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 51 of 68 · 1,350 matching rows.
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