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 196 of 197 · 3,939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Cadira Compliant Blood StatLIDOCAINE / PRILOCAINEAsclemed USA, Inc.79a31029-c221-4a4c-8dd9-bf78cbf2a16a2018-11-01Warnings, Adverse reactionsExact identifier
unii: 98PI200987
LIDO BDKLIDOCAINE, PRILOCAINEAsclemed USA, Inc.51fd0589-e551-4583-98e1-1e8db19d7e6d2018-11-01Warnings, Adverse reactionsExact identifier
unii: 98PI200987
LidocaineLIDOCAINEAmneal Pharmaceuticals LLCd1509740-f9f1-44e3-8fde-51d8683fcd872018-10-28Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Fast FreezeCAMPHOR (NATURAL), MENTHOLNatural Essentials Inc.60c94da8-6c00-4544-a9a6-a3e87ebabd682018-10-18WarningsExact identifier
unii: L7T10EIP3A
AnalgesicMENTHOLSafetec of America, Inc.a90266d4-1e71-4805-aeca-6f8ed45135bb2018-10-01WarningsExact identifier
unii: L7T10EIP3A
COLD LEAF NUTRITION MUSCLE AND JOINT PAIN RELIEFMENTHOLNATURAL ESSENTIALS, INC.9fcc79e6-8176-4ebc-8602-0649b02fab862018-09-27WarningsExact identifier
unii: L7T10EIP3A
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: OJ245FE5EU
0e93c583-0f3f-4e75-a259-d16c279dc782793d6fad-31a7-4b28-8395-73825bc185082018-07-17Warnings, Adverse reactionsExact identifier
spl id: 0e93c583-0f3f-4e75-a259-d16c279dc782
spl set id: 793d6fad-31a7-4b28-8395-73825bc18508
17727159-0bd7-4fa0-8240-d6463cbfd0aa9d830535-2202-482d-9d1a-bccd7bbba8552018-07-17Warnings, Adverse reactionsExact identifier
spl id: 17727159-0bd7-4fa0-8240-d6463cbfd0aa
spl set id: 9d830535-2202-482d-9d1a-bccd7bbba855
Pure-AidCAMPHOR, MENTHOL, METHYL SALICYLATEKareway Product, Inc.6def9da7-e118-fd5c-e053-2991aa0a65d22018-06-05WarningsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
SoundbodyLIDOCAINE, MENTHOLKareway Product, Inc.6c83ec36-3e3d-07a9-e053-2a91aa0ac54c2018-05-18WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
Avedana Cool Hot IceMENTHOLUnipack, Inc.619c8e3f-0cad-4eb1-8dbb-632f3db74ba32018-05-01WarningsExact identifier
unii: L7T10EIP3A
Pure-AidLIDOCAINE, MENTHOLKareway Product, Inc.6679cada-f083-26e8-e053-2a91aa0adcc52018-03-02WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A
Ivy-Dry SuperBENZYL ALCOHOL, CAMPHOR, MENTHOLIvy-Dry, Inc.4792a667-2378-4b3d-968d-9efb1866792f2017-12-27WarningsExact identifier
unii: L7T10EIP3A
Pain ReliefDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCHKareway Product, Inc.d3ede306-9ef7-4a89-896b-c083f6e43c852017-12-05WarningsExact identifier
unii: LAV5U5022Y
ICY FREEZEMENTHOLNATURAL ESSENTIALS, INC.41b2e9a0-818d-4188-8c9d-8ff7c0d0519b2017-12-01WarningsExact identifier
unii: L7T10EIP3A
Sugar Free Cherry Cough DropsMENTHOLArmy & Air Force Exchange Service5d7f7e45-7d69-10dc-e053-2991aa0a389c2017-11-08WarningsExact identifier
unii: L7T10EIP3A
Lidocaine Pain Relief PatchLIDOCAINE AND MENTHOL, UNSPECIFIED FORMFoshan Aqua Gel Biotech Co.,Ltd.3fe1a160-6508-62ea-e054-00144ff8d46c2017-11-06WarningsExact identifier
unii: 98PI200987
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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