Home NDC 0395-0420 Humco Calagesic
Product NDC 0395-0420
11-digit product format 003950420
Labeler code 0395
Product ID 0395-0420_101d12b5-fd3a-678d-e063-6294a90a64ea
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Pramoxine Hydrochloride
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; PRAMOXINE HYDROCHLORIDE
Active strength 80; 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 Humco Calagesic
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 80 mg/mL PRAMOXINE HYDROCHLORIDE 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 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup 1234539 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 0395-0420-96 Humco Calagesic 177 mL in 1 BOTTLE, PLASTIC LOTION 177 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0420 HUMCO CALAGESIC (CALAMINE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231216_8c43590d-56ec-4588-8076-99ba94a16685.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 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 Warnings Exact identifier application number: M016 TENA PROSKIN BARRIER DIMETHICONE Essity HMS North America Inc 118bf2df-ee7b-454f-9c0b-2697dc826268 2025-12-21 Warnings Exact identifier application number: M016 Geri Care Medicated Pads WITCH HAZEL Geri-Care Pharmaceuticals, Corp 2d020e79-2bcf-ba8f-e063-6394a90a6fda 2025-12-19 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 0395-0420-96 00395042096 177 mL in 1 BOTTLE, PLASTIC (0395-0420-96) 177 ml 2017-11-13 0000-00-00 No No Current