Home NDC 64092-413 Health Care Calamine
Product NDC 64092-413
11-digit product format 640920413
Labeler code 64092
Product ID 64092-413_0cf4d771-f6b1-ec8c-e063-6394a90a3551
Type HUMAN OTC DRUG
Nonproprietary name Calamine 8% and Zinc Oxide 8%
Dosage form LOTION
Route TOPICAL
Labeler Great Lakes Wholesale, Marketing and Sales Inc
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2008-01-01
Substance ZINC OXIDE
Active strength 160 mg/mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2026-12-31
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 Health Care Calamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617954 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 64092-413-96 Health Care Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64092-413 HEALTH CARE CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [GREAT LAKES WHOLESALE, MARKETING AND SALES INC] 5 Current NDC, Legacy NDC, 1 package rows 20231221_5d8f02fb-0794-8ec2-e053-2991aa0aac63.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 25 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GG XEROZINE 15 SKIN PROTECTANT GERI-GENTLE CORPORATION e6881c6d-f584-26d0-e053-2995a90a3873 2026-01-14 Warnings Exact identifier application number: M016 Medpura Zinc Oxide 20% MEDPURA ZINC OXIDE 20% Akron Pharma Inc. 3a63aaea-087e-4115-8478-64d416e6085f 2026-01-14 Warnings Exact identifier application number: M016 Walgreens Baby Petroleum PETROLATUM Walgreen Company e79f2bc2-e53b-4d01-9f9b-d9bd5c3b230d 2026-01-14 Warnings Exact identifier application number: M016 Walgreens Cocoa Butter Jelly PETROLEUM Walgreens 32b84286-471a-4d15-80fb-2f516dc1d6ea 2026-01-14 Warnings Exact identifier application number: M016 Hydrating Healing Skin Protectant PETROLATUM OINTMENT CVS Pharmacy c129c2b0-10d5-4b5d-ac5c-2e2512e61279 2026-01-14 Warnings Exact identifier application number: M016 Multi-Purpose Skin Protectant A AND D OINTMENT CVS Pharmacy 60bd0095-25d3-44af-9502-0c63b3d25e66 2026-01-14 Warnings Exact identifier application number: M016 Kenkoderm Eczema Honey Intensive Soothing Balm KENKODERM ECZEMA HONEY INTENSIVE SOOTHING BALM Guangzhou Ariel Biotech Co., Ltd. 48652b9c-4063-cc16-e063-6394a90a3b86 2026-01-14 Warnings Exact identifier application number: M016 Kenkoderm Eczema Honey Soothing Body KENKODERM ECZEMA HONEY SOOTHING BODY LOTION Guangzhou Ariel Biotech Co., Ltd. 4865c697-05fc-eac8-e063-6294a90ae541 2026-01-14 Warnings Exact identifier application number: M016 Gold Bond Medicated eczema relief COLLOIDAL OATMEAL Chattem, Inc. 52744c77-278f-40b1-a356-14ae4366389b 2026-01-14 Warnings Exact identifier application number: M016 Water Drench Hyaluronic Healing Balm DIMETHICONE Peter Thomas Roth Labs, LLC 3f789176-1d80-d146-e063-6294a90a948a 2026-01-13 Warnings Exact identifier application number: M016 DERMEDIAL Anti-Itch OATMEAL, ZINC OXIDE Saje Natural Business Inc 385dd757-740b-8324-e063-6294a90afeee 2026-01-13 Warnings Exact identifier application number: M016 Sweet cheeks ZINC OXIDE Saje Natural Business Inc. 5fc6486e-8604-5c7b-e053-2991aa0a8d14 2026-01-13 Warnings Exact identifier application number: M016 Teevodar ALLANTOIN PEER PHARM LTD. 57a1b6d1-9439-462b-aeb9-ef806e572eaf 2026-01-12 Warnings Exact identifier application number: M016 Botao Baby Diaper Rash Cream ZINC OXIDE Peer Pharm Ltd. df60a70e-e6c0-41b3-e053-2995a90af176 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA HAND RELIEF COLLOIDAL OATMEAL Skinfix, Inc. 0389bab7-04fb-7cfc-e063-6394a90a22d8 2026-01-12 Warnings Exact identifier application number: M016 SKINFIX HAND REPAIR OATMEAL Skinfix, Inc. 1b65fc81-1b9e-4260-829a-332cf6891d02 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA INTENSIVE DAILY RELIEF BODY COLLOIDAL OATMEAL CREAM Skinfix, Inc. 0be3c631-bc9b-00a9-e063-6394a90abcbb 2026-01-12 Warnings Exact identifier application number: M016 Sarna COLLOIDAL OATMEAL Crown Laboratories, Inc. 2d6b1872-9f4d-9eb3-e063-6394a90ab675 2026-01-12 Warnings Exact identifier application number: M016 XIMONTH Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 47f1a711-5d6f-c023-e063-6294a90aa801 2026-01-09 Warnings Exact identifier application number: M016 Endit zinc oxide skin protection ZINC OXIDE EndIt Laboratories, Inc. e60bb0da-3349-f8f9-e053-2a95a90a9051 2026-01-09 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 Marketing end Sample Exclude flag Status 64092-413-96 64092041396 177 mL in 1 BOTTLE, PLASTIC (64092-413-96) 177 ml 2017-10-27 0000-00-00 No No Current