Home NDC 49035-413 Calamine
Product NDC 49035-413
11-digit product format 490350413
Labeler code 49035
Product ID 49035-413_52b88341-bb0b-9bfa-e063-6394a90ad9bf
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Wal-Mart Stores, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-12-30
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 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 49035-413-96 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-413 CALAMINE (CALAMINE AND ZINC OXIDE) LOTION [WAL-MART STORES, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20231220_61929c97-bd6b-0d7c-e053-2991aa0aa571.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 29 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aquaphor Healing Fast Relief Diaper Rash ZINC OXIDE Beiersdorf Inc 887e3566-ec5d-4474-83c6-edcc0732f8d6 2025-12-16 Warnings Exact identifier application number: M016 Aquaphor Healing Balm Stick PETROLATUM Beiersdorf Inc d1670ac6-1672-4b86-e053-2995a90aef60 2025-12-16 Exact identifier application number: M016 Eucerin Eczema Relief Hydrogel OATMEAL Beiersdorf Inc 15c673fa-739e-a14a-e063-6394a90a30de 2025-12-16 Warnings Exact identifier application number: M016 EELHOE Supports Healthy Hearing Drops GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 45f838e3-b643-2fdd-e063-6394a90a62f4 2025-12-15 Warnings Exact identifier application number: M016 Crash Cream WHITE PETROLATUM Claridei Laboratories 01580e8e-93f3-afeb-e063-6294a90a6cbc 2025-12-15 Warnings Exact identifier application number: M016 TrueLipids 1% Hydrocortisone Barrier Cream HYDROCORTISONE Claridei Laboratories 037395dc-5b96-052e-e063-6394a90a26e4 2025-12-15 Warnings Exact identifier application number: M016 TrueLipids Boo-Boo and Bum Balm CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27bf896e-5614-42f3-e063-6394a90ac323 2025-12-15 Warnings Exact identifier application number: M016 TrueLipids Relieve and Protect CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c0af9b-f397-dec3-e063-6394a90aed8b 2025-12-15 Warnings Exact identifier application number: M016 Truelipids TrueLips Lip Balm CL MD WHITE PETROLATUM Claridei Laboratories, Inc. 27c155dc-f194-6750-e063-6394a90a20b1 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing PETROLATUM Beiersdorf Inc 0a17bf6f-6114-4647-a509-65999255c37b 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Original PETROLATUM Beiersdorf Inc d38ec874-7b8c-4b9b-92b6-286278bb67f3 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing Diaper Rash ZINC OXIDE Beiersdorf Inc dec07dfc-67a2-46ad-8fab-828488bdba15 2025-12-15 Warnings Exact identifier application number: M016 HealthWise Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 7ba0ac53-c78c-4a70-a977-a082f731919e 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Lip Protectant and Sunscreen PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Beiersdorf Inc a43c2802-9cf1-477e-9f93-e11cf40b480d 2025-12-15 Warnings Exact identifier application number: M016 Prequel Barrier Therapy Rich Skin Protectant Cream SKIN PROTECTANT CREAM The Center Brands, LLC 39945806-8f29-020b-e063-6294a90a9fc6 2025-12-13 Warnings Exact identifier application number: M016 ECZEMA COLLOIDAL OATMEAL Smith Amish, LLC 20c4bc16-ba20-47ec-e063-6394a90a8b4e 2025-12-12 Warnings Exact identifier application number: M016 Humco Calagesic CALAMINE AND PRAMOXINE HYDROCHLORIDE Humco Holding Group, Inc. 8c43590d-56ec-4588-8076-99ba94a16685 2025-12-11 Warnings Exact identifier application number: M016 Soteri Skin Baby Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d88ff2-22aa-8447-e063-6294a90aea0e 2025-12-10 Warnings Exact identifier application number: M016 Soteri Skin Active Flare-Up Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc. 41b558d9-55ba-97ff-e063-6394a90a963b 2025-12-10 Warnings Exact identifier application number: M016 CeraVe Developed With Dermatologist Baby Eczema Relief Cream OATMEAL L'Oreal USA Products Inc 5d392529-9f0c-40bc-92ca-7003f8e64b1c 2025-12-09 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 49035-413-96 49035041396 177 mL in 1 BOTTLE, PLASTIC (49035-413-96) 177 ml 2017-12-30 0000-00-00 No No Current