Home NDC 37205-130 LEADER Caldyphen
Product NDC 37205-130
11-digit product format 372050130
Labeler code 37205
Product ID 37205-130_9dcad56d-838c-940c-e053-2995a90a57ec
Type HUMAN OTC DRUG
Nonproprietary name ZINC OXIDE, PRAMOXINE HYDROCHLORIDE
Dosage form LOTION
Route TOPICAL
Labeler Cardinal Health
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-03-15
Marketing end 0000-00-00
Substance ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 8 mg/100mL; mg/100mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 26 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 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 37205-130-30 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 37205-130-30 E Excluded after deficient or non-compliant submission was not corrected 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 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 HYPROMELLOSE 2208 (4000 MPA.S) INACTIVE INGREDIENT 39J80LT57T LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [CARDINAL HEALTH] 1 WATER INACTIVE INGREDIENT 059QF0KO0R LEADER CALDYPHEN (ZINC OXIDE, PRAMOXINE HYDROCHLORIDE) LOTION [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 37205-130-30 37205013030 177 mL in 1 BOTTLE (37205-130-30) 177 ml 2012-03-15 0000-00-00 No No Current