FDA.reportPublic FDA data

Calamine Plus Pramoxine HCL

Product NDC
41250-235
11-digit product format
412500235
Labeler code
41250
Product ID
41250-235_f2048b24-433e-98ba-e053-2995a90a5e85
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Meijer Distribution Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-14
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength
0 mg/116g; mg/116g; mg/116g
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 productproduct41250-235DDiscontinued by firm2026-10-15
excluded packagepackage41250-23541250-235-41DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-235-41Calamine Plus Pramoxine HCL116 g in 1 CANISTERAEROSOL, SPRAY1166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-235CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.]6Legacy NDC, 1 package rows20241016_902d34b9-6a37-4de7-e053-2a95a90a0a7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544717calamine 8 % / pramoxine HCl 1 % Topical SprayPSN902d34b9-6a37-4de7-e053-2a95a90a0a7b6
1544717calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical SpraySCD902d34b9-6a37-4de7-e053-2a95a90a0a7b6
1544717calamine 8 % / pramoxine hydrochloride 1 % Topical SpraySY902d34b9-6a37-4de7-e053-2a95a90a0a7b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-235-4141250023541116 g in 1 CANISTER (41250-235-41) 116 g2020-03-140000-00-00NoNoCurrent