Home NDC 87541-435 Calamine
Product NDC 87541-435
11-digit product format 875410435
Labeler code 87541
Product ID 87541-435_5738485c-72ea-c5b3-e063-6294a90ae81e
Type HUMAN OTC DRUG
Nonproprietary name Calamine and Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Marie's Original Formulas LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-21
Substance ZINC OXIDE; FERRIC OXIDE RED
Active strength 80; 80 mg/mL; mg/mL
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 ZINC OXIDE 80 mg/mL FERRIC OXIDE RED 80 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 1K09F3G675 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.
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 28 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87541-435-45 87541043545 177 mL in 1 BOTTLE, PLASTIC (87541-435-45) 177 ml 2026-07-21 No No Current