Western Family Hemorrhoidal

Product NDC
55312-035
11-digit product format
553120035
Labeler code
55312
Product ID
55312-035_7823fa33-13ad-492e-842e-af3f5ca88cd9
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Western Family Food, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-30
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
140 mg/100g; mg/100g; mg/100g
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct55312-035IInactivated by FDA2026-10-21
excluded packagepackage55312-03555312-035-57IInactivated by FDA2026-10-21

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 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 packagepackage55312-035-57d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55312-035-57f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55312-035-572ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55312-035-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55312-035-57cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55312-035-57cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55312-035-57302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55312-035-57ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55312-035-570efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55312-035-57ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55312-035-57367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55312-035-57557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage55312-035-578af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage55312-035-57834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage55312-035-571332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55312-035-57fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55312-035-5786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55312-035-57bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage55312-035-578dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage55312-035-57e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage55312-035-579bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage55312-035-57110d247fa046…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
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55312-035-572019-11-27C16284748780-19855d018-d952-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55312-035-57Western Family Hemorrhoidal57 g in 1 TUBEOINTMENT571
55312-035-57Western Family Hemorrhoidal1 in 1 CARTONOINTMENT11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
MINERAL OILACTIVE MOIETYT5L8T28FGPWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9UWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0WESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
LANOLININACTIVE INGREDIENT7EV65EAW6HWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
THYME OILINACTIVE INGREDIENT2UK410MY6BWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FWESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55312-035WESTERN FAMILY HEMORRHOIDAL (MINERAL OIL) OINTMENT [WESTERN FAMILY FOOD, INC.]1Legacy NDC, 2 package rows20130702_9ea5e0ce-2bce-4a27-9701-046913a21b09.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55312-035-575531200355757 g in 1 TUBE57 gHistorical