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 36 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gerigentle-Vitamins A and D PETROLATUM Geri-Gentle Corporation c36c74f7-975b-4e4c-99e3-e6921d782c71 2025-10-17 Warnings Exact identifier application number: M016 Seacall Dexamethasone Ointment. DEXAMETHASONE OINTMENT Guangdong Quadrant Ecological Technology Co., Ltd. 201adf67-773c-34a2-e063-6394a90ac525 2025-10-15 Warnings Exact identifier application number: M016 Medline ZINC OXIDE Medline Industries, LP dae45414-7401-9536-e053-2a95a90a0a86 2025-10-15 Warnings Exact identifier application number: M016 Curology Barrier Balm SKIN BARRIER BALM Curology 04b2ba38-0f81-be51-e063-6294a90af821 2025-10-15 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Medline Industries, LP 34f3581f-39ba-4f28-9237-52f3820ab4c0 2025-10-09 Warnings Exact identifier application number: M016 Facial Fortress PYRITHIONE ZINC Pediatric Solutions, LLC cdd3c52e-4c32-46c1-bdb3-957b164190bb 2025-10-08 Warnings Exact identifier application number: M016 Happy Cappy PYRITHIONE ZINC Pediatric Solutions, LLC 3d3828d8-ee15-4aff-99d1-a121f0102a00 2025-10-08 Warnings Exact identifier application number: M016 Purforma Advanced Hand Sanitizer 70% Alcohol HAND SANITIZER 70% ALCOHOL Spartan Chemical Company, Inc. 06bd825d-914f-5ca7-e063-6394a90aec49 2025-10-06 Warnings Exact identifier application number: M016 Scar Reducer Intensive Herbal and Nutrient ALLANTOIN Quantum, Inc 5197f1fa-aae5-406c-97d9-635b8c1a88a8 2025-10-06 Warnings Exact identifier application number: M016 PURE SOL SPF 30 LIP BALM CACOA BUTTER ZINC OXIDE Brand 2022b LLC 40537561-d334-5859-e063-6394a90a92a7 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss original ZINC OXIDE Brand 2022b LLC 4056e49a-2976-38f9-e063-6394a90a786d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Nudie rose ZINC OXIDE Brand 2022b LLC 4057b0e2-1c31-abae-e063-6294a90a053d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Pink coral ZINC OXIDE Brand 2022b LLC 405865dd-7d0e-048d-e063-6394a90ab105 2025-10-04 Warnings Exact identifier application number: M016 HealthWise Medicated Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 164f4cd8-975a-40d5-e063-6394a90ae7d5 2025-10-02 Warnings Exact identifier application number: M016 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
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