Home NDC 36800-336 Calamine
Product NDC 36800-336
11-digit product format 368000336
Labeler code 36800
Product ID 36800-336_e1dd126c-f712-4c47-b62a-c5a2b67d9819
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxind HCl
Dosage form LOTION
Route TOPICAL
Labeler Topco associates LLC
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-05-21
Marketing end 0000-00-00
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 9 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-336-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-336-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 36800-336-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 36800-336-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 36800-336-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 36800-336-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 36800-336-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 36800-336-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 36800-336-30 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 zinc oxide ACTIVE INGREDIENT SOI2LOH54Z CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 zinc oxide ACTIVE MOIETY SOI2LOH54Z CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 ROSEMARY OIL INACTIVE INGREDIENT 8LGU7VM393 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [TOPCO ASSOCIATES LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-336-30 36800033630 177 mL in 1 BOTTLE, PLASTIC (36800-336-30) 177 ml 2009-05-21 0000-00-00 No No Current