Home NDC 11344-136 Calamine
Product NDC 11344-136
11-digit product format 113440136
Labeler code 11344
Product ID 11344-136_5c148e64-6bd1-2028-e063-6294a90a2872
Type HUMAN OTC DRUG
Nonproprietary name Calamine, Pramoxind HCl
Dosage form LOTION
Route TOPICAL
Labeler Nice-Pak Products, LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-09-08
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
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-136-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-136 CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [CONSUMER PRODUCT PARTNERS, LLC] 1 Current NDC, 1 package rows 20240731_9089e23e-ca4a-454f-8dcc-ff5a29a5a335.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 41 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Astringent Solution ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE First Nation Group 065c895c-7d86-f1ed-e063-6394a90a3a52 2025-07-07 Warnings Exact identifier application number: M016 Creamy Petroleum PETROLATUM Savvy Care & Cosmetics Pvt Ltd 3916daee-f8d2-e3f0-e063-6294a90a3883 2025-07-04 Warnings Exact identifier application number: M016 Exemax Cream DIMETHICONE, ALLANTOIN PureTek Corporation 38e79055-df84-d314-e063-6394a90ac95f 2025-07-01 Warnings Exact identifier application number: M016 Procure Dimethicone 5% DIMETHICONE Twin Med LLC 38a7e4af-997d-549e-e063-6394a90a0bd6 2025-06-28 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE OINTMENT Derma Sciences Canada Inc. 37eff762-1ea9-ec66-e063-6394a90a3d10 2025-06-19 Warnings Exact identifier application number: M016 Dr.Johnes SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC b731c55e-31ee-429f-8432-fac7c5718d83 2025-06-18 Warnings Exact identifier application number: M016 Dr. Johne SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC 6c5adc3c-9d45-449a-ad42-f9571851cd18 2025-06-18 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal OATMEAL THERAPLEX, LLC e51aa467-ffe7-4c6b-8588-6df8592596d4 2025-06-16 Warnings Exact identifier application number: M016 ZIIDII Wild Yam Cream WILD YAM Guangzhou Haishi Biological Technology Co., Ltd. 3733154a-4884-9988-e063-6294a90aa78c 2025-06-10 Warnings Exact identifier application number: M016 Aveeno Calm Plus Restore Skin Therapy Balm COLLOIDAL OATMEAL Kenvue Brands LLC dbe7a2cc-9c21-2a48-e053-2a95a90a54e2 2025-06-04 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM WALGREENS 2017113f-d192-5fbb-e063-6294a90a83b0 2025-05-31 Warnings Exact identifier application number: M016 AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Exact identifier application number: M016 SupreH Bee Venom Skin Tag Treatment Liquid SUPREH BEE VENOM SKIN TAG REMOVER LIQUID Shenzhen Xinxin Yunhai Technology Co., Ltd. 35ca9836-917a-b0ac-e063-6294a90a28a2 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Bed Sore Relief ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d2738c-dacf-7309-e063-6294a90aab4c 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions fd6bf169-f1e2-48d4-b98d-8f3c39981a89 2025-05-23 Warnings Exact identifier application number: M016 Perfect 10 Soothing Recovery PETROLATUM Topiderm, Inc. e3a4f038-d084-4d77-bd35-13f41856a615 2025-04-30 Warnings Exact identifier application number: M016 Diabetic Advanced Healing Cream DIMETHICONE Neoteric Cosmetics, Inc. 46996845-9398-41d8-bf99-79f6a29bec28 2025-04-30 Warnings Exact identifier application number: M016 BabyDiaperCream BABY DIAPER CREAM Whole Foods Market d7b19529-d0b2-638b-e053-2a95a90acf2f 2025-04-29 Warnings Exact identifier application number: M016 ChapIce Moisture SPF 15 Lip Balm OXYBENZONE, OCTINOXATE, PETROLATUM Navajo Manufacturing Company Inc. 60ce1a8c-180a-161e-e053-2991aa0ae981 2025-04-29 Warnings Exact identifier application number: M016 Assurance Barrier Cream DIMETHICONE CREAM Walmart Inc 23a2a04f-71ce-4fa1-e063-6394a90a649e 2025-04-22 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 Sample Exclude flag Status 11344-136-30 11344013630 177 mL in 1 BOTTLE, PLASTIC (11344-136-30) 177 ml 2016-09-08 No No Current