Home NDC 64092-413-96 Health Care Calamine
Product NDC 64092-413
Requested package NDC 64092-413-96
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 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 Health Care Calamine
Listing expiration 2027-12-31 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 24 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eczema Reliegf Skin Protectant EQB COLLOIDAL OATMEAL 2% Walmart 37132a0d-37c5-4b21-9673-5f853b3a6248 2026-01-20 Warnings Exact identifier application number: M016 Skin Relief Cream HYDROCORTISONE Spa de Soleil 0a90b77a-4be4-71c5-e063-6294a90a8e41 2026-01-20 Warnings Exact identifier application number: M016 Cold Sore Bandage COLD SORE BANDAGE Shenzhen Hengdasheng Technology Co., Ltd 47f588a2-a69b-cffe-e063-6294a90a0ed4 2026-01-17 Warnings Exact identifier application number: M016 Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 48793a50-89a7-dba9-e063-6394a90a7056 2026-01-16 Warnings Exact identifier application number: M016 HAND SANITIZER HAND SANITIZER Guangdong bangze medicine co., ltd 40018618-8f95-f6db-e063-6394a90ac7dd 2026-01-16 Warnings Exact identifier application number: M016 Lemon Glycerin GLYCERIN Jianerkang Medical Co., Ltd edee14da-13d8-4bc2-9c37-cfc353763d11 2026-01-16 Warnings Exact identifier application number: M016 WORKMANS FRIEND SUPERIOR BARRIER SKIN DIMETHICONE SolvChem, Inc. da12ac2c-1af9-47b1-aa5f-77acb48535ba 2026-01-16 Warnings Exact identifier application number: M016 Walgreens Vitamin A and D skin protectant LANOLIN, PETROLATUM Walgreen Company 9aa6c7f2-0923-4d51-8b9b-63f9a724937a 2026-01-15 Warnings Exact identifier application number: M016 INCONTINENCE CARE WIPE DIMETHICONE Cardinal Health 200, Inc. 1ac34c94-9e3b-45f2-ba19-a07dcd3941dd 2026-01-15 Warnings Exact identifier application number: M016 Alcohol Hand Sanitizer ALCOHOL HAND SANITIZER Guangdong bangze medicine co., ltd 2e8b5afe-6ff8-3e9b-e063-6394a90ad703 2026-01-14 Warnings Exact identifier application number: M016 Alcohol Sanitizer ALCOHOL SANITIZER SPRAY Guangdong bangze medicine co., ltd 2e9db49b-35ce-00d5-e063-6294a90acf35 2026-01-14 Warnings Exact identifier application number: M016 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
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