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 42 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Witch Hazel WITCH HAZEL TOP CARE (Topco Associates LLC) 23b592f7-3af3-45ef-897a-fe33ab518b6d 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL Strategic Sourcing Services LLC ef3408db-de98-4a43-9215-f80fed14815c 2025-04-14 Warnings Exact identifier application number: M016 Petroleum Jelly PETROLATUM Walgreens 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 2025-04-11 Warnings Exact identifier application number: M016 4% 10gTATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 322daa32-a74e-1fee-e063-6294a90a37aa 2025-04-07 Warnings Exact identifier application number: M016 Aluroderm Scar ALLANTOIN Asclemed USA, Inc. 60656ca1-5218-4595-854e-19f1061def1e 2025-04-01 Warnings Exact identifier application number: M016 Dr. Maxs Diaper ZINC OXIDE Dr. Maxs LLC 31bfa962-5e3b-c5d2-e063-6294a90ac177 2025-04-01 Warnings Exact identifier application number: M016 Vaseline BABY HEALING JELLY Conopco Inc. d/b/a Unilever bca3176f-86fe-5969-e053-2995a90a2419 2025-03-31 Warnings Exact identifier application number: M016 4% TATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 31646815-f591-c560-e063-6294a90ad11a 2025-03-28 Warnings Exact identifier application number: M016 Face Saver Gel SKIN PROTECTANT GEL Neat Feat Products Limited 31563dd7-9f58-80f6-e063-6294a90a5571 2025-03-27 Warnings Exact identifier application number: M016 Porphose COLLOIDAL OATMEAL TOPICAL SPRAY Porphose 315951e0-899f-c968-e063-6294a90abe61 2025-03-27 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fc9eecd-fd25-827c-e063-6394a90a26a5 2025-03-26 Warnings Exact identifier application number: M016 Cocoa Butter Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fcc9626-6058-e9b3-e063-6394a90ab525 2025-03-26 Warnings Exact identifier application number: M016 Nicotine Patches NICOTINE PATCHES Zhejiang FTA Shengzuozhi Biotechnology Co., LTD 313b08e2-d764-96da-e063-6294a90ab705 2025-03-25 Warnings Exact identifier application number: M016 Eczema Cream ECZEMA CREAM Kyte Baby LLC 30c943aa-d9dc-5c16-e063-6294a90a3c58 2025-03-20 Warnings Exact identifier application number: M016 Koala Kubs Diaper Rash Cream DIAPER RASH CREAM Melaleuca, Inc. c6b3b0dd-22a8-16f7-e053-2a95a90a51ea 2025-03-20 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Chattem, Inc. 2b6b8342-878d-4588-8b24-6746d35d319d 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b20bd5-3b4f-8cc7-e063-6394a90a9106 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b2744d-fb59-f383-e063-6294a90abd2a 2025-03-19 Warnings Exact identifier application number: M016 Dr. Butler Hemorrhoid and Perineal MINERAL OIL 59.8%,PETROLATUM 36% Beyond Health P.A. d17b6f16-6893-ce0a-e053-2a95a90aa23a 2025-03-19 Warnings Exact identifier application number: M016 Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream DIMETHICONE, WHITE PETROLATUM Chattem, Inc. b951d1cb-b81e-4d7f-9a67-8405daa89667 2025-03-19 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