Home NDC 49348-011 Sunmark Calamine
Product NDC 49348-011
11-digit product format 493480011
Labeler code 49348
Product ID 49348-011_0ce55ce7-d70e-5b31-e063-6294a90a7ab7
Type HUMAN OTC DRUG
Nonproprietary name Calamine 8% and Zinc Oxide 8%
Dosage form LOTION
Route TOPICAL
Labeler Strategic Sourcing Services LLC
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 Sunmark 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 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 49348-011-34 Sunmark Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-011 SUNMARK CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [STRATEGIC SOURCING SERVICES LLC] 7 Current NDC, Legacy NDC, 1 package rows 20231220_c7467f21-56cc-43ca-abfa-e62d35c8baa6.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 37 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join THE ZOEUN SKIN TOTAL CARE COLLOIDAL OATMEAL, STURGEON EXTRACT Sturgeonbio Co.,Ltd. 42712685-64d4-0170-e063-6394a90a75d7 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Total Cleanser COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 4275eecd-67bb-fb1c-e063-6294a90aa09a 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Mist Toner COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42766f41-74bc-d19d-e063-6294a90aba53 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Y-Zone Feminine Moisturizer COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42773426-f39f-bebe-e063-6394a90a73d9 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Eye Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42792a80-555b-e86c-e063-6294a90a2f30 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Night Mask COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42843691-8761-3f32-e063-6394a90a59bc 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Nourishing Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42849f5c-a983-c3ce-e063-6394a90a2fb5 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Body Wash COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 4285320a-bf0b-915d-e063-6394a90a9cfd 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Gel COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 42859de3-15dd-c7b9-e063-6394a90af501 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Sturgeon Hair Essence COLLOIDAL OATMAEL Sturgeonbio Co.,Ltd. 4285eb13-d1a2-0663-e063-6294a90ac40f 2025-10-01 Warnings Exact identifier application number: M016 The Zoeun Skin Total Care Cream COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 428643c3-e932-4db5-e063-6294a90ac36c 2025-10-01 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE Geri-Gentle Corporation f5cfab62-8aab-4109-b15b-4fe380f7cb9e 2025-09-29 Warnings Exact identifier application number: M016 GoodSense Petroleum Jelly WHITE PETROLATUM GOOD SENSE 3492f044-250e-45f7-8638-e3c55713e0f5 2025-09-29 Warnings Exact identifier application number: M016 Aveeno Baby Eczema Therapy Moisturizing OATMEAL Kenvue Brands LLC 2a028465-1dff-4ae7-abf6-7521c2784dd1 2025-09-26 Warnings Exact identifier application number: M016 Johnsons Baby First Touch Gift Set ZINC OXIDE Kenvue Brands LLC 3f838eb7-42a3-c96b-e063-6294a90a7491 2025-09-26 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Original WHITE PETROLATUM Veridian Healthcare 1fb96a6c-7d13-4ccf-8fa6-55ec79e6877c 2025-09-25 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Baby Fresh WHITE PETROLATUM Veridian Healthcare 0d3e6c1a-3ba9-4442-bae0-27312d658d07 2025-09-25 Warnings Exact identifier application number: M016 HealthWise Petroleum Jelly Cocoa Butter WHITE PETROLATUM Veridian Healthcare 5c7d9eb6-c129-4fd9-9671-2e0f0453fd28 2025-09-25 Warnings Exact identifier application number: M016 SKIN TAG REMOVER SALICYLIC ACID Shengnan (Guangzhou) Cosmetics Co., LTD 3ee79d66-e728-48dd-e063-6394a90a6463 2025-09-16 Warnings Exact identifier application number: M016 ProCure LanaCare LANOLIN 50% Twin Med LLC 3aabd4ea-107c-a02c-e063-6294a90aee07 2025-09-15 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49348-011-34 49348001134 177 mL in 1 BOTTLE, PLASTIC (49348-011-34) 177 ml 2017-12-12 0000-00-00 No No Current