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 26 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Endit Zinc Oxide Skin Protectant ZINC OXIDE Endit Laboratories, Inc. 55b3aa07-871d-421b-b76a-c2d359d6003f 2026-01-09 Warnings Exact identifier application number: M016 Flanders Buttocks WHITE PETROLATUM, ZINC OXIDE Flanders Inc 32371159-c76d-41b0-e054-00144ff88e88 2026-01-09 Warnings Exact identifier application number: M016 Pure Petrolatum Jelly PETROLATUM MY IMPORTS USA LLC 47da77ea-ab4e-fc3c-e063-6394a90a27b7 2026-01-08 Warnings Exact identifier application number: M016 Z-Bum DIAPER RASH CREAM GM Pharmaceuticals, Inc 2a36f396-3a30-3f3f-e054-00144ff8d46c 2026-01-08 Warnings Exact identifier application number: M016 Daily VLotion DIMETHICONE Kindra 1cc4b804-6483-68fd-e063-6294a90a38e4 2026-01-08 Warnings Exact identifier application number: M016 V Relief Serum DIMETHICONE Kindra 1cd8a9e9-ac88-1799-e063-6294a90a3278 2026-01-08 Warnings Exact identifier application number: M016 DR SMITHS DIAPER ZINC OXIDE Mission Pharmacal 7705b182-acf7-4195-9996-7d9fcdfbf055 2026-01-08 Warnings Exact identifier application number: M016 DERMATITIS FACE BALM COLLOIDAL OATMEAL Skinfix, Inc. 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 2026-01-08 Warnings Exact identifier application number: M016 First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power COLLOIDAL OATMEAL JCS Global Distribution, Inc. 47d06283-21cd-4a69-e063-6294a90adb05 2026-01-07 Warnings Exact identifier application number: M016 DE LA CRUZ DIAPER RASH ALLANTOIN, PETROLATUM, AND ZINC OXIDE DLC Laboratories, Inc. 5949aa0f-a7cb-453c-81fd-9fa24653a452 2026-01-07 Warnings Exact identifier application number: M016 Thera Wise Natural Hemorrhoidal WITCH HAZEL Derma Wise Skin Care Ltd. a29fb680-cfc8-4a7b-9970-563fa0e2bed6 2026-01-06 Warnings Exact identifier application number: M016 Sky and Sol SPF25 Lip Balm SKY AND SOL SPF25 LIP BALM Guangzhou Fantesy Biotechnology Co.,Ltd 1f37c0c3-6443-60a3-e063-6394a90a596f 2026-01-05 Warnings Exact identifier application number: M016 Remedy Essentials WHITE PETROLATUM,ZINC OXIDE Medline Industries, LP 42a033d6-782b-2d7f-e054-00144ff8d46c 2026-01-05 Warnings Exact identifier application number: M016 BUNUSS Estriol Face ESTRIOL Jiashen International Trade Limited 478b5690-038a-ba1c-e063-6394a90a3ad6 2026-01-04 Warnings Exact identifier application number: M016 Skin Protectant for Babies and kids SKIN PROTECTANT OINTMENT Neilmed Pharmaceuticals Inc. 448b70db-ca81-db7b-e063-6294a90a5f0d 2026-01-02 Warnings Exact identifier application number: M016 Puriya Eczema Cream COLLOIDAL OATMEAL IPC Republic, Inc. 24ac044e-13fa-5ff6-e063-6294a90a9985 2026-01-01 Warnings Exact identifier application number: M016 Scarzen DIMETHICONE Village Pharma LLC 1550f4e5-22e2-491f-8184-de65da7234e6 2026-01-01 Warnings Exact identifier application number: M016 NUVALU 100 PURE PETROLEUM WHITE PETROLATUM JC SALES 48f74b99-7ead-b0d0-e063-6394a90a4929 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM JC SALES 48f79c2a-b314-169f-e063-6294a90a576e 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM JC SALES 490ac0a6-eac0-a74f-e063-6394a90a84ed 2026-01-01 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