Dr. Sheffield Hemorrhoid

Product NDC
11527-056
11-digit product format
115270056
Labeler code
11527
Product ID
11527-056_ee381baf-4f18-49ab-8e93-c44e20bd39a0
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide and Pramoxine Hydrochloride
Dosage form
OINTMENT
Route
RECTAL
Labeler
Sheffield Pharmaceuticals, LLC
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-12-21
Marketing end
0000-00-00
Substance
ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
125 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11527-056DDiscontinued by firm2026-11-12
excluded packagepackage11527-05611527-056-41DDiscontinued by firm2026-11-12
excluded packagepackage11527-05611527-056-50DDiscontinued by firm2026-11-12

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 · 36 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 packagepackage11527-056-50d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11527-056-41d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11527-056-50f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11527-056-41f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11527-056-502ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11527-056-412ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11527-056-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11527-056-41a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11527-056-50cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11527-056-41cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11527-056-50cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11527-056-41cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11527-056-50302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11527-056-41302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11527-056-50ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11527-056-41ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11527-056-500efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11527-056-410efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11527-056-50ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11527-056-41ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11527-056-50367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11527-056-41367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11527-056-50557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11527-056-41557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAMOXINE HYDROCHLORIDEACTIVE INGREDIENT88AYB867L5DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
PRAMOXINEACTIVE MOIETY068X84E056DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7DR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
SHARK LIVER OILINACTIVE INGREDIENT4B24275HEUDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDR. SHEFFIELD HEMORRHOID (ZINC OXIDE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [ SHEFFIELD PHARMACEUTICALS, LLC]1