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 19 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Biofreeze Menthol MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC 3f2b1f48-2d78-4985-a046-9f72de5e1a9b 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 10a8face-47da-ebbe-e063-6294a90a42fe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Cream MENTHOL Reckitt Benckiser LLC 32450cbf-4ed4-402b-a30e-e08a17bba3fb 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC a227213b-e89f-7144-e053-2a95a90a7e74 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze MENTHOL Reckitt Benckiser LLC 00bb462a-27d0-6f74-e063-6394a90a90ec 2026-05-13 Warnings Exact identifier application number: M017 BioFreeze Dry Stick MENTHOL Reckitt Benckiser LLC 26d62cd2-9209-8cca-e063-6394a90a2028 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foot Pain Relief Set MENTHOL Reckitt Benckiser LLC 4a885eef-0364-4655-bccc-7158c76cc5b2 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless Roll-On MENTHOL Reckitt Benckiser LLC a8d59d45-0e85-43d1-affd-bbe922c4acb1 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Colorless MENTHOL Reckitt Benckiser LLC 939dbbc3-71ec-4990-840e-7c9b8d430562 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Flexible Relief Strip MENTHOL Reckitt Benckiser LLC 6ec26bae-e395-49aa-969e-8c653d6f0b27 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Day and Overnight MENTHOL Reckitt Benckiser LLC fb5c8f89-a720-ad32-e053-6294a90a2abe 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Foam MENTHOL Reckitt Benckiser LLC 890191e8-99ad-489c-8f21-2592f3d31936 2026-05-13 Warnings Exact identifier application number: M017 Orajel Cold Sore Touch Free - Single Dose BENZALKONIUM CHLORIDE, BENZOCAINE Church & Dwight Co., Inc. ce40829e-941f-2548-e053-2995a90a1e0e 2026-05-13 Warnings Exact identifier application number: M017 Lidocaine Pain Relief Patch LIDOCAINE GERI-CARE PHARMACEUTICAL CORP 51b7753b-8619-6ea9-e063-6294a90a4ea4 2026-05-13 Warnings Exact identifier application number: M017 DERMFREE Anti-itch Cream HYDROCORTISONE1% ANTI-ITCH CREAM Jiangxi Zhongletang Pharmaceuticals Co.,Ltd. 519c319a-9c43-0e63-e063-6394a90ab869 2026-05-13 Warnings Exact identifier application number: M017 Valtrum TOPICAL ANALGESIC CAMPHOR, MENTHOL, METHYL SALICYLATE Laboratorios Quantium LLC f3c4cc3a-f3a3-4d02-97e0-9c3fc1a67c3e 2026-05-13 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless MENTHOL, UNSPECIFIED FORM Reckitt Benckiser 4639201c-a67a-475f-8df6-3dc6225803ad 2026-05-12 Warnings Exact identifier application number: M017 Biofreeze Professional Colorless Roll-On MENTHOL, UNSPECIFIED FORM Reckitt Benckiser LLC bae9946a-4c68-4759-9fb3-0a61a7ad0eb7 2026-05-12 Warnings Exact identifier application number: M017 Instaflex Pain Relief Cream MENTHOL Healthy Directions, LLC 665b847a-9cfb-49fc-975b-81c97f936575 2026-05-12 Warnings Exact identifier application number: M017 Theracare Cold Therapy Pain Relief MENTHOL Veridian Healthcare 51a5a043-07b6-1c96-e063-6394a90aa926 2026-05-12 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