Home NDC 37205-405 LEADER HEMORRHOIDAL
Product NDC 37205-405
11-digit product format 372050405
Labeler code 37205
Product ID 37205-405_ece7db10-e0ae-40e3-a4be-c1f03a9dbb38
Type HUMAN OTC DRUG
Nonproprietary name MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL
Dosage form OINTMENT
Route TOPICAL
Labeler CARDINAL HEALTH
Application part346
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-05-01
Marketing end 0000-00-00
Substance MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL
Active strength 140 mg/g; mg/g; mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 37205-405-16 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 37205-405-16 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 37205-405-16 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 37205-405-16 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 37205-405-16 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 37205-405-16 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 37205-405-16 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 37205-405-16 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 37205-405-16 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 37205-405-16 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 37205-405-16 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 37205-405-16 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 37205-405-16 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 37205-405-16 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 37205-405-16 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 37205-405-16 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 37205-405-16 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 37205-405-16 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 37205-405-16 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 37205-405-16 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 37205-405-16 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product I Inactivated by FDA 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 37205-405-16 I Inactivated by FDA 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MINERAL OIL ACTIVE INGREDIENT T5L8T28FGP LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 PETROLATUM ACTIVE INGREDIENT 4T6H12BN9U LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 SHARK LIVER OIL ACTIVE INGREDIENT 4B24275HEU LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 MINERAL OIL ACTIVE MOIETY T5L8T28FGP LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 PETROLATUM ACTIVE MOIETY 4T6H12BN9U LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 SHARK LIVER OIL ACTIVE MOIETY 4B24275HEU LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 THYME OIL INACTIVE INGREDIENT 2UK410MY6B LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL, SHARK LIVER OIL) OINTMENT [CARDINAL HEALTH] 1