Home NDC 56104-251 Calamine Plus Pramoxine HCl
Product NDC 56104-251
11-digit product format 561040251
Labeler code 56104
Product ID 56104-251_4229a38a-85a1-4153-e063-6294a90a7971
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Premier Brands of America, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-12-20
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
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 .345 mg/116g ZINC OXIDE 24.16 mg/116g PRAMOXINE HYDROCHLORIDE 2.72 mg/116g
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 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 56104-251-00 Calamine Plus Pramoxine HCl 116 g in 1 CANISTER AEROSOL, SPRAY 116 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56104-251 CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20250116_d3452573-f91f-f157-e053-2a95a90a1ad8.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 90 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CHINESE RED TIGER LIDOCAINE PATCHES 4% LIDOCAINE, 1%MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36b9a7a2-5832-4ce5-e063-6294a90aed12 2025-06-12 Warnings Exact identifier application number: M017 PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 375bc794-3289-e610-e063-6294a90a4f9b 2025-06-12 Warnings Exact identifier application number: M017 Methyl Salicylate 10% Pain Relieving METHYL SALICYLATE PureTek Corporation 376493eb-5142-db6d-e063-6294a90a1e73 2025-06-12 Warnings Exact identifier application number: M017 Free and Pure Cold Therapy Pain Relief MENTHOL Walgreen Co. 22cbbffc-f876-411e-e063-6394a90a1b38 2025-06-12 Warnings Exact identifier application number: M017 Methylten 25% Pain Relieving METHYL SALICYLATE PureTek Corporation 3767b97e-ab0c-ac26-e063-6394a90a00cf 2025-06-12 Warnings Exact identifier application number: M017 SPF 50 Mineral Sunscreen ZINC OXIDE Inspec Solutions, LLC 36af9a0a-536b-ee1a-e063-6394a90aace4 2025-06-11 Warnings Exact identifier application number: M017 PLANTAR FASCIITIS Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 37570149-dae1-a4f2-e063-6294a90a3245 2025-06-11 Warnings Exact identifier application number: M017 Diabecin CS Cream MENTHOL, CAPSAICIN Puretek Corporation 33ef2233-7a66-ee65-e063-6294a90ac55a 2025-06-10 Warnings Exact identifier application number: M017 KINKAN COOL DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL KINKANDO CO., LTD . 82011efe-825c-4102-b6f1-59eff4c8040a 2025-06-10 Warnings Exact identifier application number: M017 MQUPIN Knee Patch KNEE PATCH Zhengzhou Miaoqi Medical Technology Co., Ltd. 37438a70-dab7-ecb5-e063-6394a90afefb 2025-06-10 Warnings Exact identifier application number: M017 ORTHOGEL Menthol 3.5% Roll On MENTHOL LiquidCapsule Manufacturing LLC 99424327-67e9-43b5-a117-94c9643413c1 2025-06-07 Warnings Exact identifier application number: M017 Lightning Pain Relief MENTHOL Ebanel Laboratories, Inc 36edbc3f-501c-c1ea-e063-6394a90af6af 2025-06-06 Warnings Exact identifier application number: M017 FREEZE IT Menthol Roll On MENTHOL LiquidCapsule Manufacturing LLC 33094afe-db9d-4b92-8047-6dd611484fc9 2025-06-05 Warnings Exact identifier application number: M017 Band Aid Antiseptic Cleansing BENZALKONIUM CHLORIDE, PRAMOXINE HCL Kenvue Brands LLC d55e6b09-0587-61a9-e053-2995a90afaf5 2025-06-05 Warnings Exact identifier application number: M017 FREEZE IT Menthol MENTHOL LiquidCapsule Manufacturing LLC de8d8007-5718-4fb4-a8c6-4650d2ca9c8f 2025-06-05 Warnings Exact identifier application number: M017 HEEL PAIN Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 36bacb5f-c1af-2e97-e063-6394a90afe5c 2025-06-04 Warnings Exact identifier application number: M017 Capsaicin 0.075% Cream CAPSAICIN ViolaCare, Inc. 30911225-a6d7-4b2b-9005-b733373e2877 2025-06-04 Warnings Exact identifier application number: M017 LidoGuard LIDOCAINE HCL ViolaCare, Inc. 531383aa-4f0f-4fe0-91f4-d809b39f160f 2025-06-04 Warnings Exact identifier application number: M017 HealthWise Lidocaine and Menthol LIDOCAINE AND MENTHOL Veridian Healthcare 36c27642-f913-1aad-e063-6294a90a4343 2025-06-04 Warnings Exact identifier application number: M017 HealthWise Ultra OTC Strength Pain Relief Cream CAMPHOR, MENTHOL, AND METHYL SALICYLATE Veridian Healthcare 36c3bbf9-a559-4c0d-e063-6394a90a8a1a 2025-06-04 Warnings Exact identifier application number: M017
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56104-251-00 56104025100 116 g in 1 CANISTER (56104-251-00) 116 g 2021-12-20 0000-00-00 No No Current