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 98 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 3a36a241-37a9-445a-a6e0-97709a7457a8 2025-03-19 Warnings Exact identifier application number: M017 Herb Analgesic HERB ANALGESIC PASTE Changsha Maocheng Trading Co., Ltd 29373587-9eff-6ea0-e063-6394a90a23b2 2025-03-18 Warnings Exact identifier application number: M017 DEBACHERE Butt Balm After Play Care Multi Symptoms Relief BENZOCAINE, BENZALKONIUM CHLORIDE DE.BACHERE USA LLC f469b446-58a0-4be3-884f-d622b9d074f8 2025-03-17 Warnings Exact identifier application number: M017 Auvon 4% Menthol Pain Relief Gel MENTHOL SHENZHEN YUWEN E-COMMERCE CO., LTD. 2dacd6fe-7d69-bcf0-e063-6294a90a0351 2025-03-14 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Borden Company (Private) Limited 1ee49cad-84d4-42cf-aa83-c0da6f1b1b84 2025-03-14 Warnings Exact identifier application number: M017 AY BENDITO THERMOACTIVE MENTHOL, CAMPHOR AY BENDITO INTERNATIONAL, INC 304d71b6-91c8-b2b6-e063-6394a90ab669 2025-03-14 Warnings Exact identifier application number: M017 Hot/Cold Medicated Patch HOT COLD PATCH Dynarex 999881b3-287e-d975-e053-2995a90a87e3 2025-03-14 Warnings Exact identifier application number: M017 Capsaicin 0.025% CAPSAICIN 0.025% Marcella Health 3054e7fd-cab2-7f77-e063-6294a90a498d 2025-03-14 Warnings Exact identifier application number: M017 MENTHOL 5% MENTHOL 5% Marcella Health 30914c0a-fbda-5674-e063-6294a90aba5b 2025-03-14 Warnings Exact identifier application number: M017 Peppermint Soothing Patch CAMPHORIC ACID, MENTHOL, UNSPECIFIED FORM Henan Lijitang Medical Technology Co., Ltd. 30361dd4-1f3d-ac5e-e063-6294a90a23bc 2025-03-13 Warnings Exact identifier application number: M017 AVCOO Menthol Pain Relief Patch MENTHOL ADP Health Limited 3036804b-16c3-0c88-e063-6394a90a3084 2025-03-13 Warnings Exact identifier application number: M017 LIDOCAINE 4% LIDOCAINE 4% Marcella Health 303d9462-cbfb-6251-e063-6394a90a7065 2025-03-13 Warnings Exact identifier application number: M017 XeroBurn Burn Gel LIDOCAINE HYDROCHLORIDE Dynarex Corporation 58985046-ca9c-12be-e053-2991aa0abe72 2025-03-13 Warnings Exact identifier application number: M017 Post Treatment Repair Cream HYDROCORTISONE Vege Labs LLC. 302d4327-354b-a252-e063-6394a90a20b6 2025-03-12 Warnings Exact identifier application number: M017 TheraCare Pain Relief 4% Lidocaine LIDOCAINE Veridian Healthcare 2d3fc030-5d53-2acd-e063-6294a90a11ab 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d413707-794c-2fa8-e063-6394a90a06bf 2025-03-11 Warnings Exact identifier application number: M017 Cold Hot Medicated Patch 5% Menthol MENTHOL Veridian Healthcare 2d04799f-946d-ac53-e063-6294a90afeb7 2025-03-11 Warnings Exact identifier application number: M017 Muscle and Joint Care LIDOCAINE Vege Labs LLC. 301966b5-b535-dc04-e063-6394a90aec17 2025-03-11 Warnings Exact identifier application number: M017 Arctic Blast Pain Releiving MENTHOL, CAMPHOR (SYNTHETIC) Nutriomo Labs Pte, Ltd d5e7d26d-4f63-4b7b-a173-fe3a794c8459 2025-03-10 Warnings Exact identifier application number: M017 Anti Itch WALGREEN Walgreens 30014ff0-2519-4031-e063-6394a90ae07b 2025-03-10 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