FDA.reportPublic FDA data

Proflexa

Product NDC
83011-001
Requested package NDC
83011-001-01
11-digit product format
830110001
Labeler code
83011
Product ID
83011-001_e9ebcd18-e22a-78b0-e053-2995a90acd1f
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor
Dosage form
CREAM
Route
TOPICAL
Labeler
Sinoveda Canada Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-09-30
Marketing end
0000-00-00
Substance
CAMPHOR (NATURAL)
Active strength
3 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 packagepackage83011-00183011-001-01IInactivated 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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83011-001-012024-07-30C16284748780-11030e365-328e-111a-e063-dadaa90a10e2Proflexa
83011-001-012024-01-30C16284748780-11030e365-328e-111a-e063-dadaa90a10e2Proflexa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83011-001-01Proflexa1 in 1 CARTONCREAM11
83011-001-01Proflexa50 g in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83011-001PROFLEXA (CAMPHOR) CREAM [SINOVEDA CANADA INC]1Legacy NDC, 2 package rows20221027_e9ebcd18-e229-78b0-e053-2995a90acd1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2619330camphor 3.3 % Topical CreamPSNe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619335PROFLEXA 3.3 % Topical CreamPSNe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619335camphor 33 MG/ML Topical Cream [Proflexa]SBDe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619330camphor 33 MG/ML Topical CreamSCDe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619330camphor 3.3 % Topical CreamSYe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619335Proflexa 3.3 % Topical CreamSYe9ebcd18-e229-78b0-e053-2995a90acd1f1
2619335Proflexa 33 MG/ML Topical CreamSYe9ebcd18-e229-78b0-e053-2995a90acd1f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83011-001-01830110001011 TUBE in 1 CARTON (83011-001-01) > 50 g in 1 TUBE1 tube2022-09-300000-00-00NoNoCurrent