Home NDC 41163-536-30 Calamine
Product NDC 41163-536
Requested package NDC 41163-536-30
11-digit product format 411630536
Labeler code 41163
Product ID 41163-536_5aa99c82-3d5d-b0a0-e063-6394a90a1b11
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxine HCl
Dosage form LOTION
Route TOPICAL
Labeler United Natural Foods, Inc. dba UNFI
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-05-21
Substance FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength 80; 10 mg/mL; mg/mL
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FERRIC OXIDE RED 80 mg/mL PRAMOXINE HYDROCHLORIDE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1K09F3G675 Internal UNII lookup 88AYB867L5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1234532 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-536-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-536 CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [UNITED NATURAL FOODS, INC. DBA UNFI] 5 Current NDC, Legacy NDC, 1 package rows 20240925_0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea.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 1 of 68 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pharmacys Prescription 4.5 OZ Creamy Petroleum Jelly WHITE PETROLATUM American Consumer Products Corp. 5c3eb6b1-d570-0b4c-e063-6394a90af462 2026-09-24 Warnings Exact identifier application number: M016 Dermaka Infants and Kids Multi Purpose Skin Protectant ZINC OXIDE Dermaka Skin Products LLC f84dfd55-db6c-4d75-be67-4d13a139e209 2026-09-10 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose DIMETHICONE L'Oreal USA Products Inc 805cd262-2689-4818-8fed-ddefacbdde23 2026-09-10 Warnings Exact identifier application number: M016 La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose DIMETHICONE Cosmetique Active Production d19f482c-bec7-45aa-b22f-fe91a3dc717d 2026-09-10 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE CVS Pharmacy, Inc. 35e67726-4527-4cd7-8e73-30325a32402c 2026-09-09 Warnings, Adverse reactions Exact identifier application number: M016 Lanolin, Petrolatum LANOLIN, PETROLATUM CVS Pharmacy, Inc. 606f65a8-08fd-4ab6-9d68-03ddf662bdf0 2026-09-09 Warnings, Adverse reactions Exact identifier application number: M016 Eczema Soothing Moisturizing Cream COLLOIDAL OATMEAL Nice-Pak Products, LLC 23548524-2e2e-4d1a-9ebb-6f86d6279e93 2026-09-09 Warnings, Adverse reactions Exact identifier application number: M016 Advanced Healing PETROLATUM Walgreen Co. 22bd8e87-965c-466b-bb9b-7d4753e500bc 2026-09-09 Warnings, Adverse reactions Exact identifier application number: M016 Drs. pharmacy Scar Cream ALLANTOIN OL PHARMA TECH, LLC Drs PHARMACY d0381034-8cf7-5e8d-e053-2995a90a9faa 2026-09-09 Warnings Exact identifier application number: M016 Drs. Pharmacy baby healing PETROLATUM OL PHARMA TECH, LLC Drs PHARMACY 5b14ffa0-9486-a7fe-e063-6394a90ab3ed 2026-09-09 Warnings Exact identifier application number: M016 Wart Remover GLYCERIN Shantou Ouhoe Technology Co., Ltd. 5af3afe1-dad5-91b7-e063-6294a90ab95e 2026-09-08 Warnings Exact identifier application number: M016 Medline DIMETHICONE Medline Industries, LP 5afb3595-f014-153e-e063-6294a90ad34b 2026-09-08 Warnings Exact identifier application number: M016 Medline DIMETHICONE Medline Industries, LP 5afb59b4-491c-45bb-e063-6294a90a0ae6 2026-09-08 Warnings Exact identifier application number: M016 Claravie ALUMINUM HYDROXIDE GEL Gentell LLC 5afea757-8feb-f907-e063-6394a90a6259 2026-09-08 Warnings Exact identifier application number: M016 Clear Anti Itch PRAMOXINE HCL, ZINC ACETATE United Natural Foods, Inc. dba UNFI 242adc68-f9e0-4f69-a580-a107d1634b50 2026-09-04 Warnings, Adverse reactions Exact identifier application number: M016 Calamine CALAMINE, PRAMOXINE HCL United Natural Foods, Inc. dba UNFI 0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea 2026-09-04 Warnings, Adverse reactions Exact identifier application number: M016 ndc (package): 41163-536-30 ndc (product): 41163-536 ndc11 (package): 41163053630 FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5a9aaca8-474a-0393-e063-6394a90a5a3a 2026-09-04 Warnings Exact identifier application number: M016 Aveeno Eczema Therapy Cream COLLOIDAL OATMEAL Kenvue Brands LLC 5a7b0470-3ed5-5b92-e063-6294a90ae0f4 2026-09-03 Warnings Exact identifier application number: M016 First Aid Beauty Face and Body Bestsellers Kit COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 5a974dbf-84ac-5374-e063-6294a90a8da0 2026-09-03 Warnings Exact identifier application number: M016 Nail Treatment Liquid GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 5a7cd607-a50e-17d0-e063-6294a90acdb2 2026-09-02 Warnings Exact identifier application number: M016
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 41163-536-30 41163053630 177 mL in 1 BOTTLE, PLASTIC (41163-536-30) 177 ml 2009-05-21 0000-00-00 No No Current