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 56 of 68 · 1,358 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.1c5eb3b3-79b3-472a-ae36-ec6a7dc729252024-02-07WarningsExact identifier
unii: V13007Z41A
AntisepticALCOHOL, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.71aeaf86-2b4d-4945-9606-a9db0ab6b7262024-02-07WarningsExact identifier
unii: V13007Z41A
First Aid and BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDESafetec of America, Inc.47cb6921-5d82-4123-a9e0-0b05d4dcb5b22024-02-07WarningsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESafetec of America, Inc.8eb3e7e2-26e5-430e-89aa-40a0367c637e2024-02-07WarningsExact identifier
unii: V13007Z41A
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst8c63be55-5de4-7f72-e053-2995a90a102e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999dd95d-87fe-12c0-e053-2995a90aa9f72024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4bf5905-add7-1cb0-e053-2995a90a73342024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4c0df51-cc37-323d-e053-2995a90a154a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals7a664a34-19fd-4a7b-ab4d-11299b32999e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticalsfd6343a9-15a6-4894-b51f-122e4d6dbe792024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESeton Pharmaceuticals1c0abe84-5404-404e-b882-e910e4d43ffb2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals951862db-3a73-4d25-9d5b-e4111833f43b2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals6aa284d6-0212-4fb5-809d-c721aa6fe2ba2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst993bc59e-5e71-bd9e-e053-2a95a90af85c2024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirstc4c16714-6b1f-857e-e053-2a95a90a74e42024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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