Home NDC 0395-0407 Calamine Phenolated Topical Suspension
Product NDC 0395-0407
11-digit product format 003950407
Labeler code 0395
Product ID 0395-0407_0c92d58b-b1c7-dc2c-e063-6394a90a4d7a
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide and Phenol
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; PHENOL
Active strength 160; 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 Calamine Phenolated Topical Suspension
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 160 mg/mL PHENOL 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 339NCG44TV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 991369 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 0395-0407-96 Calamine Phenolated Topical Suspension 177 mL in 1 BOTTLE, PLASTIC LOTION 177 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PHENOL ACTIVE INGREDIENT 339NCG44TV CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 PHENOL ACTIVE MOIETY 339NCG44TV CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 ZINC CATION ACTIVE MOIETY 13S1S8SF37 CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 BENTONITE INACTIVE INGREDIENT A3N5ZCN45C CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 CALCIUM HYDROXIDE INACTIVE INGREDIENT PF5DZW74VN CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-0407 CALAMINE PHENOLATED TOPICAL SUSPENSION (CALAMINE AND ZINC OXIDE AND PHENOL) LOTION [HUMCO HOLDING GROUP, INC] 6 Current NDC, Legacy NDC, 1 package rows 20231216_a3816729-be2b-4b4f-a609-953576cd2e3b.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 66 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cetaphil Baby Soothe and Protect Cream ALLANTOIN Galderma Laboratories, L.P. 38254e03-3716-4e45-86b7-06430ebadc86 2023-11-22 Warnings Exact identifier application number: M016 Cetaphil Baby Eczema Soothing COLLOIDAL OATMEAL Galderma Laboratories, L.P. d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b 2023-11-22 Warnings Exact identifier application number: M016 EczemaHoneyBodyLotion COLLOIDAL OATMEAL Allure Labs 0a710be0-562e-8368-e063-6294a90a3b1b 2023-11-18 Warnings Exact identifier application number: M016 Zinc Oxide SKIN PROTECTANT BluePoint Laboratories d9b752e6-655a-19a6-e053-2995a90a9a37 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL ORIGINAL PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 47b8c720-ad1e-4ac7-ba73-872e409b38bf 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL LAVENDER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 1ac9ee69-339d-4426-b3bf-13e5386f1a9b 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL COCOA BUTTER SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC cf888bf3-6950-43aa-b4be-5a32961b4d96 2023-11-15 Warnings Exact identifier application number: M016 UNIVERSAL BABY FRESH SCENT PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC b6e0ddb8-3761-482a-83d0-15d612d142eb 2023-11-15 Warnings Exact identifier application number: M016 DERMA SANTE Anti Eczema Cream OATMEAL Hope Science Inc. 1492a6ad-016c-4307-8286-5c564de9e160 2023-11-11 Warnings Exact identifier application number: M016 M3 NATURALS Eczema Cream OATMEAL M3 Naturals LLC 45e2cdde-58fb-4eea-a54d-f53f9ad0d854 2023-11-11 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 53900588-5c9e-4164-816d-017bdbb0f31b 2023-11-11 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Max Strength ZINC OXIDE Geodis Logistics LLC 1b4fd6cb-f2dc-40a2-b958-e99caec91793 2023-11-10 Warnings Exact identifier application number: M016 Boudreauxs Butt Diaper Rash Original ZINC OXIDE Geodis Logistics LLC 97587458-4ca0-4de3-9bb9-148346d859c0 2023-11-10 Warnings Exact identifier application number: M016 EltaMD Laser Balm PETROLATUM SKIN PROTECTANT CP Skin Health Group, Inc 1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb 2023-11-09 Warnings Exact identifier application number: M016 DiaperDerm Diaper Rash ZINC OXIDE Diaperderm Inc 4e1fce3e-c2b7-42da-9953-1dbb13e2467c 2023-11-06 Warnings Exact identifier application number: M016 Doctors Diaper Rash Cream ZINC OXIDE DOCTOR'S DIAPER RASH CREAM, INC 0988ccb1-7881-4d97-bcbf-d0cf4316e4be 2023-11-06 Warnings Exact identifier application number: M016 DERMOIA Manuka Honey Eczema Cream OATMEAL TREASUREWISE LLC a48e52a3-b681-4489-a1fd-6b09d8bc9c55 2023-11-06 Warnings Exact identifier application number: M016 GL HEALTH Barrier Skin Protectant ZINC OXIDE GL HEALTH, INC. 76cfa330-fea9-48d4-b187-469154765d39 2023-11-06 Warnings Exact identifier application number: M016 Skin-lube PETROLATUM, DIMETHICONE The Hygenic Company, LLC. d1005dec-04f6-3f88-e053-2a95a90ad9cb 2023-11-05 Warnings Exact identifier application number: M016 Dr. Sheffield Anti Itch Cream ANTI ITCH CREAM Sheffield Pharmaceuticals LLC 77f0593e-f694-4c02-9fd9-ad56ff2a920c 2023-10-30 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 0395-0407-96 00395040796 177 mL in 1 BOTTLE, PLASTIC (0395-0407-96) 177 ml 2017-11-13 0000-00-00 No No Current