Similasan Earache Relief

Product NDC: 59262-271
Requested package NDC: 59262-271-11
11-digit product format: 592620271
Labeler code: 59262
Product ID: 59262-271_585221bc-a415-4f63-e063-6294a90a2df5
Type: HUMAN OTC DRUG
Nonproprietary name: CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR
Dosage form: SOLUTION/ DROPS
Route: AURICULAR (OTIC)
Labeler: Similasan Corporation
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2013-07-02
Substance: MERCURIUS SOLUBILIS; CHAMOMILE; SULFUR
Active strength: 15; 10; 12 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59262-271	59262-271-11	D	Discontinued by firm		2026-10-02

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 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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: Similasan Earache Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MERCURIUS SOLUBILIS	15 [hp_X]/10mL
CHAMOMILE	10 [hp_X]/10mL
SULFUR	12 [hp_X]/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
324Y4038G2	Internal UNII lookup
FGL3685T2X	Internal UNII lookup
70FD1KFU70	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
3b48e1d5-5e74-415b-a460-e4d96899dbb6	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Indexing SPL, Related label table
Effective	Indexing SPL	Related label
2025-02-28	2cef2736-9297-d83d-e063-dadaa90ab31f	Similasan Earache Relief
2025-02-28	2cef2736-9297-d83d-e063-dadaa90ab31f	Similasan Earache Relief
2025-01-30	2cef2736-9297-d83d-e063-dadaa90ab31f	Similasan Earache Relief
2025-01-30	2cef2736-9297-d83d-e063-dadaa90ab31f	Similasan Earache Relief
2020-10-05	9d75b9d1-2379-f424-e053-dadaa90a57ce	Earache Relief
2020-01-31	9d75b9d1-2379-f424-e053-dadaa90a57ce	Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59262-271-11	Similasan Earache Relief	10 mL in 1 BOTTLE, GLASS	SOLUTION/ DROPS	10		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59262-271-11	ML - Milliliter	59262-271	76d2b47f-d500-4478-bb00-03dcf1f8066a	1	2015-10-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59262-271	SIMILASAN EARACHE RELIEF (CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR) SOLUTION/ DROPS [SIMILASAN CORPORATION]	3	Current NDC, Legacy NDC, 1 package rows	20250302_3b48e1d5-5e74-415b-a460-e4d96899dbb6.zip

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
Similasan Earache Relief	CHAMOMILE, MERCURIUS SOLUBILIS, SULFUR	Similasan Corporation	3b48e1d5-5e74-415b-a460-e4d96899dbb6	2026-08-05	Warnings	Exact identifier ndc (package): 59262-271-11 ndc (product): 59262-271 ndc11 (package): 59262027111

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
324Y4038G2	MERCURIUS SOLUBILIS		MERCURIUS SOLUBILIS
FGL3685T2X	CHAMOMILE		CHAMOMILE
70FD1KFU70	SULFUR	7704-34-9	SULFUR

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59262-271-11	59262027111	10 mL in 1 BOTTLE, GLASS (59262-271-11)	10 ml	2013-07-02	0000-00-00	No	No	Current