Home NDC 75981-063 Calamine
Product NDC 75981-063
11-digit product format 759810063
Labeler code 75981
Product ID 75981-063_4b30bf8c-4f51-f880-e063-6294a90a8f77
Type HUMAN OTC DRUG
Nonproprietary name FERRIC OXIDE RED
Dosage form LOTION
Route TOPICAL
Labeler Perrigo Direct, Inc�
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-09-15
Substance FERRIC OXIDE RED; ZINC OXIDE
Active strength 8; 8 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 8 mg/mL ZINC OXIDE 8 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 SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 617954 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75981-063-30 Calamine 177 mL in 1 BOTTLE, PLASTIC LOTION 177 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 BENTONITE INACTIVE INGREDIENT A3N5ZCN45C CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 CALCIUM HYDROXIDE INACTIVE INGREDIENT PF5DZW74VN CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CALAMINE (FERRIC OXIDE RED) LOTION [GEISS, DESTIN AND DUNN, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75981-063 CALAMINE (FERRIC OXIDE RED) LOTION [PERRIGO DIRECT, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250410_256bd1d4-fd50-408f-9aee-84f218bb4971.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 27 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eucerin Eczema Relief Body OATMEAL Beiersdorf Inc 9895f3c3-b00b-462c-ace0-696d688e2e04 2025-12-31 Warnings Exact identifier application number: M016 Eucerin Eczema Relief Flare Up Treatment OATMEAL Beiersdorf Inc a9ea4832-3211-40b2-accf-90ace7b9e279 2025-12-31 Warnings Exact identifier application number: M016 Eczema Relief Cream Body Wash OATMEAL Beiersdorf Inc f12644e5-0ff0-de0e-e053-2995a90a0995 2025-12-31 Warnings Exact identifier application number: M016 XIMONTH Honey Eye Drops GLYCERIN Shantou Ximonth Biotechnology Co., Ltd. 4727f304-0bc7-2fee-e063-6394a90a0178 2025-12-30 Warnings Exact identifier application number: M016 Kinfield Relief Balm Anti-Itch Remedy KINFIELD RELIEF BALM ANTI-ITCH REMEDY Kinfield, Inc. bf394192-c789-faff-e053-2995a90a52bc 2025-12-30 Warnings Exact identifier application number: M016 911 ALLANTOIN Skinfix, Inc. f28c251e-a91b-4ed4-8224-b47c345f982f 2025-12-29 Warnings Exact identifier application number: M016 EXTRA STRENGTH BODY COLLOIDAL OATMEAL Skinfix, Inc. 32ba5f29-c037-44dd-b5b1-59001ac50753 2025-12-29 Warnings Exact identifier application number: M016 VITACILINA Bebe Diaper Rash ALLANTOIN, ZINC OXIDE Compania Internacional de Comercio, S.A.P.I de C.V. 39726b59-bd85-4541-80e5-4f2919842dca 2025-12-29 Warnings Exact identifier application number: M016 Creamy Diaper Rash ZINC OXIDE Davion, Inc 0fdfe7d3-e4cd-6bea-e063-6394a90a37f6 2025-12-29 Warnings Exact identifier application number: M016 Medicated Cornstarch Baby Powder ACTIVE CORN STARCH Davion, Inc. e39032d1-c8cd-4a41-af10-126970b8ad38 2025-12-29 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dcf0b2-4f9f-023a-e053-2995a90a183a 2025-12-28 Warnings Exact identifier application number: M016 WinCo FoodsPetroleum Jelly WHITE PETROLATUM WinCo Foods, LLC f5dca60a-e9bc-4161-e053-2995a90a2bcb 2025-12-28 Warnings Exact identifier application number: M016 Hydrating Healing HYDRATING HEALING OINTMENT Neilmed Pharmaceuticals Inc., 47106abb-4c39-07d9-e063-6394a90a4fae 2025-12-28 Warnings Exact identifier application number: M016 TCX Skincare COLLOIDAL OATMEAL Theraceutix, LLC c3be950b-28cf-47c2-9570-ebd46e43b1ba 2025-12-24 Warnings Exact identifier application number: M016 Nizoral Eczema Relief Cream COLLOIDAL OATMEAL Kramer Laboratories da3a39d7-197f-4451-9d24-f92adbe0fc19 2025-12-23 Warnings Exact identifier application number: M016 Healing Head to Toe ALLANTOIN The Honest Company, Inc dc02033f-8116-1710-e053-2995a90aff69 2025-12-23 Warnings Exact identifier application number: M016 Honest Eczema Cream COLLOIDAL OATMEAL The Honest Company, Inc. 6f111094-425b-4a8c-b71a-5ff65f4a8000 2025-12-23 Warnings Exact identifier application number: M016 BABY ANTI MONKEY BUTT DIAPER RASH ZINC OXIDE, CALAMINE Clarion Brands, LLC e4424d74-f89c-5943-42e8-bf3a38e68619 2025-12-23 Warnings Exact identifier application number: M016 Dissolvable Microneedle Eye Patches ALLANTOIN Advaccine Biopharmaceuticals Suzhou Co., Ltd 4684fa4e-5c5e-045d-e063-6394a90af069 2025-12-22 Warnings Exact identifier application number: M016 Good Neighbor Petroleum Jelly WHITE PETROLATUM AmerisourceBergen e5fb80a0-cc8c-e9e7-e053-2a95a90a455d 2025-12-22 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 Marketing end Sample Exclude flag Status 75981-063-30 75981006330 177 mL in 1 BOTTLE, PLASTIC (75981-063-30) 177 ml 1992-09-15 0000-00-00 No No Current