Home NDC 79481-0615 Calamine Plus
Product NDC 79481-0615
11-digit product format 794810615
Labeler code 79481
Product ID 79481-0615_42660d75-8443-3e31-e063-6294a90a284d
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Pramoxine HCL
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Meijer Distribution Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-25
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength 5; 10; 79.5 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
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 Plus
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 5 mg/g PRAMOXINE HYDROCHLORIDE 10 mg/g ZINC OXIDE 79.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 88AYB867L5 Internal UNII lookup SOI2LOH54Z Internal UNII 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 79481-0615-1 Calamine Plus 116 g in 1 CANISTER AEROSOL, SPRAY 116 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 79481-0615 CALAMINE PLUS (CALAMINE PLUS PRAMOXINE HCL) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.] 2 Current NDC, 1 package rows 20241016_03c46823-0b1f-4101-e063-6294a90aaf94.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 53 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIMS MAX FREEZE LIDOCAINE HYDROCHLORIDE AND MENTHOL, KOBAYASHI Healthcare International, Inc. e364ff83-4aaf-4897-a7da-06581bc321f2 2025-12-18 Warnings Exact identifier application number: M017 Tiger Balm White Regular Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f406161e-a9c4-47d1-8b21-93b1b7938063 2025-12-17 Warnings Exact identifier application number: M017 Resinol PETROLATUM AND RESORCINOL ResiCal, Inc. 03f57a4a-f94b-4ba6-b709-41cfb6e16261 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Maximum Pain Relief LIDOCAINE Veridian Healthcare afc3c16d-0076-44b2-ae7e-5f36d4d8088e 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Max Lidocaine plus Menthol LIDOCAINE, MENTHOL Veridian Healthcare f39a27da-6799-4fc6-97ca-101eac4a9360 2025-12-17 Warnings Exact identifier application number: M017 HealthWise Original Menthol MENTHOL Veridian Healthcare e4bfb6b0-545e-4fbc-8538-4f41a6be1025 2025-12-17 Warnings Exact identifier application number: M017 Welly Polka First Aid Kit HYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE Dongguan Shenglian Tins Products Co., Ltd. d7c4314c-c4c6-4adf-b384-3ac7a7108319 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Therapy MENTHOL Wise Consumer Products 2410a199-f4a3-da6c-e063-6394a90aaace 2025-12-17 Warnings Exact identifier application number: M017 Lidocaine LIDOCAINE, MENTHOL Vive Health LLC 462d3b24-643e-91da-e063-6394a90a0e1d 2025-12-17 Warnings Exact identifier application number: M017 Theragesic METHYL SALICYLATE Mission Pharmacal Company db6c0c77-0a20-d574-a98f-e6c9998b941f 2025-12-17 Warnings Exact identifier application number: M017 Teevodar Pain Relieving MENTHOL Sod-e Biotech Ltd 205b0fef-4f00-db2e-e063-6294a90a93b8 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Arthritis Pain Relief MENTHOL WISE CONSUMER PRODUCTS CO. 116045df-891b-f370-e063-6294a90abe42 2025-12-17 Warnings Exact identifier application number: M017 Frankincense and Myrrh Intensive Foot Therapy MENTHOL Wise Consumer Products 23e56c6b-0f2b-721f-e063-6394a90a1ed0 2025-12-17 Warnings Exact identifier application number: M017 Tiger Balm Ultra Strength CAMPHOR (SYNTHETIC) AND MENTHOL Haw Par Healthcare Ltd. f0561804-e0f7-495d-9768-9b86a208c51e 2025-12-17 Warnings Exact identifier application number: M017 Kwan Loong METHYL SALICYLATE AND MENTHOL Haw Par Healthcare Ltd. 54bcb26e-786a-403e-9330-11ae9e3c013a 2025-12-17 Warnings Exact identifier application number: M017 Magsoothium Body Cooling Formula MENTHOL Ubu/Elements, Inc. f7fb6ac9-a920-a440-e053-6394a90aaa35 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body Lavender MENTHOL Ubu/Elements, Inc. f9b87fbe-b889-67a1-e053-6394a90acbcd 2025-12-16 Warnings Exact identifier application number: M017 Aquaphor Itch Relief HYDROCORTISONE Beiersdorf Inc b1d0333f-ba60-35d8-e053-2995a90af932 2025-12-16 Warnings Exact identifier application number: M017 Magsoothium CBD Body MENTHOL Ubu/Elements, Inc. 00b2ef34-42d7-523c-e063-6294a90a753d 2025-12-16 Warnings Exact identifier application number: M017 GENTLECARE HAND AND SKIN SANITIZER BENZALKONIUM CHLORIDE PARAGON SOLUTIONS US, INC. 16650277-fa62-485e-9a82-7763d2b50168 2025-12-16 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 79481-0615-1 79481061501 116 g in 1 CANISTER (79481-0615-1) 116 g 2023-08-25 No No Current