FDA.reportPublic FDA data

Calamine

Product NDC
0363-0224
11-digit product format
003630224
Labeler code
0363
Product ID
0363-0224_1c272ec5-05a8-4ec1-bf80-d07ea750b23d
Type
HUMAN OTC DRUG
Nonproprietary name
FERRIC OXIDE RED
Dosage form
LOTION
Route
TOPICAL
Labeler
Walgreen Co.
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1996-01-05
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; ZINC OXIDE
Active strength
8 g/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 productproduct0363-0224DDiscontinued by firm2026-08-11
excluded packagepackage0363-02240363-0224-30DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct0363-0224DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-02240363-0224-30DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERRIC OXIDE REDACTIVE INGREDIENT1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
FERRIC OXIDE REDACTIVE MOIETY1K09F3G675CALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
BENTONITEINACTIVE INGREDIENTA3N5ZCN45CCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VNCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RCALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0224CALAMINE (FERRIC OXIDE RED) LOTION [WALGREEN CO.]14Legacy NDC20250417_a1efa816-792c-4f71-a473-324852574b80.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0224-3000363022430177 mL in 1 BOTTLE, PLASTIC (0363-0224-30) 177 ml1996-01-050000-00-00NoNoCurrent