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 30 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RICHTOFIT RAPID ACTIVE ARTHRITIS MENTHOL AND CAMPHOR RICHTOFIT LIMITED LIABILITY COMPANY 4b1cdab1-3e50-4ec3-e063-6394a90af75e 2026-03-12 Warnings Exact identifier application number: M017 5Kind DMSO 4 Lidocaine HCl Pain Relieving LIDOCAINE HYDROCHLORIDE, MENTHOL 5KIND TRADING LTD 67d8d045-7fa0-46c2-8072-645d8823903b 2026-03-11 Warnings Exact identifier application number: M017 Rapid Relief PAIN RELIEF PATCH LIDOCAINE 4% RAPID AID VIET NAM COMPANY LIMITED 4ca541b4-7afe-77c5-e063-6294a90ad692 2026-03-10 Warnings Exact identifier application number: M017 Lidocaine Cream, 4% LIDOCAINE IPG PHARMACEUTICALS, INC. 7775bfdd-7eac-4f09-b83f-fc4a16a24558 2026-03-10 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR CHEMCO CORPORATION 4c989283-9a27-e8d2-e063-6294a90a8bfa 2026-03-09 Warnings Exact identifier application number: M017 Prequel Anti-Itch Solution Medicated Calming MEDICATED CALMING LOTION The Center Brands, LLC 419fa45b-992b-676e-e063-6394a90add81 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border LIDOCAINE, MENTHOL Planet (Anhui) Pharmaceutical Co., Ltd. 1fda69f7-2bb6-42fc-bcef-677e7b3d7f01 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee MENTHOL, LAUROCAPRAM Planet (Anhui) Pharmaceutical Co., Ltd. 7577625c-87eb-4639-aeab-8a2ab97033fd 2026-03-09 Warnings Exact identifier application number: M017 Careland Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4 2026-03-09 Warnings Exact identifier application number: M017 Rapid Relief PAIN RELIEF PATCH LIDOCAINE 4% RAPID AID VIET NAM COMPANY LIMITED 4ca35030-958c-8f62-e063-6294a90a4d63 2026-03-09 Warnings Exact identifier application number: M017 Welmate Lidocaine Pain Relieving Patch LIDOCAINE YYBA Corp cff71b75-fc4e-29ac-e053-2995a90abd50 2026-03-06 Warnings Exact identifier application number: M017 Heal and Rescue Bunion Pain Relief LIDOCAINE HCL, MENTHOL Rooftop Consumer Health, Inc 4c60d4d3-e0a9-6f93-e063-6394a90a16af 2026-03-06 Warnings Exact identifier application number: M017 JUST CBD - PAIN RELIEF MENTHOL, CAMPHOR Just Brands LLC 4c493c0b-c58e-cb56-e063-6394a90a9395 2026-03-05 Warnings Exact identifier application number: M017 Hug a BooBoo Medicated booboo Wipes BENZOCAINE Lights Medical Manufacture Co., Ltd. 509aaafc-2ef7-4205-818c-7ff5b146e159 2026-03-04 Warnings Exact identifier application number: M017 CVS Foot Pain LIDOCAINE HYDROCHLORIDE CVS Pharmacy 4c3350c3-2e3e-093c-e063-6394a90a3475 2026-03-04 Warnings Exact identifier application number: M017 Game On Sport MENTHOL Natural Essentials, Inc 4c3411dc-5378-bd93-e063-6394a90a8406 2026-03-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Trifecta Pharmaceuticals Usa Llc f4d4a56b-b4b7-9a07-e053-2a95a90ad853 2026-03-04 Warnings Exact identifier application number: M017 Hydrocortisone 1% HYDROCORTISONE Trifecta Pharmaceuticals Usa Llc 9987165c-1a0f-dd57-e053-2a95a90ae735 2026-03-04 Warnings Exact identifier application number: M017 Walgreens Unscented Pain Relieving LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL Walgreen Co. 41eadb4f-2ca5-42a1-e063-6294a90ab4e2 2026-03-04 Warnings Exact identifier application number: M017 Careland Pain Relief Patch Plus LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3 2026-03-04 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