Home NDC 37205-278 LEADER ANTI ITCH MAXIMUM STRENGTH
Product NDC 37205-278
11-digit product format 372050278
Labeler code 37205
Product ID 37205-278_601af339-4d49-e38c-e053-2991aa0a9f00
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE
Dosage form CREAM
Route TOPICAL
Labeler CARDINAL HEALTH
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-02-10
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 2 g/100g; g/100g
NDC exclude flag No
Listing certified through 2020-12-31
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 · 36 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 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 37205-278-10 I Inactivated by FDA bd6a592717d7…303034d00443…
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 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 ZINC ACTIVE MOIETY J41CSQ7QDS LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER ANTI ITCH MAXIMUM STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 37205-278-10 37205027810 1 TUBE in 1 CARTON (37205-278-10) > 28 g in 1 TUBE 1 tube 2012-02-10 0000-00-00 No No Current