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 144 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RUBBING DOTS NATURAL COOL PAIN RELIEF MENTHOL Awesome Trading, LLC 137a88ff-e409-4a67-addc-883194c356ae 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE Lidocaine Hemp Oil Topical Analgesic LIDOCAINE HYDROCHLORIDE Prime Commerce, LLC 28ed2149-38d2-4062-8442-990a98a69cfc 2023-11-11 Warnings Exact identifier application number: M017 MAXOCAINE PAIN RELIEVING ROLL-ON LIDOCAINE HYDROCHLORIDE, MENTHOL Prime Commerce, LLC c263d5f2-89b9-4dfd-91c8-f894e5f956c9 2023-11-11 Warnings Exact identifier application number: M017 SUGAR BRANDS Rescue Pain Relief and Recovery LIDOCAINE HYDROCHLORIDE Sugar Brands, LLC 74013709-d1d5-4425-825d-eee726718c61 2023-11-11 Warnings Exact identifier application number: M017 NATURES CRAFT LIDOCAINE Male Genital Desensitizer LIDOCAINE HYDROCHLORIDE Natures Design Products LLC 61bf1776-5c6c-4307-8348-41fa60164017 2023-11-11 Warnings Exact identifier application number: M017 CLEAN REMEDIES CR PAIN RELIEF MENTHOL Clean Remedies, LLC aea9291d-3244-401c-9607-e91107228faa 2023-11-11 Warnings Exact identifier application number: M017 Arth Arrest METHYL NICOTINATE, CAPSAICIN Key 2 Health, Inc. 495034ac-dbf5-4c55-906b-6ffcbcfd5bc2 2023-11-11 Warnings Exact identifier application number: M017 KINETIC ICE Muscle and Joint Pain Relief Cream MENTHOL No Reason, LLC 565f0e20-e534-41db-ba20-e726d578405f 2023-11-11 Warnings Exact identifier application number: M017 KARMA RUB Elemental Pain Relief LIDOCAINE HYDROCHLORIDE Elemental Bliss LLC c224fb1b-827f-461e-a58f-4020700c3e0d 2023-11-11 Warnings Exact identifier application number: M017 Bakers Best Arthritis Pain Relief with Hemp Seed HISTAMINE DIHYDROCHLORIDE Baker's Best Health Products, LLC 46415d28-99b5-4c9e-bde9-1c703595f671 2023-11-11 Warnings Exact identifier application number: M017 Dr PAINES Pain Relief MENTHOL DOCTOR PAINE'S MEDICAL, LLC 79d2b332-051e-48c1-afe8-6d4468cd1878 2023-11-11 Warnings Exact identifier application number: M017 INTIMALE Maximum Strength Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25b9ade3-72b0-4b86-8c48-90310a26806f 2023-11-11 Warnings Exact identifier application number: M017 POWERECT Max Power Male Delay LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 25a1c926-9543-44a7-865e-a4b6e1a40cbe 2023-11-11 Warnings Exact identifier application number: M017 SKINS DELAY Maximum Strength Lidocaine LIDOCAINE HYDROCHLORIDE SKINS SEXUAL HEALTH LIMITED 172efe5d-28b8-443c-b3f9-429669189081 2023-11-11 Warnings Exact identifier application number: M017 GASPARI Ageless Pain Relief Cream MENTHOL GASPARI ANTI-AGING LLC ea806089-688b-4944-ad69-86f366509eb5 2023-11-11 Warnings Exact identifier application number: M017 ZENSEZONE Arthmed Temporary Pain Relief Cream CAPSAICIN, MENTHOL, METHYL SALICYLATE ZENSEZONE LLC c5778f22-c411-4bd7-b2af-45e3fee15fd2 2023-11-11 Warnings Exact identifier application number: M017 PRFC HEMP Topical Analgesic MENTHOL DOBEST INC 722da9d1-91d7-45be-adb1-8d6a22aa83ac 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 84ea496e-ab54-4882-93ef-600f8eb33cb4 2023-11-11 Warnings Exact identifier application number: M017 AMP RELIEF Pain Relief Cream MENTHOL COASTAL FORMULAS LLC 39564c67-49ab-42d4-a391-792ac69180c0 2023-11-11 Warnings Exact identifier application number: M017 LIDOSOLVE PAIN RELIEF LIDOCAINE HYDROCHLORIDE HENNIKA HEALTH, LLC 3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2 2023-11-11 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