FDA.reportPublic FDA data

DermaCerin

Product NDC
61924-174
Requested package NDC
61924-174-16
11-digit product format
619240174
Labeler code
61924
Product ID
61924-174_d58c6a28-840c-4f4b-e053-2a95a90a8187
Type
HUMAN OTC DRUG
Nonproprietary name
Skin Protectant
Dosage form
OINTMENT
Route
TOPICAL
Labeler
DermaRite Industries, LLC
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-10-17
Marketing end
0000-00-00
Substance
PETROLATUM
Active strength
33 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61924-17461924-174-16IInactivated by FDA2026-10-05

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 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61924-174-042026-01-29DermaCerin
61924-174-082026-01-29DermaCerin
61924-174-162026-01-29DermaCerin
61924-174-042024-12-06DermaCerin
61924-174-082024-12-06DermaCerin
61924-174-162024-12-06DermaCerin
61924-174-042024-01-30DermaCerin
61924-174-082024-01-30DermaCerin
61924-174-162024-01-30DermaCerin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-174-04DermaCerin106 g in 1 TUBEOINTMENT1064
61924-174-08DermaCerin198 g in 1 TUBEOINTMENT1984
61924-174-16DermaCerin454 g in 1 JAROINTMENT4544

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-174-04GM - Gram61924-174fa1d5cb2-df3a-443f-a72b-0784c1c3ba3b12025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-174DERMACERIN (SKIN PROTECTANT) OINTMENT [DERMARITE INDUSTRIES, LLC]4Legacy NDC, 3 package rows20241208_5bc3f8a4-a04d-f0c7-e053-2a91aa0a22c4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61924-174-1661924017416454 g in 1 JAR (61924-174-16) 454 g2016-10-170000-00-00NoNoCurrent