FDA.reportPublic FDA data

Calamine Plus Pramoxine HCl

Product NDC
11673-635
11-digit product format
116730635
Labeler code
11673
Product ID
11673-635_c77c3c90-015a-f7aa-e053-2995a90a9171
Type
HUMAN OTC DRUG
Nonproprietary name
Calamine Plus Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Target Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-02-01
Marketing end
0000-00-00
Substance
FERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active strength
0 mg/116g; mg/116g; mg/116g
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 productproduct11673-635DDiscontinued by firm2026-09-14
excluded packagepackage11673-63511673-635-41DDiscontinued 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 packagepackage11673-635-41d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11673-635-41f5e01cc5f278…a2eaf40c39c3…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11673-635-412023-01-31C16284748780-1f386c649-d0fe-0266-e053-dadaa90a7c1aTarget Calamine Plus Spray
11673-635-412023-01-30C16284748780-1f386c649-d0fe-0266-e053-dadaa90a7c1aTarget Calamine Plus Spray

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-635CALAMINE PLUS PRAMOXINE HCL (CALAMINE PLUS SPRAY) AEROSOL, SPRAY [TARGET CORPORATION]8Legacy NDC20241213_9e0174a0-ddd2-4996-9c8c-f5977fd360e2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-635-4111673063541116 g in 1 CANISTER (11673-635-41) 116 g2018-02-010000-00-00NoNoCurrent