Home NDC 0395-0400 Humco Calaclear
Product NDC 0395-0400
11-digit product format 003950400
Labeler code 0395
Product ID 0395-0400_0c929258-b193-bc2f-e063-6394a90a8e47
Type HUMAN OTC DRUG
Nonproprietary name Pramoxine Hydrochloride and Zinc Acetate
Dosage form LOTION
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
Substance PRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active strength 10; 1 mg/mL; 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 Calaclear
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PRAMOXINE HYDROCHLORIDE 10 mg/mL ZINC ACETATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 88AYB867L5 Internal UNII lookup FM5526K07A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234546 Internal RxNorm lookup 1248193 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 0395-0400-96 Humco Calaclear 177 mL in 1 BOTTLE, PLASTIC LOTION 177 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PRAMOXINE HYDROCHLORIDE ACTIVE INGREDIENT 88AYB867L5 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PRAMOXINE ACTIVE MOIETY 068X84E056 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 CAMPHOR (NATURAL) INACTIVE INGREDIENT N20HL7Q941 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH HUMCO CALAGESIC (ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [HUMCO HOLDING GROUP, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HUMCO CALAGESIC (ZINC ACETATE 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 0395-0400 HUMCO CALACLEAR (PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE) LOTION [HUMCO HOLDING GROUP, INC.] 7 Current NDC, Legacy NDC, 1 package rows 20231216_5fca3a73-6d66-496b-bd33-6e044f9039bc.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 25 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Water Drench Hyaluronic Healing Balm DIMETHICONE Peter Thomas Roth Labs, LLC 3f789176-1d80-d146-e063-6294a90a948a 2026-01-13 Warnings Exact identifier application number: M016 DERMEDIAL Anti-Itch OATMEAL, ZINC OXIDE Saje Natural Business Inc 385dd757-740b-8324-e063-6294a90afeee 2026-01-13 Warnings Exact identifier application number: M016 Sweet cheeks ZINC OXIDE Saje Natural Business Inc. 5fc6486e-8604-5c7b-e053-2991aa0a8d14 2026-01-13 Warnings Exact identifier application number: M016 Teevodar ALLANTOIN PEER PHARM LTD. 57a1b6d1-9439-462b-aeb9-ef806e572eaf 2026-01-12 Warnings Exact identifier application number: M016 Botao Baby Diaper Rash Cream ZINC OXIDE Peer Pharm Ltd. df60a70e-e6c0-41b3-e053-2995a90af176 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA HAND RELIEF COLLOIDAL OATMEAL Skinfix, Inc. 0389bab7-04fb-7cfc-e063-6394a90a22d8 2026-01-12 Warnings Exact identifier application number: M016 SKINFIX HAND REPAIR OATMEAL Skinfix, Inc. 1b65fc81-1b9e-4260-829a-332cf6891d02 2026-01-12 Warnings Exact identifier application number: M016 ECZEMA INTENSIVE DAILY RELIEF BODY COLLOIDAL OATMEAL CREAM Skinfix, Inc. 0be3c631-bc9b-00a9-e063-6394a90abcbb 2026-01-12 Warnings Exact identifier application number: M016 Sarna COLLOIDAL OATMEAL Crown Laboratories, Inc. 2d6b1872-9f4d-9eb3-e063-6394a90ab675 2026-01-12 Warnings Exact identifier application number: M016 XIMONTH Nail Repairs Patches GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 47f1a711-5d6f-c023-e063-6294a90aa801 2026-01-09 Warnings Exact identifier application number: M016 Endit zinc oxide skin protection ZINC OXIDE EndIt Laboratories, Inc. e60bb0da-3349-f8f9-e053-2a95a90a9051 2026-01-09 Warnings Exact identifier application number: M016 Endit Zinc Oxide Skin Protectant ZINC OXIDE Endit Laboratories, Inc. 55b3aa07-871d-421b-b76a-c2d359d6003f 2026-01-09 Warnings Exact identifier application number: M016 Flanders Buttocks WHITE PETROLATUM, ZINC OXIDE Flanders Inc 32371159-c76d-41b0-e054-00144ff88e88 2026-01-09 Warnings Exact identifier application number: M016 Pure Petrolatum Jelly PETROLATUM MY IMPORTS USA LLC 47da77ea-ab4e-fc3c-e063-6394a90a27b7 2026-01-08 Warnings Exact identifier application number: M016 Z-Bum DIAPER RASH CREAM GM Pharmaceuticals, Inc 2a36f396-3a30-3f3f-e054-00144ff8d46c 2026-01-08 Warnings Exact identifier application number: M016 Daily VLotion DIMETHICONE Kindra 1cc4b804-6483-68fd-e063-6294a90a38e4 2026-01-08 Warnings Exact identifier application number: M016 V Relief Serum DIMETHICONE Kindra 1cd8a9e9-ac88-1799-e063-6294a90a3278 2026-01-08 Warnings Exact identifier application number: M016 DR SMITHS DIAPER ZINC OXIDE Mission Pharmacal 7705b182-acf7-4195-9996-7d9fcdfbf055 2026-01-08 Warnings Exact identifier application number: M016 DERMATITIS FACE BALM COLLOIDAL OATMEAL Skinfix, Inc. 86d2db7d-f1d4-4bca-aba4-d4c96b83c1a6 2026-01-08 Warnings Exact identifier application number: M016 First Aid Beauty Dry Skin Rescue Kit 5x Hydration Power COLLOIDAL OATMEAL JCS Global Distribution, Inc. 47d06283-21cd-4a69-e063-6294a90adb05 2026-01-07 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 0395-0400-96 00395040096 177 mL in 1 BOTTLE, PLASTIC (0395-0400-96) 177 ml 1998-03-25 0000-00-00 No No Current