Home NDC 85786-703 Calamine
Product NDC 85786-703
11-digit product format 857860703
Labeler code 85786
Product ID 85786-703_4ecd0add-11ca-cf3b-e063-6394a90adff6
Type HUMAN OTC DRUG
Nonproprietary name Calamine 8%, Zinc Oxide 8%
Dosage form LOTION
Route TOPICAL
Labeler Farmacias De Similares TX LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-06
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 80; 80 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 80 mg/mL ZINC OXIDE 80 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617954 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 85786-703-06 Calamine 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 7 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Sosnowskis Magic Healing Multi action CAMPHOR AND COLLOIDAL OATMEAL Herstat (USA) Inc. 38cd8f11-7264-a004-e063-6294a90a3a1b 2026-07-03 Warnings Exact identifier application number: M016 Petroleum Skin Protectant WHITE PETROLATUM Publix Super Markets, Inc. c94b5574-3fd7-48a8-94ef-db5d7184fa10 2026-07-02 Warnings, Adverse reactions Exact identifier application number: M016 Drs. Pharmacy Baby Healing ZINC OXIDE OL PHARMA TECH, LLC Drs PHARMACY 55a6981c-1b32-f448-e063-6294a90ac6d8 2026-07-02 Warnings Exact identifier application number: M016 AVANCE ALOE INCONTINENCE CARE DIMETICONE SMART CHOICE MEDICAL INC. 558d239e-b0cf-c145-e063-6294a90a8a8b 2026-07-01 Warnings Exact identifier application number: M016 DIMETHICONE SKIN PROTECTANT DIMETHICONE VIVE HEALTH LLC 5591a321-4831-1844-e063-6394a90a12d1 2026-07-01 Warnings Exact identifier application number: M016 Drs. Pharmacy healing PETROLATUM OL PHARMA TECH, LLC Drs PHARMACY 55947cd9-ca25-0844-e063-6294a90a381f 2026-07-01 Warnings Exact identifier application number: M016 AVANCE ALOE INCONTINENCE CARE DIMETICONE SMART CHOICE MEDICAL INC. 55833e0f-d184-16a2-e063-6394a90acfd3 2026-06-30 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Summer Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 55664a0f-7d46-f002-e063-6394a90a2dc7 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Frosted Grapefruit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5566bce3-fc49-5ef4-e063-6294a90abc7a 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Skin Protectant Velvet Plum COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5568ada5-3ae6-3366-e063-6294a90a7119 2026-06-29 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Skin Protectant Toasted Coconut COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 55698d88-aae7-c46c-e063-6394a90ad0ac 2026-06-29 Warnings Exact identifier application number: M016 Earth Baby Diaper Rash Cream ZINC OXIDE Earth Baby, Inc 42c5cf9a-0a35-5681-e054-00144ff8d46c 2026-06-28 Warnings Exact identifier application number: M016 ORLASKIN HYDROGEL EYE MASK ALLANTOIN Guangzhou Yapheon Health Industry Co., Ltd. 552d072b-396f-c88a-e063-6294a90aabcd 2026-06-26 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM Medline Industries, LP 3c442890-733d-8175-e063-6294a90a8b1c 2026-06-24 Warnings Exact identifier application number: M016 MOROVAN ESTRIOL HONG KONG UNORDERED TRADING CO., LIMITED 54fa4308-44a4-e9dd-e063-6394a90a0cd7 2026-06-24 Warnings Exact identifier application number: M016 EELHOE Sleep Aid Patch GLYCERIN Shantou Eelhoe Daily Chemical Technology Co., Ltd. 550b0494-ca6d-c897-e063-6394a90a8751 2026-06-24 Warnings Exact identifier application number: M016 Hair Regrowth Liquid GLYCERIN Shantou Woodsleep Biotechnology Co., Ltd. 54e662e7-9c63-ad6b-e063-6294a90a1b8d 2026-06-23 Warnings Exact identifier application number: M016 RoyceDerm Eczema Relief Body Wash COLLOIDAL OATMEAL 2% RoyceDerm LLC 54e74eb4-1b42-a748-e063-6394a90aeb16 2026-06-23 Warnings Exact identifier application number: M016 Comfort Shield Barrier DIMETHICONE Sage Products LLC cc08f571-84ae-4c2f-b09d-a83a8efc39f5 2026-06-23 Warnings Exact identifier application number: M016 CLEAR ANTI ITCH PRAMOXINE HCL, ZINC ACETATE LOTION H E B 54f04056-d805-8c62-e063-6394a90ab740 2026-06-23 Warnings, Adverse reactions 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 85786-703-06 85786070306 177 mL in 1 BOTTLE, PLASTIC (85786-703-06) 177 ml 2026-04-06 No No Current