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 130 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SANTO REMEDIO Alivio Pain Relieving Lavender Scent LIDOCAINE HYDROCHLORIDE, MENTHOL SANTO REMEDIO LLC ab53c7f2-a768-4f36-89d6-e128a1a940c2 2024-08-05 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Hydrocortisone HYDROCORTISONE OINTMENT CVS Health ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3 2024-08-02 Warnings Exact identifier application number: M017 Anti-Itch Vulva Cream 1 Hydrocortisone Acetate HYDROCORTISONE ACETATE The Honey Pot Company LLC 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7 2024-08-01 Warnings Exact identifier application number: M017 Anti Itch Soothing 1 Pramoxine Hydrochloride PRAMOXINE HYDROCHLORIDE The Honey Pot Company LLC 8bfeea34-25d5-4721-a17f-d9f1d0084cc3 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Arthritis Achy Foot and Muscle METHYL SALICYLATE The Avon Company 1f440f60-cfc4-511e-e063-6294a90a87db 2024-08-01 Warnings Exact identifier application number: M017 AVON footworks Maximum Strength Cracked Heel BENZALKONIUM CHLORIDE, LIDOCAINE The Avon Company 1f45752e-4a55-431e-e063-6294a90aa57a 2024-08-01 Warnings Exact identifier application number: M017 Relief MENTHOL La Mend, Inc. 1f92de3a-7180-5884-e063-6294a90aebf5 2024-08-01 Warnings Exact identifier application number: M017 Meijer Medicated Foot Powder MENTHOL Meijer Distribution 07ec6c20-73c4-e5e4-e063-6294a90a7e55 2024-07-29 Warnings Exact identifier application number: M017 Ralli Rapid Pain Relief MENTHOL Troy Manufacturing, Inc. e05ec3b7-e9ab-4eaa-8518-86304336697c 2024-07-29 Warnings Exact identifier application number: M017 Walgreens Roll-On CAPSAISIN 0.1% Walgreens Co 1e65bf31-15c7-5e6a-e063-6394a90ac956 2024-07-29 Warnings Exact identifier application number: M017 Camphotrex CAMPHOR, MENTHOL PureTek Corporation 3b6c6eef-e92d-497d-afe8-82356637c2b8 2024-07-26 Warnings Exact identifier application number: M017 Camphotrol CAMPHOR, MENTHOL PureTek Corporation ccac9f37-a374-4765-e053-2a95a90ad2f7 2024-07-26 Warnings Exact identifier application number: M017 Real Time Pain Relief Foot MENTHOL Real Time Products Inc. 29c8e06d-9b29-44f9-ac21-9160d06475cb 2024-07-24 Warnings Exact identifier application number: M017 Capsaicin 0.075 Percent CAPSAICIN Alexso, Inc 33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd 2024-07-22 Warnings Exact identifier application number: M017 TIDL Pain Relief CRYO Therapy Limited Edition PAIN RELIEF CRYO THERAPY LIMITED EDITION Shenzhen Sam Technology Co., Ltd. 1d966b67-fd9c-eab6-e063-6294a90aa75e 2024-07-19 Warnings Exact identifier application number: M017 Fruit of the Earth Aloe Vera Cool Blue LIDOCAINE HYDROCHLORIDE Fruit of the Earth, Inc. 1d65bc34-2bc2-4f52-a9b3-1cb08324eb79 2024-07-19 Warnings Exact identifier application number: M017 Ultra Balm MENTHOL AND METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. de997baf-aa04-474e-b912-3fc67e720d0b 2024-07-19 Warnings Exact identifier application number: M017 Ling Nam Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. 3f16cce3-366f-41f3-8829-6de4082a8c19 2024-07-19 Warnings Exact identifier application number: M017 Koong Yick Hak Kwai Oil TURPENTINE OIL Ling Nam Medicine Factory (H.K.) Ltd. bc33e185-3b42-98b5-e053-2995a90a6308 2024-07-18 Warnings Exact identifier application number: M017 Koong Yick Hung Fa METHYL SALICYLATE Ling Nam Medicine Factory (H.K.) Ltd. 9c8a121d-6da2-4435-a2d7-a0b71d10740d 2024-07-18 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