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 49 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bamboobies Diaper Rash ZINC OXIDE 15% Derma Care Research Labs, LLC 0411f5e3-03d2-c512-e063-6394a90a37d3 2024-12-19 Warnings Exact identifier application number: M016 Maximum Strength Medicated Foot Powder MEDICATED FOOT POWDER Jell Pharmaceuticals Pvt. Ltd. cdaae985-5363-e9d2-e053-2995a90a2682 2024-12-18 Warnings Exact identifier application number: M016 BABY FRESH SCENT PETROLEUM WHITE PETROLEUM Jell Pharmaceuticals Pvt Ltd. d80d21cf-9463-7184-e053-2995a90a23f3 2024-12-18 Warnings Exact identifier application number: M016 Health Smart Baby Petroleum WHITE PETROLEUM Home Smart Products edd9d018-c2c9-4a9a-b727-0a92cd463c02 2024-12-18 Warnings Exact identifier application number: M016 Health Smart Cocoa Butter Petroleum WHITE PETROLEUM Home Smart Products a65c8267-d34f-4542-a7ca-5180e860a03d 2024-12-18 Warnings Exact identifier application number: M016 Princess Petroleum WHITE PETROLATUM Ultra Distributors Inc. 6d9c92bf-9263-40a4-acac-5c3f0b08c69d 2024-12-18 Warnings Exact identifier application number: M016 Meijer Petroleum Jelly WHITE PETROLATUM Meijer Distribution, Inc b299cf2a-2c6a-68f4-e053-2995a90a5bd7 2024-12-18 Warnings Exact identifier application number: M016 Foster and Thrive Caldyphen CALAMINE AND PRAMOXINE HYDROCHLORIDE Strategic Sourcing Services, LLC 29945734-4ea6-b702-e063-6294a90ae6f2 2024-12-18 Warnings Exact identifier application number: M016 Foster and Thrive Caldyphen Clear PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE Strategic Sourcing Services, LLC 29946912-9794-8a8e-e063-6394a90a279e 2024-12-18 Warnings Exact identifier application number: M016 Caring Mills Petroleum Jelly WHITE PETROLATUM Veridian Healthcare fbbfa780-0e2b-1874-e053-6394a90a5eeb 2024-12-18 Warnings Exact identifier application number: M016 Serawise Eczema Rescue OATMEAL DrAnaMaria.com LLC e805866a-2349-4b86-bc83-a7c859cb9403 2024-12-18 Warnings Exact identifier application number: M016 TheraCare Petroleum Jelly WHITE PETROLATUM Veridian Healthcare d6fad49b-8a49-7f7c-e053-2a95a90ae638 2024-12-18 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 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