Calamine

Product NDC
0363-9114
11-digit product format
003639114
Labeler code
0363
Product ID
0363-9114_f353de8a-8034-417d-ab64-5ed54ec33130
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine, Pramoxind HCl
Dosage form
LOTION
Route
TOPICAL
Labeler
Walgreen CO
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-03-07
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
9 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct0363-9114DDiscontinued by firm2026-09-14
excluded packagepackage0363-91140363-9114-30DDiscontinued by firm2026-09-14

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 packagepackage0363-9114-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-9114-30f5e01cc5f278…a2eaf40c39c3…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9114CALAMINE (CALAMINE, PRAMOXIND HCL) LOTION [WALGREEN CO]9Legacy NDC20240402_856c324d-0683-4a58-a584-0059b0e9b1a5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9114-3000363911430177 mL in 1 BOTTLE, PLASTIC (0363-9114-30) 177 ml2017-03-070000-00-00NoNoCurrent