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 191 of 197 · 3,939 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: 0N8672707O
LidocaineLIDOCAINEProficient Rx LP2b9150ea-a876-4511-8d5b-aa72507ef8632023-06-01Warnings, Adverse reactionsExact identifier
unii: 98PI200987
good sense clearlaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company9858edef-cdb2-4ac4-8e4b-ba0720a24e412023-06-01WarningsExact identifier
unii: G2M7P15E5P
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsExact identifier
unii: G2M7P15E5P
Theraworx Relief for Foot Cramps FoamMAGNESIUM SULFATE, UNSPECIFIED FORMAVADIM HOLDINGS, INC.2f7fe6b7-deb0-4bf7-a8cb-15ae468512da2023-04-25WarningsExact identifier
unii: DE08037SAB
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ATO TellMENTHOL, GARLIC OILsunkyung tradingf8b5525c-b4bf-d2ee-e053-6394a90a61c52023-04-06WarningsExact identifier
unii: L7T10EIP3A
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: PDC6A3C0OX
lidocaineLIDOCAINEAsclemed USA, Inc.58c9afe4-dc36-4f71-8e76-8dff63dc35fb2023-03-27Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: BKJ0J3D1BP
LidocaineLIDOCAINEBryant Ranch Prepacka134c265-4fb6-4c78-b9cc-fae8f1fff1cf2023-03-15Warnings, Adverse reactionsExact identifier
unii: 98PI200987
LidocaineLIDOCAINEBryant Ranch Prepack68bc320f-2871-45b9-815e-bb26081e82492023-03-02Warnings, Adverse reactionsExact identifier
unii: 98PI200987
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
unii: L7T10EIP3A
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LidocaineLIDOCAINEBryant Ranch Prepackda9707e2-f830-45e2-a300-1f99cf3dd3622023-02-20Warnings, Adverse reactionsExact identifier
unii: 98PI200987
LidocaineLIDOCAINEQUAGEN PHARMACEUTICALS LLCf8789807-cc0c-485c-aa98-1bdc39337deb2023-02-15Warnings, Adverse reactionsExact identifier
unii: 98PI200987

Reported adverse events (FAERS/openFDA)#

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