Home NDC 0395-0413 Humco Calamine
Product NDC 0395-0413
11-digit product format 003950413
Labeler code 0395
Product ID 0395-0413_52b9f60d-7ae7-26c8-e063-6294a90acc20
Type HUMAN OTC DRUG
Nonproprietary name Calamine 8% and Zinc Oxide 8%
Dosage form LOTION
Route TOPICAL
Labeler Humco holding Group, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
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 Humco 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-0413-96 Humco Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0413 HUMCO CALAMINE (CALAMINE 8% AND ZINC OXIDE 8%) LOTION [HUMCO HOLDING GROUP, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20231216_f7dcd959-fb98-43bb-8dd3-a662bf8a053c.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 30 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CVS Health Medicated WITCH HAZEL CVS Pharmacy a74ab253-cafc-4f00-9b8f-e5c1e6e7f221 2025-12-05 Warnings Exact identifier application number: M016 Major Medi-Pads WITCH HAZEL Major Pharmaceuticals d2a314a2-98ab-4ac0-9e90-1a8c1303958f 2025-12-05 Warnings Exact identifier application number: M016 Good Sense Medicated WITCH HAZEL Geiss, Destin & Dunn, Inc 5f122db5-4391-4957-9c25-76834c356c4f 2025-12-05 Warnings Exact identifier application number: M016 Witch Hazel MEDICATED HEMORRHOIDAL WIPES Giant Eagle cdd9d6b7-cbc9-2839-e053-2a95a90ada00 2025-12-05 Warnings Exact identifier application number: M016 Cool Comfort ORGANIC WITCH HAZEL Naticura Inc de14c19c-56b5-4727-9194-94e85425ca8a 2025-12-05 Warnings Exact identifier application number: M016 GOODSENSE Maximum Strength Medicated WITCH HAZEL GEISS, DESTIN & DUNN, INC 5453a12b-e775-4101-bd3a-337857e9e167 2025-12-05 Warnings Exact identifier application number: M016 Medicated Multipurpose Wipes WITCH HAZEL QUEST USA CORP. 0f28d5f9-b20a-ac6f-e063-6394a90ac208 2025-12-05 Warnings Exact identifier application number: M016 Gold Bond Medicated eczema relief COLLOIDAL OATMEAL Gold Bond Co LLC c292e443-7418-4679-b9b2-4e6d96c04c4c 2025-12-05 Warnings Exact identifier application number: M016 Prequel Skin Utility Oint MULTI PURPOSE SKIN PROTECTANT The Center Brands, LLC 2bf0931e-245d-14a6-e063-6294a90a6681 2025-12-04 Warnings Exact identifier application number: M016 Prequel Skin Utility Balm Multi-Purpose Skin Protectant SKIN PROTECTANT BALM The Center Brands, LLC 57c0b71d-6099-415c-976d-b96d2f73e9d3 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Gold Bond Co LLC 8fbbfde8-ead1-434f-ae23-6e69662638e1 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Diabetics Dry Skin Relief Foot Cream DIMETHICONE AND WHITE PETROLATUM Gold Bond Co LLC 77b8c30b-d5ba-42ce-9313-4ce1b0bce873 2025-12-04 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Hand Cream COLLOIDAL OATMEAL Gold Bond Co LLC b96e5deb-f2c7-421b-afac-bffb1c9b37ac 2025-12-04 Warnings Exact identifier application number: M016 UNIVERSAL PURE PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 6bc34bbe-e324-48f4-b6df-dd508b19c2e2 2025-12-03 Warnings Exact identifier application number: M016 Calming Itch and Irritation COLLOIDAL OATMEAL Better Planet Brands LLC 1dd7e712-56a4-86c0-e063-6294a90a75cd 2025-12-03 Warnings Exact identifier application number: M016 Pediadermics eczema 3 COLLOIDAL OATMEAL, DIMETHICONE Renu Laboratories, LLC af861f0b-4387-6861-e053-2995a90a8bfa 2025-12-02 Warnings Exact identifier application number: M016 Flexitol Face and Eyelid Eczema OATMEAL LaCorium Health USA Inc. f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65 2025-12-02 Warnings Exact identifier application number: M016 ProCure HydroShield PETROLATUM 41% Twin Med LLC 3d36e664-ac10-72eb-e063-6294a90a49c4 2025-12-01 Warnings Exact identifier application number: M016 ProCure Vitamin A and D WHITE PETROLATUM 93.4% Twin Med LLC 3d385a07-2a12-fce7-e063-6294a90a32d6 2025-12-01 Warnings Exact identifier application number: M016 ESTRIOL ESTRIOL Shenzhen Mengyue Technology Co., Ltd. 44de9eb4-080e-bfbc-e063-6394a90ac0ea 2025-12-01 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 0395-0413-96 00395041396 177 mL in 1 BOTTLE, PLASTIC (0395-0413-96) 177 ml 2017-11-13 0000-00-00 No No Current