Calamine

Product NDC
41250-888
11-digit product format
412500888
Labeler code
41250
Product ID
41250-888_51bff15a-73d6-4389-b863-c384c6636751
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine, Pramoxine HCl
Dosage form
LOTION
Route
TOPICAL
Labeler
Meijer Distribution
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-06-17
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active strength
80 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 productproduct41250-888DDiscontinued by firm2026-10-05
excluded packagepackage41250-88841250-888-30DDiscontinued by firm2026-10-05

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 packagepackage41250-888-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-888-30f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-888CALAMINE (CALAMINE, PRAMOXINE HCL) LOTION [MEIJER DISTRIBUTION, INC]10Legacy NDC20240830_6cccd2c8-8fc7-41e2-bc8e-b6fdf47d610b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-888-3041250088830177 mL in 1 BOTTLE, PLASTIC (41250-888-30) 177 ml2009-06-170000-00-00NoNoCurrent