Hemorrhoidal

Product NDC
37808-188
11-digit product format
378080188
Labeler code
37808
Product ID
37808-188_10074833-1586-491f-9d91-295f3128362a
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum, phenylephrine HCl
Dosage form
OINTMENT
Route
RECTAL
Labeler
H E B
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-04-20
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE
Active strength
14 g/100g; g/100g; g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct37808-188DDiscontinued by firm2026-10-20
excluded packagepackage37808-18837808-188-16DDiscontinued by firm2026-10-20

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 · 24 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 packagepackage37808-188-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-188-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage37808-188-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage37808-188-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage37808-188-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage37808-188-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage37808-188-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage37808-188-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage37808-188-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage37808-188-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage37808-188-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage37808-188-16557ba5c1ecfa…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
MINERAL OILACTIVE INGREDIENTT5L8T28FGPHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
MINERAL OILACTIVE MOIETYT5L8T28FGPHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PETROLATUMACTIVE MOIETY4T6H12BN9UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
CORN OILINACTIVE INGREDIENT8470G57WFMHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
LANOLININACTIVE INGREDIENT7EV65EAW6HHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
THYME OILINACTIVE INGREDIENT2UK410MY6BHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FHEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [H E B]1