FDA.reportPublic FDA data

NDC 76348-590-01 - Hemporrhoid

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
76348-590
Requested NDC
76348-590-01
Package NDCs from labels
76348-590-01, 76348-590-02
Manufacturer
Renu Laboratories, Inc.
Effective date
2022-01-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HEMPORRHOID CREAMRenu Laboratories, Inc.2022-01-14HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-590-022024-01-30C16284748780-11030e365-05d4-111a-e063-dadaa90a10e2HEMPORRHOID CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-590-01Hemporrhoid28 g in 1 TUBECREAM284
76348-590-02Hemporrhoid1 in 1 BOXCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-590HEMPORRHOID (LIDOCAINE HCL) CREAM [RENU LABORATORIES, INC.]4Legacy NDC, 2 package rows20220115_b4df1e62-2585-fff7-e053-2a95a90aca06.zip

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 67 of 68 · 1,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidotholLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.6d7adaca-67dd-4a4b-a85c-d1c2a568dee22022-09-09Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Miracle FootCream LavenderUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db520c80-2a2a-5eb1-e053-2995a90a5bb42022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Miracle FootCream LemonUREA, GLYCERIN, ALOE, DISODIUM EDTAAloe Vera Korea Co.,Ltd.db525c63-29fd-2033-e053-2995a90a56b92022-03-28WarningsExact identifier
unii: PDC6A3C0OX
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDENovitium Pharma LLCffb2d794-2c88-48a2-beff-d01b6fcea51f2022-03-25Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
d58ff524-01c9-7574-e053-2995a90a7c52b4df1e62-2585-fff7-e053-2a95a90aca062022-01-14WarningsExact identifier
spl id: d58ff524-01c9-7574-e053-2995a90a7c52
spl set id: b4df1e62-2585-fff7-e053-2a95a90aca06
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEInternational Medication Systems, Limited2c48cfac-81eb-4a81-8590-bc94574dd4c32021-12-14Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Bactine MaxBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDEWellSpring Pharmaceutical Corporation28e8a311-20a4-45a1-8d5d-ca42b101c2752021-02-24WarningsExact identifier
unii: V13007Z41A
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lidocaine hydrochlorideLIDOCAINE HYDROCHLORIDEWestminster Pharmaceuticals, LLC6702589d-6a15-40fe-877a-a9a1a4ad0f7a2020-11-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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