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 14 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ChapStick Classic Variety-Classic Cherry-Classic Strawberry-Classic Spearmint SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4523af69-1a0d-6d18-e063-6394a90ad9d1 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me Cherry LIP BALM SKIN PROTECTANT Suave Brands Company 47a2487d-b2e5-7195-e063-6394a90ae481 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Cherry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 4512b5a0-ce1f-c53e-e063-6294a90a56b6 2026-03-30 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry SKIN PROTECTANT LIP BALM Suave Brands Co., LLC 42770fff-d70a-d9d1-e063-6294a90aa98d 2026-03-30 Warnings Exact identifier application number: M016 Aveeno Skin Relief Healing GLYCERIN Kenvue Brands LLC 345fdde5-700b-7103-e063-6394a90a0e3e 2026-03-27 Warnings Exact identifier application number: M016 Critic Aid Clear PETROLATUM Coloplast Corp 0b6da97e-519b-4579-9895-f4ede5c48b47 2026-03-27 Warnings Exact identifier application number: M016 Baza Protect ZINC OXIDE AND DIMETHICONE Coloplast Corp 256dfcfc-a91c-49b0-9439-452586a0880e 2026-03-27 Warnings Exact identifier application number: M016 Sween 24 DIMETHICONE Coloplast Corp a623c8d7-8db0-410a-9980-02ac02f7b6ea 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect Odor Control DIMETHICONE Coloplast Corp ca5fa4ae-c18d-4457-b520-4a9318ea821f 2026-03-27 Warnings Exact identifier application number: M016 Baza Cleanse and Protect DIMETHICONE Coloplast Corp 82eff041-0c9d-4261-a6b6-5a041a660074 2026-03-27 Warnings Exact identifier application number: M016 Baza Clear PETROLATUM Coloplast Corp 69d9f456-1a35-4146-8366-c0285648a172 2026-03-27 Warnings Exact identifier application number: M016 Vitamin A D LANOLIN, PETROLATUM Topco Associates LLC 5126fdf6-5df5-474b-bc0d-3a82dea61abb 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Advanced Healing PETROLATUM Amazon.com Services LLC cdf1bd12-ac59-4f06-be0f-ef6eb3caeeff 2026-03-26 Warnings, Adverse reactions Exact identifier application number: M016 Dynashield with Dimethicone ZINC OXIDE Dynarex Corporation b5dcf9e8-4689-4a08-ae73-3a859b4cbffe 2026-03-26 Warnings Exact identifier application number: M016 Eczema Relief Cream COLLOIDAL OATMEAL Lavior Pharma Inc bdd2fc9f-2718-1d88-e053-2995a90a8682 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f2dec8-7ffc-fc3e-e063-6294a90a76ff 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f33001-7fec-682e-e063-6394a90a9428 2026-03-26 Warnings Exact identifier application number: M016 FB HYDRATING HAND SANITIZER FB HYDRATING HAND SANITIZER FAMILY DOLLAR SERVICES, LLC 36f3b300-f32f-8881-e063-6394a90a1a2a 2026-03-26 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Dynarex Corporation 81f5092d-0632-bf47-e053-2991aa0ac563 2026-03-25 Warnings Exact identifier application number: M016 MYEVER ESTRIOL CREAM Hubei Redrui Building Materials Co., Ltd. 3ed85485-a441-4c05-e063-6394a90afef5 2026-03-25 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