Home NDC 49781-090 Leader
Product NDC 49781-090
11-digit product format 497810090
Labeler code 49781
Product ID 49781-090_2dcad275-3d50-42a1-a7b4-2fd0d1878039
Type HUMAN OTC DRUG
Nonproprietary name Glycerin, Petrolatum, Phenylephrine Hydrochloride and Pramoxine Hydrochloride
Dosage form CREAM
Route RECTAL
Labeler Cardinal Health
Application part346
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-04-28
Marketing end 0000-00-00
Substance GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength 144 mg/L; mg/L; mg/L; mg/L
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 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 49781-090-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 Glycerin ACTIVE INGREDIENT PDC6A3C0OX LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Petrolatum ACTIVE INGREDIENT 4T6H12BN9U LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Pramoxine Hydrochloride ACTIVE INGREDIENT 88AYB867L5 LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Glycerin ACTIVE MOIETY PDC6A3C0OX LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Petrolatum ACTIVE MOIETY 4T6H12BN9U LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Pramoxine ACTIVE MOIETY 068X84E056 LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 .ALPHA.-Tocopherol Acetate INACTIVE INGREDIENT 9E8X80D2L0 LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Aloe Vera Leaf INACTIVE INGREDIENT ZY81Z83H0X LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Cetostearyl Alcohol INACTIVE INGREDIENT 2DMT128M1S LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Cetyl Alcohol INACTIVE INGREDIENT 936JST6JCN LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Glyceryl Monostearate INACTIVE INGREDIENT 230OU9XXE4 LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Mineral Oil INACTIVE INGREDIENT T5L8T28FGP LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Peg-40 Castor Oil INACTIVE INGREDIENT 4ERD2076EF LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Stearyl Alcohol INACTIVE INGREDIENT 2KR89I4H1Y LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1 Water INACTIVE INGREDIENT 059QF0KO0R LEADER (GLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE AND PRAMOXINE HYDROCHLORIDE) CREAM [CARDINAL HEALTH] 1