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 36 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join JAFRA Fruteria Coco Fresco Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 9895a320-8a74-4b27-9bf1-4b492f89888c 2025-10-21 Warnings Exact identifier application number: M016 JAFRA Fruteria So Citrico DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. a68d6cda-2268-440a-9ca6-677c4e3ea0e7 2025-10-21 Warnings Exact identifier application number: M016 JAFRA Fruteria Very Verde Lip Balm DIMETHICONE Distribuidora Comercial Jafra, S.A. de C.V. 4f0de70b-7ebe-4381-9b46-d5b334f426e0 2025-10-21 Warnings Exact identifier application number: M016 Gelmicin Hydrocortisone with Aloe HYDROCORTISONE United Exchange Corp. bb64eca4-799d-4711-e053-2995a90af403 2025-10-21 Warnings Exact identifier application number: M016 Quadrydern HYDROCORTISONE Productos Zapotol Corp a087ad4d-9a65-19c3-e053-2995a90ab341 2025-10-21 Warnings Exact identifier application number: M016 VENROCK ROSEMARY OIL Guangzhou Oupeng Cosmetics Co., Ltd 4156b669-1817-6280-e063-6394a90aaf3a 2025-10-17 Warnings Exact identifier application number: M016 Gerigentle-Vitamins A and D PETROLATUM Geri-Gentle Corporation c36c74f7-975b-4e4c-99e3-e6921d782c71 2025-10-17 Warnings Exact identifier application number: M016 Seacall Dexamethasone Ointment. DEXAMETHASONE OINTMENT Guangdong Quadrant Ecological Technology Co., Ltd. 201adf67-773c-34a2-e063-6394a90ac525 2025-10-15 Warnings Exact identifier application number: M016 Medline ZINC OXIDE Medline Industries, LP dae45414-7401-9536-e053-2a95a90a0a86 2025-10-15 Warnings Exact identifier application number: M016 Curology Barrier Balm SKIN BARRIER BALM Curology 04b2ba38-0f81-be51-e063-6294a90af821 2025-10-15 Warnings Exact identifier application number: M016 Petroleum WHITE PETROLATUM Medline Industries, LP 34f3581f-39ba-4f28-9237-52f3820ab4c0 2025-10-09 Warnings Exact identifier application number: M016 Facial Fortress PYRITHIONE ZINC Pediatric Solutions, LLC cdd3c52e-4c32-46c1-bdb3-957b164190bb 2025-10-08 Warnings Exact identifier application number: M016 Happy Cappy PYRITHIONE ZINC Pediatric Solutions, LLC 3d3828d8-ee15-4aff-99d1-a121f0102a00 2025-10-08 Warnings Exact identifier application number: M016 Purforma Advanced Hand Sanitizer 70% Alcohol HAND SANITIZER 70% ALCOHOL Spartan Chemical Company, Inc. 06bd825d-914f-5ca7-e063-6394a90aec49 2025-10-06 Warnings Exact identifier application number: M016 Scar Reducer Intensive Herbal and Nutrient ALLANTOIN Quantum, Inc 5197f1fa-aae5-406c-97d9-635b8c1a88a8 2025-10-06 Warnings Exact identifier application number: M016 PURE SOL SPF 30 LIP BALM CACOA BUTTER ZINC OXIDE Brand 2022b LLC 40537561-d334-5859-e063-6394a90a92a7 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss original ZINC OXIDE Brand 2022b LLC 4056e49a-2976-38f9-e063-6394a90a786d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Nudie rose ZINC OXIDE Brand 2022b LLC 4057b0e2-1c31-abae-e063-6294a90a053d 2025-10-04 Warnings Exact identifier application number: M016 PURE SOL SPF15 Lip Gloss Pink coral ZINC OXIDE Brand 2022b LLC 405865dd-7d0e-048d-e063-6394a90ab105 2025-10-04 Warnings Exact identifier application number: M016 HealthWise Medicated Diabetic Foot Cream DIMETHICONE, PETROLATUM Veridian Healthcare 164f4cd8-975a-40d5-e063-6394a90ae7d5 2025-10-02 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