Owell Naturals Draw Salve

Product NDC
83570-487
11-digit product format
835700487
Labeler code
83570
Product ID
83570-487_3ea05822-8697-4456-e063-6294a90a5bad
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica Montana HPUS, Silicea HPUS
Dosage form
SALVE
Route
TOPICAL
Labeler
Owell Naturals Brand LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-04-02
Substance
ARNICA MONTANA FLOWER; SILICON DIOXIDE
Active strength
.283; .0283 g/28.3g; g/28.3g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Owell Naturals Draw Salve
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA FLOWER.283 g/28.3g
SILICON DIOXIDE.0283 g/28.3g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOZ0E5Y15PZ, ETJ7Z6XBU4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83570-487-012025-09-12C16284748780-13b156c62-2a6b-fb37-e063-e6dba90a4e07Owell Naturals Draw Salve
83570-487-012025-07-29C16284748780-13b156c62-2a6b-fb37-e063-e6dba90a4e07Owell Naturals Draw Salve
83570-487-022025-07-29C16284748780-13b156c62-33a1-fb37-e063-e6dba90a4e07Owell Naturals Draw Salve

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83570-487-01Owell Naturals Draw Salve28.3 g in 1 JARSALVE28.33
83570-487-02Owell Naturals Draw Salve56 g in 1 JARSALVE561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83570-487OWELL NATURALS DRAW SALVE (ARNICA MONTANA HPUS, SILICEA HPUS) SALVE [OWELL NATURALS BRAND LLC]2Current NDC, 1 package rows20240707_1536ff1e-16b8-fbbc-e063-6394a90a628e.zip
83570-487OWELL NATURALS DRAW SALVE (ARNICA MONTANA HPUS, SILICEA HPUS) SALVE [OWELL NATURALS BRAND LLC]1Current NDC, 1 package rows20240703_1b2f505c-d850-e5ca-e063-6394a90a486b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83570-487-018357004870128.3 g in 1 JAR (83570-487-01) 28.3 g2024-04-02NoNoCurrent
83570-487-028357004870256 g in 1 JAR56 gHistorical