Home NDC 81522-959 Calamine Plus Pramoxine HCl
Product NDC 81522-959
11-digit product format 815220959
Labeler code 81522
Product ID 81522-959_3cd1933c-6340-50d6-e063-6294a90aca32
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler FSA Store Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-12
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength 5; 75; 10 mg/g; mg/g; mg/g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 Pramoxine HCl
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 5 mg/g ZINC OXIDE 75 mg/g PRAMOXINE HYDROCHLORIDE 10 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 SOI2LOH54Z Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1544717 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 81522-959-01 Calamine Plus Pramoxine HCl 116 g in 1 CAN AEROSOL, SPRAY 116 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 123 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZYLOTROL PAIN RELIEVING LIDOCAINE HCL, MENTHOL Asclemed USA, Inc. 1553351c-aee8-4c40-9548-35cce246bda9 2024-10-25 Warnings Exact identifier application number: M017 Outgro BENZOCAINE Medtech Products Inc. d6be8a1d-aca7-42b1-86da-881d42ffe8d5 2024-10-25 Warnings Exact identifier application number: M017 Monistat Complete Care Instant Itch Relief HYDROCORTISONE Insight Pharmaceuticals LLC a0f40504-6183-4f32-8d17-6586b3f386a6 2024-10-25 Warnings Exact identifier application number: M017 Boil Ease BENZOCAINE Insight Pharmaceuticals LLC bf108934-5e1a-4059-9dcf-008f52a83fab 2024-10-25 Warnings Exact identifier application number: M017 Dermarest Eczema Medicated HYDROCORTISONE Insight Pharmaceuticals LLC 0292ab62-5088-45fa-a056-70c2fcc19ef7 2024-10-25 Warnings Exact identifier application number: M017 anti itch HYDROCORTISONE Meijer, Inc. 2db7bcab-acb8-48ad-8cd1-842ff7765ed9 2024-10-23 Warnings Exact identifier application number: M017 NATUREANCE MIRACLE MENTHOL EROS GLOBAL CORP ec1a2a1f-a38d-9c59-e053-2a95a90ad268 2024-10-23 Warnings Exact identifier application number: M017 Profoot Plantar Relief Strips CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. 65e142d8-da21-4c55-9faf-b387cb6c2c0e 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Rooftop Consumer Health, Inc. cc011b79-2761-40f7-8142-88f8e30a179a 2024-10-23 Warnings Exact identifier application number: M017 Profoot Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Profoot, Inc. 06f82bde-41a1-35f6-e063-6394a90a6437 2024-10-23 Warnings Exact identifier application number: M017 Deep Cover Bug Bite Relief BENZOCAINE Morrisons Outdoors, LLC 25010dd6-fb48-8ee7-e063-6394a90aee6c 2024-10-21 Warnings Exact identifier application number: M017 Evel Knievels Natural Choice Pain Relief MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 4576656c-4b6e-6965-7665-6c52756c6573 2024-10-21 Warnings Exact identifier application number: M017 berkley and jensen anti itch HYDROCORTISONE BJWC 5cc6e4f6-c62d-4923-9726-9dbc569a3f49 2024-10-19 Warnings Exact identifier application number: M017 DG Health Hydrocortisone Maximum Strength HYDROCORTISONE Dolgencorp Inc 2cc792b8-dce6-4178-bd6d-63ba268b7747 2024-10-19 Warnings Exact identifier application number: M017 Careland Hydrogel Pain Relief Patches LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. e970070c-1c3b-49f0-8298-e6c5ebbf50a0 2024-10-18 Warnings Exact identifier application number: M017 Fruit of the Earth Cool Blue Aloe Mist Continuous LIDOCAINE HYDROCHLORIDE Fruit Of The Earth, Inc. d4caae4c-efba-2453-e053-2995a90a5e5f 2024-10-18 Warnings Exact identifier application number: M017 CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving LIDOCAINE HCL CVS Pharmacy f0f1969d-10e0-76ee-e053-2995a90a7336 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wong To Yick Wood Lock Ointment Ltd 16a21af4-6bc0-4ae1-aa3b-1da84c8286e2 2024-10-17 Warnings Exact identifier application number: M017 Wong To Yick External Analgesic CAMPHOR MENTHOL METHYL SALICYLATE Wicsun Trading Inc 0b4bd444-b3c1-47aa-a7e3-f16c92326124 2024-10-17 Warnings Exact identifier application number: M017 Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL LIDOCAINE Fruit of the Earth, Inc. c7a833bd-7457-73a3-e053-2a95a90ac53f 2024-10-17 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81522-959-01 81522095901 116 g in 1 CAN (81522-959-01) 116 g 2025-08-12 No No Current