FDA.reportPublic FDA data

Calamine

Product NDC
55316-063
11-digit product format
553160063
Labeler code
55316
Product ID
55316-063_c157b5cb-59d7-4455-9624-4f20e3ca9e20
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
DZB Brands, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2008-02-05
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
80 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55316-063DDiscontinued by firm2026-08-11
excluded packagepackage55316-06355316-063-26DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-063-26d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-063-26f5e01cc5f278…a2eaf40c39c3…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNCALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALAMINE (FERRIC OXIDE RED) LOTION [DZB BRANDS, LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55316-063-2655316006326177 mL in 1 BOTTLE, PLASTIC (55316-063-26) 177 ml2008-02-050000-00-00NoNoCurrent