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 45 of 198 · 3,957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsExact identifier
unii: G2M7P15E5P
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
unii: G2M7P15E5P
Swiftalyn Numbing CreamMENTHOL 1%GENUINE INNOVATION LTD4b2ebff2-2f50-e54b-e063-6294a90aaccb2026-02-19WarningsExact identifier
unii: L7T10EIP3A
Equate Cold Therapy Pain RelievingMENTHOLWalmart Inc46a3c9e9-5cd3-4bc4-e063-6394a90a71782026-02-19WarningsExact identifier
unii: L7T10EIP3A
Antiseptic Mouth RinseEUCALYPTOLPerrigo Direct, Inc790843ce-88e2-4060-b61f-925fb30272da2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
unii: FM5526K07A
AntisepticEUCAYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inc50776776-80aa-4098-8cf3-6daa0b305b152026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPerrigo Direct, Inccb4cf304-4f19-40cd-b480-9d89d19096842026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.bbf967e1-3a10-4e04-b7c5-2fcd80cc51742026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEMeijer, Inc.fa8ae34c-7b68-454f-8a3b-0eaa93a340922026-02-19Warnings, Adverse reactionsExact identifier
unii: FM5526K07A
CalprotectMENTHOL, ZINC OXIDEReliable 1 Laboratories LLC09fb2810-0cc1-b2e2-e063-6294a90a45762026-02-19WarningsExact identifier
unii: L7T10EIP3A
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEMeijer, Inc.e11390ec-99a3-4ff1-a3c8-ca909f4f67b52026-02-19Warnings, Adverse reactionsExact identifier
unii: FM5526K07A
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.41b8d113-59e0-41e3-b852-0ec7541cad802026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.ec4907e1-d31c-4360-97d9-dc094a5a08ac2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.2aacfe5c-36c8-4890-b6c0-a9511346761e2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
Aloe Vera GelLIDOCAINE HCL, MENTHOLMeijer, Inc.d0cc06c1-c0d5-42f0-82cd-8b704cbe1f462026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
Tartar controlEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLMeijer, Inc.191f01bb-d580-4e96-89d4-ab736b75c51c2026-02-19Warnings, Adverse reactionsExact identifier
unii: L7T10EIP3A
unii: LAV5U5022Y
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4b1a0e6f-aa68-421c-e063-6294a90a426e2026-02-18WarningsExact identifier
unii: L7T10EIP3A
Veiurkiu External Analgesic CreamLIDOCAINEBLOOMWELL GARDENS LLC40ec5e6f-13dc-de04-e063-6294a90af5d52026-02-18WarningsExact identifier
unii: 98PI200987
External Analgesic Cream with Menthol 5%MENTHOL 5%BLOOMWELL GARDENS LLC402faa27-5305-c73d-e063-6394a90a36f22026-02-18WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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