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 49 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trauma Less MENTHOL Natures Formulae Health Products Ltd. 781e94d5-1d34-7202-e053-2991aa0ae768 2025-12-29 Warnings Exact identifier application number: M017 Quality Choice Cold Therapy Gel MENTHOL Chain Drug Marketing Association, Inc. f9c659cd-e7fa-ac2d-e053-6294a90a2573 2025-12-29 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Harris Teeter 5a0501e8-bc06-4e33-8db8-93b21a715141 2025-12-29 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Harris Teeter 9debd4ef-c21b-41ae-afd1-58f47c51c99c 2025-12-29 Warnings Exact identifier application number: M017 Maximum OTC Strength Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) 0e9a711c-ddf4-af63-e063-6294a90a0ebe 2025-12-29 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Harris Teeter 3f5b4eee-49c4-408c-9af2-e7924c26ac63 2025-12-29 Warnings Exact identifier application number: M017 talc-free medicated body MENTHOL Davion, Inc 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b 2025-12-29 Warnings Exact identifier application number: M017 H-E-B Medicated Corn Starch Foot Powder MENTHOL Davion, Inc a6675e00-bc6b-4466-a283-4cece5f91970 2025-12-29 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MENTHOL Davion, Inc 7b442d99-ac19-4f65-828d-954c5350ef5a 2025-12-29 Warnings Exact identifier application number: M017 HEB Medicated Cornstarch Body Powder MENTHOL Davion, Inc df1331fb-48df-4f21-8564-0468078fd12d 2025-12-29 Warnings Exact identifier application number: M017 Honest Med Capsaicin Patch CAPSAICIN Proper Buys LLC 30169d44-b1b2-5c0f-e063-6294a90ae159 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Lavender Roll-on LIDOCAINE HCL Proper Buys LLC 2dcd40a9-3fdd-a71e-e063-6294a90a704f 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Pain Relief Patch LIDOCAINE Proper Buys LLC 13a5243f-7116-e4da-e063-6394a90aa543 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Pain-Relieving Patch MENTHOL, METHYL SALICYLATE, CAMPHOR CVS Pharmacy, Inc. 1f90899c-eeca-2362-e063-6294a90aa0da 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Cooling Patch MENTHOL CVS Pharmacy, Inc 1f90cefe-bcce-5e17-e063-6294a90a5736 2025-12-28 Warnings Exact identifier application number: M017 Point Relief LidoSpot with Menthol LIDOCAINE, MENTHOL Fabrication Enterprises f0c69693-bfea-4006-9620-63b222d25d38 2025-12-28 Warnings Exact identifier application number: M017 DISCOUNT DRUG MART PAIN RELIEF PATCHES LIDOCAINE Discount Drug Mart, Inc e36e7d0a-d554-4601-b535-b41ee84a6b24 2025-12-28 Warnings Exact identifier application number: M017 Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Discount Drug Mart, Inc c01e1a14-bfbc-4c52-8a67-b77acf2d8853 2025-12-28 Warnings Exact identifier application number: M017 TopCare Pain Relief Patch LIDOCAINE, MENTHOL Topco Associates LLC d4c89c4f-d69a-7786-e053-2995a90a71e7 2025-12-28 Warnings Exact identifier application number: M017 Kroger Lidocaine Pain Relieving LIDOCAINE HCL Kroger Company 12d94ba6-56ac-3816-e063-6394a90a44c6 2025-12-28 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