Home NDC 55628-9204 THERASEPTIN
Product NDC 55628-9204
11-digit product format 556289204
Labeler code 55628
Product ID 55628-9204_8dfca997-03ef-4b49-bc2d-1913ee366e86
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, MENTHOL
Dosage form OINTMENT
Route TOPICAL
Labeler Cal Pharma
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-11-29
Marketing end 0000-00-00
Substance ZINC OXIDE; MENTHOL
Active strength 21 g/100mL; g/100mL
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 · 32 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 55628-9204-4 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 55628-9204-4 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 55628-9204-4 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 55628-9204-4 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 55628-9204-4 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 55628-9204-4 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 55628-9204-4 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 55628-9204-4 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 55628-9204-4 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 55628-9204-4 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 55628-9204-4 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 55628-9204-4 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…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 55628-9204-4 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 55628-9204-4 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 55628-9204-4 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 55628-9204-4 I Inactivated by FDA bd6a592717d7…303034d00443…
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 CASTOR OIL INACTIVE INGREDIENT D5340Y2I9G THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 CETOSTEARYL ALCOHOL INACTIVE INGREDIENT 2DMT128M1S THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 CHLOROTHYMOL INACTIVE INGREDIENT LJ25TI0CVT THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 ETHYLHEXYLGLYCERIN INACTIVE INGREDIENT 147D247K3P THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 GLYCERETH-2 COCOATE INACTIVE INGREDIENT JWM00VS7HC THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 GLYCERYL MONOSTEARATE INACTIVE INGREDIENT 230OU9XXE4 THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 HYDROGENATED POLYBUTENE (1300 MW) INACTIVE INGREDIENT 7D1YQ9Y5EZ THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 PEG-100 STEARATE INACTIVE INGREDIENT YD01N1999R THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 PHENOL INACTIVE INGREDIENT 339NCG44TV THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 POLYMETHYLSILSESQUIOXANE (11 MICRONS) INACTIVE INGREDIENT Z570VEV8XK THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 SHEA BUTTER INACTIVE INGREDIENT K49155WL9Y THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 THEOBROMA GRANDIFLORUM SEED BUTTER INACTIVE INGREDIENT I711F13FXM THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 THYMOL INACTIVE INGREDIENT 3J50XA376E THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V THERASEPTIN (ZINC OXIDE, MENTHOL) OINTMENT [CAL PHARMA] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55628-9204-4 55628920404 120 mL in 1 TUBE (55628-9204-4) 120 ml 2012-11-29 0000-00-00 No No Current