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 34 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ODLUMIVIE Salmon DNA Repairing Serum RH-OLIGOPEPTIDE-1 ODLUMIVIE 435ecb5b-0d12-4da1-e063-6394a90a8be2 2025-11-11 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM KROGER 3feb1346-76b6-fbb6-e063-6394a90a17d1 2025-11-11 Warnings Exact identifier application number: M016 ODLUMIVIE Ceramide ReviCell Cream CERAMIDE NP ODLUMIVIE 435ee48f-1b9e-6d08-e063-6394a90af5b5 2025-11-11 Warnings Exact identifier application number: M016 ODLUMIVIE Dendrobium Restorative Mask DENDROBIUM OFFICINALE STEM ODLUMIVIE 435ef0e0-50be-c4e4-e063-6294a90a8e8e 2025-11-11 Warnings Exact identifier application number: M016 Au Kah Chuen Fugical CALAMINE AND DIPHENHYDRAMINE HYDROCHLORID Zhejiang Dingtai Pharmaceutical Co., Ltd 5b4add17-6c3d-4093-826a-2edb41c1d1db 2025-11-10 Warnings Exact identifier application number: M016 TATWAX VITAMINS AD PETROLATUM Nantong Health & Beyond Hygienic Products Inc. 333fdce4-5a1d-45a4-94fe-81d47ecd2670 2025-11-07 Warnings Exact identifier application number: M016 Arme Scar Gel DIMETHICONE Nanjing Ludejin Corporation Management Co., Ltd 42e9a59a-480e-f74a-e063-6294a90a0640 2025-11-06 Warnings Exact identifier application number: M016 Baby Diaper Rash Cream ZINC OXIDE Hello Bello 42f14aa6-5694-7727-e063-6294a90a09f3 2025-11-06 Warnings Exact identifier application number: M016 Atti amour Rose Anti-Aging Repair Classic Essence NIACINAMIDE, GLYCERIN RIVER SUNZ co.,Ltd 1e874ac0-a993-be9e-e063-6394a90af424 2025-11-06 Warnings Exact identifier application number: M016 Atti amour Rose Anti-Aging Repair Eye Cream NIACINAMIDE, GLYCERIN RIVER SUNZ co.,Ltd 1eeb9c36-5bd8-ec90-e063-6294a90ae4e1 2025-11-06 Warnings Exact identifier application number: M016 Atti amour Rose Anti-Aging Repair Serum NIACINAMIDE, GLYCERIN RIVER SUNZ co.,Ltd 1eb08f86-eb2a-7f29-e063-6294a90a0516 2025-11-06 Warnings Exact identifier application number: M016 Atti amour Rose Anti-Aging Repair Moisturizing Cream NIACINAMIDE, GLYCERIN RIVER SUNZ co.,Ltd 1eec4cfe-d5a3-3570-e063-6294a90ac38b 2025-11-06 Warnings Exact identifier application number: M016 Spa Dry Heel Foot Relief DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a9 2025-11-05 Warnings Exact identifier application number: M016 Royal Jelly Berry Powerful Lip Care DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 09323fbe-76b5-48c6-80a7-c35b64110a7d 2025-11-05 Warnings Exact identifier application number: M016 Pink Eczema Cream COLLOIDAL OATMEAL MOOGOO SKIN CARE PTY LTD 3b8d92d0-ab7f-8dd5-e063-6394a90aa3af 2025-11-04 Warnings Exact identifier application number: M016 Medline ZINC OXIDE, PETROLATUM Medline Industries, LP f162b1a8-65b3-13a8-e053-2a95a90a3f13 2025-11-04 Warnings Exact identifier application number: M016 Medline PETROLATUM Medline Industries, LP f3062b61-e4c4-9f57-e053-2995a90aa028 2025-11-04 Warnings Exact identifier application number: M016 Sandra Plasencia Dendrobium Officinale Soothing Biofermented Mask TITANIUM DIOXIDE Guangzhou Meijiao Medical Biotechnology Co., Ltd. 3cdf06f2-63f2-7a59-e063-6294a90a72ea 2025-11-03 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL Premier Brands of America Inc. 38583c02-497b-922c-e063-6294a90a49de 2025-11-03 Warnings Exact identifier application number: M016 The Zoeun Omega Serum COLLOIDAL OATMEAL Sturgeonbio Co.,Ltd. 4277da80-b55b-74af-e063-6394a90af325 2025-10-31 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