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 119 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone HYDROCORTISONE Kroger Company fc1677f2-4078-4ebd-9c3b-86a29a35b489 2024-11-12 Warnings Exact identifier application number: M017 CVS Health Lidocaine Cream LIDOCAINE CVS Health ad950680-c03c-4fa5-aa7f-239a889cd097 2024-11-12 Warnings Exact identifier application number: M017 CVS Arthritis Pain Relief ARTHRITIS PAIN RELIEF CVS Health 575dd514-fd99-4e44-8fc8-52938f9abc26 2024-11-11 Warnings Exact identifier application number: M017 ThermaPatch (TM) Lidocaine Pain Relief Patch LIDOCAINE PAIN RELIEF PATCH Henan Enokon Medical Instrument Co., Ltd. 26769590-cd50-1b01-e063-6394a90a445c 2024-11-09 Warnings Exact identifier application number: M017 DG Health Cold Zone Pain Relieving Topical Analgesic MENTHOL, UNSPECIFIED FORM Dolgencorp Inc 22594ab8-9a4a-426f-aced-5c636620fa2c 2024-11-08 Warnings Exact identifier application number: M017 Peviderm Pramoxine Hydrocholride 1% PRAMOXINE HYDROCHLORIDE Stratus Pharmaceuticals Inc 680b40fa-1922-443a-a4b0-7c3f6a2b847d 2024-11-07 Warnings Exact identifier application number: M017 Meijer Analgesic with Aloe Topical Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc f6c1e09e-4c61-4c2a-87d7-b052ed36fcac 2024-11-07 Warnings Exact identifier application number: M017 Meijer Pain Relieving Balm Analgesic TROLAMINE SALICYLATE Meijer Distribution, Inc 1b7535cc-01ac-49f0-9889-dd14b254d4ae 2024-11-07 Warnings Exact identifier application number: M017 BENGAY Tropical Jasmine LIDOCAINE Kenvue Brands LLC c416320a-c0d7-401e-b0fa-44114d76a557 2024-11-06 Warnings Exact identifier application number: M017 Bengay Ultra Strength Large Size MENTHOL, UNSPECIFIED FORM Kenvue Brands LLC f57ccc33-400b-4401-a348-c54d1eb9f5d0 2024-11-06 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing To Go BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d5749cba-32f3-cf9c-e053-2a95a90a4416 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 26473383-282c-fb10-e063-6394a90a5fa2 2024-11-06 Warnings Exact identifier application number: M017 Pain Relieving Cream CAMPHOR AND MENTHOL GOLDEN TIGER DISTRIBUTION L.L.C. 1b6f929a-db65-8a02-e063-6394a90a8b59 2024-11-06 Warnings Exact identifier application number: M017 Meijer Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc bd6f04f9-a23b-45f6-bce2-1ef7203198e1 2024-11-06 Warnings Exact identifier application number: M017 Meijer Cold and Hot Pain Relieving Analgesic LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM Meijer Distribution, Inc 6d356563-9098-4994-8ad8-819a8033a9f4 2024-11-06 Warnings Exact identifier application number: M017 TopCare Maximum Strength Pain Relieving Analgesic MENTHOL, UNSPECIFIED FORM Topco Associates LLC dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab 2024-11-05 Warnings Exact identifier application number: M017 Aveeno Restorative Skin Therapy Itch Relief Balm PRAMOXINE HYDROCHLORIDE Kenvue Brands LLC 61824ca7-a2d3-4830-b2bb-149a3222bfc8 2024-11-05 Warnings Exact identifier application number: M017 Aveeno Hydrocortisone ANTI-ITCH HYDROCORTISONE Kenvue Brands LLC 233de4d7-e533-40cd-a5ed-e8b09abc626e 2024-11-05 Warnings Exact identifier application number: M017 STING MASTER LIDOCAINE HYDROCHLORIDE Les Technologies Ptero, Inc 94c6fd1f-9e74-420b-9d25-61b37953b838 2024-11-05 Warnings Exact identifier application number: M017 Alocane Emergency Burn LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 0c8e65a6-dff3-43b4-a3f1-95deb574ea89 2024-11-05 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