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 102 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Medicated CAMPHOR MENTHOL METHYL SALICYTATE RITE AID CORPORATION 60895211-69f3-478b-a33f-1c2071f62950 2025-01-16 Warnings Exact identifier application number: M017 Elgin Pain Relief MENTHOL Eco-Logics, Inc. 70eda21e-e566-42f4-9a49-b0d3ad000652 2025-01-16 Warnings Exact identifier application number: M017 Curist Lidocaine Patch Maximum Strength LIDOCAINE Little Pharma, Inc. e574c188-cc65-287d-e053-2995a90a5972 2025-01-16 Warnings Exact identifier application number: M017 Equate Hydrocortisone Topical HYDROCORTISONE WalMart 1f64555d-f77e-4a83-b222-fdb3ed7d8853 2025-01-16 Warnings Exact identifier application number: M017 Equate Hydrocortisone HYDROCORTISONE WalMart f5c32b4a-1159-4b7a-b8ac-256d53020dc2 2025-01-16 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 296fcc36-563f-19ca-e063-6394a90ab3ae 2025-01-15 Warnings Exact identifier application number: M017 K19 RELIEF MENTHOL K19 LLC e2e1ca96-1ae8-4c99-b8de-ce26754292f9 2025-01-15 Warnings Exact identifier application number: M017 Anecream LIDOCAINE 4% Focus Health Group 2d7706e2-7363-4047-96cb-85b718277e8c 2025-01-15 Warnings Exact identifier application number: M017 Boroleum CAMPHOR, MENTHOL, WHITE PETROLATUM Reliable 1 Laboratories 846568af-0fdd-a80e-e053-2a91aa0a9c9e 2025-01-15 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Advanced Rx of Tennessee, LLC 27d5997b-1cc2-41c2-e063-6394a90ac74a 2025-01-15 Warnings Exact identifier application number: M017 Pain Relief Patch 4% Lidocaine LIDOCAINE Reliable 1 Laboratories LLC 2b624763-c310-63d9-e063-6394a90a1928 2025-01-15 Warnings Exact identifier application number: M017 Cannarelief 1000mg MENTHOL Carolina Cannabis Creations LLC 01e2ae1a-c969-6dd2-e063-6394a90a9d9e 2025-01-15 Warnings Exact identifier application number: M017 Healing Hand Cream 2000mg MENTHOL Carolina Cannabis Creations LLC 01f8795b-9f95-c793-e063-6394a90a8330 2025-01-15 Warnings Exact identifier application number: M017 CBD Clinic Deep-Rub Pain Relief - Level 5 CAMPHOR, MENTHOL ABACUS HEALTH PRODUCTS, INC. 31e2e5cd-d33e-f058-e063-6394a90af7d2 2025-01-14 Warnings Exact identifier application number: M017 Meijer Odor Free Analgesic Pain Relieving Topical Analgesic LIDOCAINE HYDROCHLORIDE Meijer Distribution, Inc 6288efea-f636-4eea-bb9f-78aa2f9af54a 2025-01-14 Warnings Exact identifier application number: M017 IKONIK TONIK LIDOCAINE HYDROCHLORIDE IKONIK CARE, LLC 122fdfe8-b5fa-46d1-9fd9-3df9887ed320 2025-01-14 Warnings Exact identifier application number: M017 elp essential MANTECA DE UBRE METHYL SALICYLATE, CAMPHOR Miramar Cosmetics, Inc DBA Miramar Lab c3964dfe-17fe-4d89-a4c4-cf500f982259 2025-01-13 Warnings Exact identifier application number: M017 Methylten METHYL SALICYLATE 10% Puretek Corporation 28f4093f-803f-0e70-e063-6294a90a98a4 2025-01-13 Warnings Exact identifier application number: M017 Refill Bundle 7 Large Office BENZALKONIUM CHLORIDE CMC Group, Inc. 6620a8f3-098d-d045-e053-2a91aa0a0d94 2025-01-13 Warnings Exact identifier application number: M017 Jakwork Numbing Cream NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 2ba1de83-494a-6c54-e063-6294a90a9b2d 2025-01-13 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