Nupercainal Bio-Active Hemorrhoidal

Product NDC
55741-412
11-digit product format
557410412
Labeler code
55741
Product ID
55741-412_b8b95bde-20f8-4c08-aac9-dc4a8130d673
Type
HUMAN OTC DRUG
Nonproprietary name
Hamamelis Virginiana Root Bark/Stem Bark, Echinacea purpurea, Centella asiatica, and Sambucus Nigra Flowering Top
Dosage form
CREAM
Route
TOPICAL
Labeler
Ducere Pharma
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2014-04-07
Marketing end
0000-00-00
Substance
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; ECHINACEA PURPUREA; CENTELLA ASIATICA; SAMBUCUS NIGRA FLOWERING TOP
Active strength
5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55741-412IInactivated by FDA2026-09-14
excluded packagepackage55741-41255741-412-02IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55741-412-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55741-412-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55741-412-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55741-412-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55741-412-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55741-412-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55741-412-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55741-412-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55741-412-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55741-412-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55741-412-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55741-412-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55741-412-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55741-412-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55741-412-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55741-412-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55741-412-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55741-412-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55741-412-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55741-412-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55741-412-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55741-412-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55741-412-022020-01-31C16284748780-19d75b9d0-4f69-f424-e053-dadaa90a57ceNupercainal ® Bio-Active™ Hemorrhoidal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55741-412-02Nupercainal Bio-Active Hemorrhoidal1 in 1 CARTONCREAM11
55741-412-02Nupercainal Bio-Active Hemorrhoidal56.7 g in 1 TUBECREAM56.71

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Centella asiaticaACTIVE INGREDIENT7M867G6T1UNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Echinacea purpureaACTIVE INGREDIENTQI7G114Y98NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Hamamelis Virginiana Root Bark/Stem BarkACTIVE INGREDIENTT7S323PKJSNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Sambucus Nigra Flowering TopACTIVE INGREDIENTCT03BSA18UNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Centella asiaticaACTIVE MOIETY7M867G6T1UNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Echinacea purpureaACTIVE MOIETYQI7G114Y98NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Hamamelis virginiana root bark/stem barkACTIVE MOIETYT7S323PKJSNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Sambucus nigra flowering topACTIVE MOIETYCT03BSA18UNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
dmdm hydantoinINACTIVE INGREDIENTBYR0546TOWNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
lanolinINACTIVE INGREDIENT7EV65EAW6HNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
mentholINACTIVE INGREDIENTL7T10EIP3ANUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
olive oilINACTIVE INGREDIENT6UYK2W1W1ENUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZENUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
Polyoxyl 40 Hydrogenated Castor OilINACTIVE INGREDIENT7YC686GQ8FNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1
yellow waxINACTIVE INGREDIENT2ZA36H0S2VNUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55741-412NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, ECHINACEA PURPUREA, CENTELLA ASIATICA, AND SAMBUCUS NIGRA FLOWERING TOP) CREAM [DUCERE PHARMA]1Legacy NDC, 2 package rows20140424_c0c0bcde-0078-44b7-b207-03ef8547465e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55741-412-02557410412021 in 1 CARTONHistorical