Earache Drops

Product NDC: 53799-405
Requested package NDC: 53799-405-11
11-digit product format: 537990405
Labeler code: 53799
Product ID: 53799-405_89edf769-8377-4ab3-bd37-5f12a07ac7ee
Type: HUMAN OTC DRUG
Nonproprietary name: Chamomilla, Mercurius Solubilis and Sulphur
Dosage form: SOLUTION/ DROPS
Route: AURICULAR (OTIC)
Labeler: Similasan AG
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2021-09-16
Marketing end: 0000-00-00
Substance: CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR
Active strength: 10 [hp_X]/10mL; [hp_X]/10mL; [hp_X]/10mL
NDC exclude flag: No
Listing certified through: 2024-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53799-405	53799-405-11	I	Inactivated by FDA		2026-09-14

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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53799-405-11	2025-01-30	C162847	48780-1	2cef2736-a3da-d83d-e063-dadaa90ab31f	Walgreens Earache Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53799-405-11	Earache Drops	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53799-405	EARACHE DROPS (CHAMOMILLA, MERCURIUS SOLUBILIS AND SULPHUR) SOLUTION/ DROPS [SIMILASAN AG]	2	Legacy NDC, 1 package rows	20230106_4dd41edd-84a5-4e13-b6a9-7d6000ad787f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FGL3685T2X	CHAMOMILE		CHAMOMILE
324Y4038G2	MERCURIUS SOLUBILIS		MERCURIUS SOLUBILIS
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
53799-405-11	53799040511	10 mL in 1 BOTTLE, DROPPER (53799-405-11)	10 ml	2021-09-16	0000-00-00	No	No	Current