BM Natural Mullein Ear

Product NDC: 85816-6015
11-digit product format: 858166015
Labeler code: 85816
Product ID: 85816-6015_3890707a-d9b7-f1bd-e063-6394a90a3308
Type: HUMAN OTC DRUG
Nonproprietary name: Belladonna, Calendula, Echinacea, Hydrastis, Mullein oil, Viola odorata
Dosage form: SOLUTION/ DROPS
Route: AURICULAR (OTIC)
Labeler: BM Private Limited
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2015-01-01
Substance: VIOLA ODORATA; ATROPA BELLADONNA; CALENDULA OFFICINALIS FLOWERING TOP; VERBASCUM THAPSUS; ECHINACEA, UNSPECIFIED; GOLDENSEAL
Active strength: 1; 10; 1; 1; 1; 3 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: BM Natural Mullein Ear
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VIOLA ODORATA	1 [hp_X]/mL
ATROPA BELLADONNA	10 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]/mL
VERBASCUM THAPSUS	1 [hp_X]/mL
ECHINACEA, UNSPECIFIED	1 [hp_X]/mL
GOLDENSEAL	3 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
AET12U8B74	Internal UNII lookup
WQZ3G9PF0H	Internal UNII lookup
18E7415PXQ	Internal UNII lookup
C9TD27U172	Internal UNII lookup
4N9P6CC1DX	Internal UNII lookup
ZW3Z11D0JV	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3890707a-d9b6-f1bd-e063-6394a90a3308	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85816-6015-1	BM Natural Mullein Ear	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BM Natural Mullein Ear	BELLADONNA, CALENDULA, ECHINACEA, HYDRASTIS, MULLEIN OIL, VIOLA ODORATA	BM Private Limited	3890707a-d9b6-f1bd-e063-6394a90a3308	2025-06-27	Warnings	Exact identifier ndc (product): 85816-6015

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
AET12U8B74	VIOLA ODORATA	VIOLA ODORATA
WQZ3G9PF0H	ATROPA BELLADONNA	ATROPA BELLADONNA
18E7415PXQ	CALENDULA OFFICINALIS FLOWERING TOP	CALENDULA OFFICINALIS FLOWERING TOP
C9TD27U172	VERBASCUM THAPSUS	VERBASCUM THAPSUS
4N9P6CC1DX	ECHINACEA, UNSPECIFIED	ECHINACEA, UNSPECIFIED
ZW3Z11D0JV	GOLDENSEAL	GOLDENSEAL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85816-6015-1	85816601501	15 mL in 1 BOTTLE, DROPPER (85816-6015-1)	15 ml	2015-01-01	No	No	Current