SEVERE HEMORRHOIDS

Product NDC
60512-6038
11-digit product format
605126038
Labeler code
60512
Product ID
60512-6038_46b1f8f0-8e08-4461-b48e-4af84ea2bdaf
Type
HUMAN OTC DRUG
Nonproprietary name
PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
HOMEOLAB USA INC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2012-07-25
Marketing end
0000-00-00
Substance
PAEONIA OFFICINALIS ROOT; KRAMERIA LAPPACEA ROOT; NITRIC ACID; SULFUR; PODOPHYLLUM; RUTA GRAVEOLENS FLOWERING TOP; GRAPHITE; APIS MELLIFERA; HORSE CHESTNUT; STRYCHNOS NUX-VOMICA SEED
Active strength
8 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct60512-6038DDiscontinued by firm2026-10-05
excluded packagepackage60512-603860512-6038-0DDiscontinued by firm2026-10-05

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60512-6038-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60512-6038-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60512-6038-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60512-6038-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60512-6038-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60512-6038-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60512-6038-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60512-6038-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60512-6038-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60512-6038-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60512-6038-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60512-6038-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage60512-6038-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage60512-6038-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage60512-6038-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage60512-6038-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage60512-6038-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage60512-6038-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage60512-6038-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage60512-6038-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage60512-6038-09bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60512-6038-02025-12-29C16284748780-19d75b9d0-0f8e-f424-e053-dadaa90a57ceDRUG FACTS
60512-6038-02020-01-31C16284748780-19d75b9d0-0f8e-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43ZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
GRAPHITEACTIVE INGREDIENT4QQN74LH4OSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
HORSE CHESTNUTACTIVE INGREDIENT3C18L6RJAZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
KRAMERIA LAPPACEA ROOTACTIVE INGREDIENTP29ZH1A35ZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
NITRIC ACIDACTIVE INGREDIENT411VRN1TV4SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
PAEONIA OFFICINALIS ROOTACTIVE INGREDIENT8R564U2E1PSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
PODOPHYLLUMACTIVE INGREDIENT2S713A4VP3SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH13919SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
SULFURACTIVE INGREDIENT70FD1KFU70SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
APIS MELLIFERAACTIVE MOIETY7S82P3R43ZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
GRAPHITEACTIVE MOIETY4QQN74LH4OSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
HORSE CHESTNUTACTIVE MOIETY3C18L6RJAZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
KRAMERIA LAPPACEA ROOTACTIVE MOIETYP29ZH1A35ZSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
NITRIC ACIDACTIVE MOIETY411VRN1TV4SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
PAEONIA OFFICINALIS ROOTACTIVE MOIETY8R564U2E1PSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
PODOPHYLLUMACTIVE MOIETY2S713A4VP3SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH13919SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
SULFURACTIVE MOIETY70FD1KFU70SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GSEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60512-6038SEVERE HEMORRHOIDS REAL RELIEF (PAEONIA OFFICINALIS, RATANHIA, NITRICUM ACIDUM, SULFUR, PODOPHYLLUM PELTATUM, RUTA GRAVEOLENS, GRAPHITES, APIS MELLIFICA, AESCULUS HIPPOCASTANUM, NUX VOMICA) TABLET, CHEWABLE [HOMEOLAB USA INC]3Legacy NDC20130117_dd23f58b-1ca5-4c24-8ee9-8a9be4443a2a.zip