Home NDC 83324-053 Calamine
Product NDC 83324-053
11-digit product format 833240053
Labeler code 83324
Product ID 83324-053_4bcf72e3-68ba-8e7d-e063-6294a90a7536
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxine HCl
Dosage form LOTION
Route TOPICAL
Labeler Chain Drug Marketing Association
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-26
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Calamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-053-06 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-053 CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [CDMA] 2 Current NDC, 1 package rows 20250228_6c848b98-f01c-40f2-a9aa-2af76cb370c8.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 66 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Baby Soothe and Protect Cream ALLANTOIN Galderma Laboratories, L.P. 38254e03-3716-4e45-86b7-06430ebadc86 2023-11-22 Warnings Exact identifier application number: M016 Cetaphil Baby Eczema Soothing COLLOIDAL OATMEAL Galderma Laboratories, L.P. d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b 2023-11-22 Warnings Exact identifier application number: M016 EczemaHoneyBodyLotion COLLOIDAL OATMEAL Allure Labs 0a710be0-562e-8368-e063-6294a90a3b1b 2023-11-18 Warnings Exact identifier application number: M016 Zinc Oxide SKIN PROTECTANT BluePoint Laboratories d9b752e6-655a-19a6-e053-2995a90a9a37 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL ORIGINAL PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 47b8c720-ad1e-4ac7-ba73-872e409b38bf 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL LAVENDER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 1ac9ee69-339d-4426-b3bf-13e5386f1a9b 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL COCOA BUTTER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC cf888bf3-6950-43aa-b4be-5a32961b4d96 2023-11-15 Warnings Exact identifier application number: M016 UNIVERSAL BABY FRESH SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC b6e0ddb8-3761-482a-83d0-15d612d142eb 2023-11-15 Warnings Exact identifier application number: M016 DERMA SANTE Anti Eczema Cream OATMEAL Hope Science Inc. 1492a6ad-016c-4307-8286-5c564de9e160 2023-11-11 Warnings Exact identifier application number: M016 M3 NATURALS Eczema Cream OATMEAL M3 Naturals LLC 45e2cdde-58fb-4eea-a54d-f53f9ad0d854 2023-11-11 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 53900588-5c9e-4164-816d-017bdbb0f31b 2023-11-11 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Max Strength ZINC OXIDE Geodis Logistics LLC 1b4fd6cb-f2dc-40a2-b958-e99caec91793 2023-11-10 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Original ZINC OXIDE Geodis Logistics LLC 97587458-4ca0-4de3-9bb9-148346d859c0 2023-11-10 Warnings Exact identifier application number: M016 EltaMD Laser Balm PETROLATUM SKIN PROTECTANT CP Skin Health Group, Inc 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb 2023-11-09 Warnings Exact identifier application number: M016 DiaperDerm Diaper Rash ZINC OXIDE Diaperderm Inc 4e1fce3e-c2b7-42da-9953-1dbb13e2467c 2023-11-06 Warnings Exact identifier application number: M016 Doctors Diaper Rash Cream ZINC OXIDE DOCTOR'S DIAPER RASH CREAM, INC 0988ccb1-7881-4d97-bcbf-d0cf4316e4be 2023-11-06 Warnings Exact identifier application number: M016 DERMOIA Manuka Honey Eczema Cream OATMEAL TREASUREWISE LLC a48e52a3-b681-4489-a1fd-6b09d8bc9c55 2023-11-06 Warnings Exact identifier application number: M016 GL HEALTH Barrier Skin Protectant ZINC OXIDE GL HEALTH, INC. 76cfa330-fea9-48d4-b187-469154765d39 2023-11-06 Warnings Exact identifier application number: M016 Skin-lube PETROLATUM, DIMETHICONE The Hygenic Company, LLC. d1005dec-04f6-3f88-e053-2a95a90ad9cb 2023-11-05 Warnings Exact identifier application number: M016 Dr. Sheffield Anti Itch Cream ANTI ITCH CREAM Sheffield Pharmaceuticals LLC 77f0593e-f694-4c02-9fd9-ad56ff2a920c 2023-10-30 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83324-053-06 83324005306 177 mL in 1 BOTTLE, PLASTIC (83324-053-06) 177 ml 2025-02-26 No No Current