Home NDC 36800-398 Calamine Plus Pramoxine HCl
Product NDC 36800-398
11-digit product format 368000398
Labeler code 36800
Product ID 36800-398_5c529fcd-903f-5e7d-e063-6394a90a3155
Type HUMAN OTC DRUG
Nonproprietary name Calamine Plus Spray
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler Topco Associates LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-01-01
Substance FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength .345; 24.16; 2.72 mg/116g; mg/116g; mg/116g
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-398-41 Calamine Plus Pramoxine HCl 116 g in 1 CANISTER AEROSOL, SPRAY 116 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-398 CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [TOPCO ASSOCIATES LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241213_af314adb-bd65-4233-b7e1-6cfb819615a3.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 146 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUPER BLUE STUFF Pain Relief Cream MENTHOL BLUE SPRING WELLNESS, L.L.C. 066a2106-2e25-4df6-9a8d-4417ba190205 2023-11-10 Warnings Exact identifier application number: M017 INVIGO FLEX Pain Relief Gel MENTHOL WYNNPHARM INC. 909e1d8c-c517-4d6a-8682-894f042c00f8 2023-11-10 Warnings Exact identifier application number: M017 ARNIMAX Penetrating Pain Relief Gel MENTHOL WYNNPHARM INC. 3a31f805-19c6-4036-a663-ebef9b212007 2023-11-10 Warnings Exact identifier application number: M017 KERA HC HYDROCORTISONE Clinical Therapeutic Solutions ac215c8f-b224-480c-9295-3a34316293ba 2023-11-10 Warnings Exact identifier application number: M017 ALO THERAPEUTIC MASSAGE PAIN RELIEVING MENTHOL, HISTAMINE DIHYDROCHLORIDE Theraplex Solutions da004500-5e48-487b-b96f-520a3094096c 2023-11-10 Warnings Exact identifier application number: M017 Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING MENTHOL, METHYL SALICYLATE Rexall Sundown, LLC 55c55f1c-d2b3-6363-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 NEUROFLEX Topical Pain Relieving Liquid CAMPHOR (SYNTHETIC), MENTHOL Almark Products Inc 6da3aa84-7a01-4041-8792-a4bbf49e6e4e 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR 60-second Pain Relief CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 3b74b542-202f-469e-8025-4372e95e6b01 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f8b8d1-a20b-54b0-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f92e71-fe2e-16f4-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M017 Teeter Renew Muscles Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC b90dc5b9-c31d-4770-a291-98d036ae8723 2023-11-10 Warnings Exact identifier application number: M017 SMOOTH GATOR Foot and Leg Rub CAMPHOR (SYNTHETIC), MENTHOL Smooth Gator LLC 57094238-506b-48c1-8eb9-fe904be80df0 2023-11-10 Warnings Exact identifier application number: M017 SKIN A COOL Hydrocortisone Anti-Itch HYDROCORTISONE Ana-Cool, LLC e3ea7406-e494-4038-9b28-8d0a28b4b834 2023-11-10 Warnings Exact identifier application number: M017 Teeter reNEW MUSCLES Pain Relieving METHYL SALICYLATE, MENTHOL STL International INC ebc777b0-d141-4a62-9366-d14787eaefe0 2023-11-10 Warnings Exact identifier application number: M017 FEELGOOD LAB Natural Pain Cream MENTHOL The Feel Good Lab, LLC 799d464c-aaf1-429a-877b-2a692397bb49 2023-11-10 Warnings Exact identifier application number: M017 HIGHER CONTROL Male Climax Control Lubricating BENZOCAINE Product Max Group Inc 5f5fd127-34c5-403a-aa95-c9874ae79492 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f93076-1f68-58e6-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE CMI Therapy Solutions 40f9622e-27c7-6a5d-e054-00144ff88e88 2023-11-10 Warnings Exact identifier application number: M017 FEEL GOOD LAB Natural Pain Cream MENTHOL THE FEEL GOOD LAB, LLC 774a72b1-b719-4217-846e-7f9921fd1b16 2023-11-10 Warnings Exact identifier application number: M017 BODY ACTION PRODUCTS Climax Control Gel BENZOCAINE PRODUCT MAX GROUP INC 53e746cc-0078-4381-bf0b-9c8f98d66904 2023-11-10 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 Marketing end Sample Exclude flag Status 36800-398-41 36800039841 116 g in 1 CANISTER (36800-398-41) 116 g 2017-01-01 0000-00-00 No No Current