FDA.reportPublic FDA data

Hylands Naturals Diaper Rash Cream

Product NDC
54973-4101
11-digit product format
549734101
Labeler code
54973
Product ID
54973-4101_a738feda-9c40-4a82-97d6-ab6c79ed38f3
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Hylands
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-12-05
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
10 g/100g
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 productproduct54973-4101DDiscontinued by firm2026-10-05
excluded packagepackage54973-410154973-4101-1DDiscontinued 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 · 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
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct54973-4101UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54973-410154973-4101-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
54973-4101HYLANDS NATURALS DIAPER RASH CREAM (ZINC OXIDE) CREAM [HYLANDS]4Legacy NDC20250116_0d880bd9-e016-4132-ae42-68e20f5cea2d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-4101-1549734101011 TUBE in 1 BOX (54973-4101-1) > 85 g in 1 TUBE1 tube2022-12-050000-00-00NoNoCurrent