Home NDC 82645-420 Freskaro Calamine Plus
Product NDC 82645-420
11-digit product format 826450420
Labeler code 82645
Product ID 82645-420_4f85c89b-114c-d84d-e063-6294a90aa32a
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide lotion
Dosage form LOTION
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-15
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 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 Freskaro Calamine Plus
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 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 82645-420-96 Freskaro Calamine Plus 177 mL in 1 BOTTLE, PLASTIC LOTION 177 1
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 29 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aquaphor Original PETROLATUM Beiersdorf Inc d38ec874-7b8c-4b9b-92b6-286278bb67f3 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Healing Diaper Rash ZINC OXIDE Beiersdorf Inc dec07dfc-67a2-46ad-8fab-828488bdba15 2025-12-15 Warnings Exact identifier application number: M016 HealthWise Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 7ba0ac53-c78c-4a70-a977-a082f731919e 2025-12-15 Warnings Exact identifier application number: M016 Aquaphor Lip Protectant and Sunscreen PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE Beiersdorf Inc a43c2802-9cf1-477e-9f93-e11cf40b480d 2025-12-15 Warnings Exact identifier application number: M016 Prequel Barrier Therapy Rich Skin Protectant Cream SKIN PROTECTANT CREAM The Center Brands, LLC 39945806-8f29-020b-e063-6294a90a9fc6 2025-12-13 Warnings Exact identifier application number: M016 ECZEMA COLLOIDAL OATMEAL Smith Amish, LLC 20c4bc16-ba20-47ec-e063-6394a90a8b4e 2025-12-12 Warnings Exact identifier application number: M016 Humco Calagesic CALAMINE AND PRAMOXINE HYDROCHLORIDE Humco Holding Group, Inc. 8c43590d-56ec-4588-8076-99ba94a16685 2025-12-11 Warnings Exact identifier application number: M016 Soteri Skin Baby Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d88ff2-22aa-8447-e063-6294a90aea0e 2025-12-10 Warnings Exact identifier application number: M016 Soteri Skin Active Flare-Up Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc. 41b558d9-55ba-97ff-e063-6394a90a963b 2025-12-10 Warnings Exact identifier application number: M016 CeraVe Developed With Dermatologist Baby Eczema Relief Cream OATMEAL L'Oreal USA Products Inc 5d392529-9f0c-40bc-92ca-7003f8e64b1c 2025-12-09 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Eczema Relief Moisturizing COLLOIDAL OATMEAL L'Oreal USA Products Inc c4dde987-fe4e-4f8e-8f3a-1bc12c9588ed 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 446ddb19-4bdb-6827-e063-6394a90a6af8 2025-12-09 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm Vanilla COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 45864832-51bb-4e24-e063-6294a90ab554 2025-12-09 Warnings Exact identifier application number: M016 AquaSoothe AQUASOOTHE Dynarex Corporation 45878c3c-d05d-984c-e063-6294a90a4661 2025-12-09 Warnings Exact identifier application number: M016 Soteri Skin Long-Term Eczema Relief Cream COLLOIDAL OATMEAL Soteri Skin, Inc 41d752cb-3866-e840-e063-6394a90acc37 2025-12-09 Warnings Exact identifier application number: M016 Earths Care Eczema OATMEAL DLC Laboratories, Inc. f72e2adf-8930-458f-a6cc-9b240b2f5eba 2025-12-08 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 4575ba40-009c-26e0-e063-6394a90adee6 2025-12-08 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Chai Cinnamon COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 4576cd28-9531-4db4-e063-6394a90a9fd3 2025-12-08 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company beb22d69-8a83-65dc-e053-2a95a90ad812 2025-12-08 Warnings Exact identifier application number: M016 Medicated Hemorrhoidal Pads WITCH HAZEL Cardinal Health 0b49db40-7abc-4e62-b6da-4b9f5b0ae16d 2025-12-05 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 Sample Exclude flag Status 82645-420-96 82645042096 177 mL in 1 BOTTLE, PLASTIC (82645-420-96) 177 ml 2026-04-15 No No Current