Metaderm Eczema Body and Scalp and Baby Body and Scalp

Product NDC
58133-390
Requested package NDC
58133-390-33
11-digit product format
581330390
Labeler code
58133
Product ID
58133-390_7393a857-80cc-64ba-e053-2991aa0a2104
Type
HUMAN OTC DRUG
Nonproprietary name
Achillea millefolium, Aesculus hippocastanum, Berberis vulgaris, Conium maculatum, Matricaria chamomilla, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis
Dosage form
SPRAY
Route
TOPICAL
Labeler
Cosmetic Specialty Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
MATRICARIA CHAMOMILLA FLOWERING TOP OIL; SANGUINARIA CANADENSIS ROOT; ACHILLEA MILLEFOLIUM; BERBERIS VULGARIS FRUIT; CONIUM MACULATUM FRUIT; RHUS SPP. WHOLE; PHYTOLACCA OCTANDRA LEAF; AESCULUS HIPPOCASTANUM SEED OIL
Active strength
5 [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL; [hp_M]/mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage58133-39058133-390-33IInactivated 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 · 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-390-04Metaderm Eczema Body and Scalp and Baby Body and Scalp118 mL in 1 BOTTLE, SPRAYSPRAY1181
58133-390-32Metaderm Eczema Body and Scalp and Baby Body and Scalp950 mL in 1 BOTTLESPRAY9501
58133-390-33Metaderm Eczema Body and Scalp and Baby Body and Scalp950 mL in 1 BOTTLESPRAY9501
58133-390-40Metaderm Eczema Body and Scalp and Baby Body and Scalp118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-390METADERM ECZEMA BODY AND SCALP AND BABY BODY AND SCALP (ACHILLEA MILLEFOLIUM, AESCULUS HIPPOCASTANUM, BERBERIS VULGARIS, CONIUM MACULATUM, MATRICARIA CHAMOMILLA, PHYTOLACCA DECANDRA, RHUS TOXICODENDRON, SANGUINARIA CANADENSIS) SPRAY [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 4 package rows20180817_7393a857-80cb-64ba-e053-2991aa0a2104.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58133-390-3358133039033950 mL in 1 BOTTLE (58133-390-33) 950 ml2018-08-150000-00-00NoNoCurrent