Home NDC 41163-009-30 Calamine
Product NDC 41163-009
Requested package NDC 41163-009-30
11-digit product format 411630009
Labeler code 41163
Product ID 41163-009_0349fa6e-7153-4648-95f4-159c87c8b16a
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxind HCl
Dosage form LOTION
Route TOPICAL
Labeler Super valu, Inc
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-05-21
Marketing end 0000-00-00
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength 9 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 41163-009 41163-009-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 41163-009 41163-009-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 [SUPER VALU, INC] 1 PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 LAVENDER OIL INACTIVE INGREDIENT ZBP1YXW0H8 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 ROSEMARY OIL INACTIVE INGREDIENT 8LGU7VM393 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [SUPER VALU, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-009 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [UNITED NATURAL FOODS, INC. DBA UNFI] 14 Legacy NDC 20240925_667aa8d3-3dc5-4a80-96e9-6453f6c95e82.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41163-009-30 41163000930 177 mL in 1 BOTTLE, PLASTIC (41163-009-30) 177 ml 2009-05-21 0000-00-00 No No Current