Home NDC 49348-802 Sunmark Phenolated Calamine
Product NDC 49348-802
11-digit product format 493480802
Labeler code 49348
Product ID 49348-802_0ce5c95c-a899-9b32-e063-6294a90a86b9
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide and Phenol
Dosage form LOTION
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance ZINC OXIDE; PHENOL
Active strength 160; 10 mg/mL; 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 Sunmark Phenolated Calamine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/mL PHENOL 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 339NCG44TV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991369 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 49348-802-34 Sunmark Phenolated Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-802 SUNMARK PHENOLATED CALAMINE (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [STRATEGIC SOURCING SERVICES LLC] 6 Current NDC, Legacy NDC, 1 package rows 20231220_8e68efc4-4c95-41c0-9fed-32297b1b2edc.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 27 of 70 · 1,384 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NUVALU PETROLEUM COCOA BUTTER WHITE PETROLATUM JC SALES 490af001-c78c-e2d2-e063-6394a90abdb0 2026-01-01 Warnings Exact identifier application number: M016 NUVALU 100 PURE PETROLEUM WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 4946ac1a-f475-fbb1-e063-6394a90a30bc 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 4946d1b7-ae1b-1e73-e063-6394a90a1ed2 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM BABY FRESH SCENT WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 49471d77-303a-8536-e063-6394a90aea51 2026-01-01 Warnings Exact identifier application number: M016 NUVALU PETROLEUM COCOA BUTTER WHITE PETROLATUM Ningbo Liyuan Daily Chemical Products Co., Ltd. 49472319-09d1-7c4f-e063-6294a90a26a7 2026-01-01 Warnings Exact identifier application number: M016 Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance Free COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 1fa6282a-172e-f5c8-e063-6294a90a4fb1 2025-12-31 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla Latte COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 27713ae6-b428-e0d7-e063-6394a90a7a89 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Body OATMEAL Beiersdorf Inc 9895f3c3-b00b-462c-ace0-696d688e2e04 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Flare Up Treatment OATMEAL Beiersdorf Inc a9ea4832-3211-40b2-accf-90ace7b9e279 2025-12-31 Warnings Exact identifier application number: M016 Eczema Relief Cream Body Wash OATMEAL Beiersdorf Inc f12644e5-0ff0-de0e-e053-2995a90a0995 2025-12-31 Warnings Exact identifier application number: M016 XIMONTH Honey Eye Drops GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4727f304-0bc7-2fee-e063-6394a90a0178 2025-12-30 Warnings Exact identifier application number: M016 Kinfield Relief Balm Anti-Itch Remedy KINFIELD RELIEF BALM ANTI-ITCH REMEDY Kinfield, Inc. bf394192-c789-faff-e053-2995a90a52bc 2025-12-30 Warnings Exact identifier application number: M016 911 ALLANTOIN Skinfix, Inc. f28c251e-a91b-4ed4-8224-b47c345f982f 2025-12-29 Warnings Exact identifier application number: M016 EXTRA STRENGTH BODY COLLOIDAL OATMEAL Skinfix, Inc. 32ba5f29-c037-44dd-b5b1-59001ac50753 2025-12-29 Warnings Exact identifier application number: M016 VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE Compania Internacional de Comercio, S.A.P.I de C.V. 39726b59-bd85-4541-80e5-4f2919842dca 2025-12-29 Warnings Exact identifier application number: M016 Creamy Diaper Rash ZINC OXIDE Davion, Inc 0fdfe7d3-e4cd-6bea-e063-6394a90a37f6 2025-12-29 Warnings Exact identifier application number: M016 Medicated Cornstarch Baby Powder ACTIVE CORN STARCH Davion, Inc. e39032d1-c8cd-4a41-af10-126970b8ad38 2025-12-29 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dcf0b2-4f9f-023a-e053-2995a90a183a 2025-12-28 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dca60a-e9bc-4161-e053-2995a90a2bcb 2025-12-28 Warnings Exact identifier application number: M016 Hydrating Healing HYDRATING HEALING OINTMENT Neilmed Pharmaceuticals Inc., 47106abb-4c39-07d9-e063-6394a90a4fae 2025-12-28 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 49348-802-34 49348080234 177 mL in 1 BOTTLE, PLASTIC (49348-802-34) 177 ml 2017-12-12 0000-00-00 No No Current