO LU MEDICATEDMETHYL SALICYLATE, CAMPHOR (SYNTHETIC)HYSAN PHARMACEUTICAL CO LTDfe9eeaff-fcbf-4287-9f17-bcf1822bf35b2024-10-04WarningsExact identifier
unii: LAV5U5022Y

Reported adverse events (FAERS/openFDA)#

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