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 92 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Bliss Republic Lidocaine Numbing Cream LIDOCAINE NUMBING CREAM Sargass Group Limited Liability Company 35415851-beba-5bb4-e063-6294a90a35c0 2025-05-16 Warnings Exact identifier application number: M017 Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 352798e1-1e09-3d47-e063-6394a90ad404 2025-05-15 Warnings Exact identifier application number: M017 Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 35285d62-c660-a056-e063-6294a90aabc8 2025-05-15 Warnings Exact identifier application number: M017 SionBiotext Hydrocortisone HYDROCORTISONE ACETATE 1% Sion Biotext Medical Ltd 35073eae-26fe-2bb5-e063-6294a90ab56a 2025-05-13 Warnings Exact identifier application number: M017 Bliss Republic Lidocaine Numbing Cream LIDOCAINE NUMBING CREAM Sargass Group Limited Liability Company 3508ae14-d9c9-3c85-e063-6294a90a0098 2025-05-13 Warnings Exact identifier application number: M017 SORE NO MORE WARM THERAPY MENTHOL AND CAMPHOR SOMBRA COSMETICS INC. cd86b56e-9b4c-4aca-9740-c8793cb12055 2025-05-12 Warnings Exact identifier application number: M017 SORE NO MORE COOL THERAPY MENTHOL SOMBRA COSMETICS INC. 9aa1f0ac-3baf-4e45-9e3a-c28a99b22909 2025-05-12 Warnings Exact identifier application number: M017 Calm and Correct Serum with Lidocaine LIDOCAINE 3 PERCENT Renu Laboratories, LLC ddcf1c2e-2f67-44d7-e053-2a95a90a812b 2025-05-09 Warnings Exact identifier application number: M017 Mqupin Knee Patch KNEE PATCH Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd 09772e4b-8193-3771-e063-6394a90a9516 2025-05-08 Warnings Exact identifier application number: M017 Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA d57a59fb-c8f2-f73b-e053-2995a90a4cdb 2025-05-08 Warnings Exact identifier application number: M017 Hydrocortisone Cream HYDROCORTISONE Trifecta Pharmaceuticals USA 4c96ec41-841c-322b-e054-00144ff8d46c 2025-05-08 Warnings Exact identifier application number: M017 GNP Extra Strength Anti-Itch Cream DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE Amerisource Bergen 34a66224-ef3c-e36e-e063-6394a90ac99d 2025-05-08 Warnings Exact identifier application number: M017 Good Neighbor Muscle Rub Cream CAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%, Amerisource Bergen 34924bb9-e3e8-70e6-e063-6294a90aaa8c 2025-05-07 Warnings Exact identifier application number: M017 DermaRad Relief Post Radiation Calming LIDOCAINE 3 PERCENT Renu Laboratories, LLC e5d64929-fb9c-7ebc-e053-2995a90a9318 2025-05-07 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL InterMed Laboratories Private Limited 33ee0235-5a6e-0ea1-e063-6394a90a89a5 2025-05-06 Warnings Exact identifier application number: M017 DermaRad Relief LIDOCAINE EMULSION RENU LABORATORIES, LLC d5e11f73-918b-eeac-e053-2995a90a4a83 2025-05-06 Warnings Exact identifier application number: M017 Plantar Fasciitis Pain Relief Gel-Patch LIDOCAINE, MENTHOL Guangzhou Zhupuyou E-commerce Co., Ltd 34838622-b092-afeb-e063-6294a90ae7db 2025-05-06 Warnings Exact identifier application number: M017 Climax Shield Delay BENZOCAINE PRODUCT MAX GROUP INC 9c720cdc-f753-47ce-95ff-3b26e461a0ab 2025-05-05 Warnings Exact identifier application number: M017 PediFix Lidocaine Pain-Relief Patches LIDOCAINE PAIN-RELIEF PATCHES PediFix, Inc 346550b9-d2ba-184e-e063-6394a90a591a 2025-05-05 Warnings Exact identifier application number: M017 Walgreens Stop Itch Gel DIPHENHYDRAMINE HCL Walgreens Co 23586336-8f46-3dcd-e063-6394a90accc9 2025-05-04 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