MedPath

Bestmade Natural Products - Mullein Ear Drops

Mullein Ear Drops

Approved
Approval ID

299331bd-9318-6d80-e063-6294a90ab889

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Bestmade Natural Products

DUNS: 047124582

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Belladonna, Calendula, Echinacea, Hydrastis, Mullein Oil, Viola Odorata

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82969-6015
Product Classification
G
Generic Name
Belladonna, Calendula, Echinacea, Hydrastis, Mullein Oil, Viola Odorata
Product Specifications
Route of AdministrationAURICULAR (OTIC)
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (7)

ALCOHOLInactive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: 3K9958V90M
Classification: IACT
VERBASCUM THAPSUSActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: C9TD27U172
Classification: ACTIB
ATROPA BELLADONNAActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: WQZ3G9PF0H
Classification: ACTIB
VIOLA ODORATA WHOLEActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: AET12U8B74
Classification: ACTIB
ECHINACEA, UNSPECIFIEDActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: 4N9P6CC1DX
Classification: ACTIB
GOLDENSEALActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: ZW3Z11D0JV
Classification: ACTIB
CALENDULA OFFICINALIS FLOWERING TOPActive
Quantity: 30 [hp_C] in 30 [hp_C]
Code: 18E7415PXQ
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/18/2024

Entire package label

mullein

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/18/2024

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 12/18/2024

How to Use

Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/18/2024

Inactive: Alcohol Base to Preserve Remedy

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/18/2024

Belladonna D10: 0.008mL (HPUS)

Calendula Ø: 0.010mL (HPUS)

Echinacea Ø: 0.002mL (HPUS)

Hydrastis D3: 0.002mL (HPUS)

Mullein Oil Ø: 0.28mL (HPUS)

Viola Odorata Ø: 0.002mL (HPUS)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 12/18/2024

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.
Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/18/2024

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNINGS SECTION

LOINC: 34071-1Updated: 12/18/2024

Warnings and Storage:
Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.
Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.
This product is not intended to diagnose, treat, cure, or prevent any disease.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Bestmade Natural Products - Mullein Ear Drops - FDA Drug Approval Details