FDA.reportPublic FDA data

Pure Carnation

Product NDC
42498-001
Requested package NDC
42498-001-08
11-digit product format
424980001
Labeler code
42498
Product ID
42498-001_5f5f04ac-3ffb-4ed2-a33b-dbdbb2fcf140
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Eng Kah Enterprise Sdn.Bhd
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
77 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage42498-00142498-001-08IInactivated by FDA2026-10-15

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
42498-001-016b476122-c870-4e09-90ed-24d62d49ca41
42498-001-026b476122-c870-4e09-90ed-24d62d49ca41
42498-001-036b476122-c870-4e09-90ed-24d62d49ca41
42498-001-046b476122-c870-4e09-90ed-24d62d49ca41
42498-001-056b476122-c870-4e09-90ed-24d62d49ca41
42498-001-066b476122-c870-4e09-90ed-24d62d49ca41
42498-001-076b476122-c870-4e09-90ed-24d62d49ca41
42498-001-086b476122-c870-4e09-90ed-24d62d49ca41
42498-001-096b476122-c870-4e09-90ed-24d62d49ca41
42498-001-106b476122-c870-4e09-90ed-24d62d49ca41
42498-001-116b476122-c870-4e09-90ed-24d62d49ca41

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42498-001-01Pure Carnation50 mL in 1 BOTTLEGEL501
42498-001-02Pure Carnation60 mL in 1 BOTTLEGEL601
42498-001-03Pure Carnation120 mL in 1 BOTTLEGEL1201
42498-001-04Pure Carnation250 mL in 1 BOTTLEGEL2501
42498-001-05Pure Carnation500 mL in 1 BOTTLEGEL5001
42498-001-06Pure Carnation600 mL in 1 BOTTLEGEL6001
42498-001-07Pure Carnation750 mL in 1 BOTTLEGEL7501
42498-001-08Pure Carnation1000 mL in 1 BOTTLEGEL10001
42498-001-09Pure Carnation5000 mL in 1 BOTTLEGEL50001
42498-001-10Pure Carnation20000 mL in 1 BOTTLEGEL200001
42498-001-11Pure Carnation25000 mL in 1 BOTTLEGEL250001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42498-001PURE CARNATION (ALCOHOL) GEL [ENG KAH ENTERPRISE SDN.BHD]1Legacy NDC, 11 package rows20200612_6b476122-c870-4e09-90ed-24d62d49ca41.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42498-001-08424980001081000 mL in 1 BOTTLE (42498-001-08) 1000 ml2020-06-080000-00-00NoNoCurrent