Kids Earache Relief

Product NDC: 53799-279
11-digit product format: 537990279
Labeler code: 53799
Product ID: 53799-279_17164dc7-5682-4275-9b5a-a3c00cbac91b
Type: HUMAN OTC DRUG
Nonproprietary name: Matricaria recutita, Mercurius Solubilis, Anemone patens and Sulphur
Dosage form: SOLUTION
Route: AURICULAR (OTIC)
Labeler: Similasan AG
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2018-07-20
Marketing end: 0000-00-00
Substance: MATRICARIA CHAMOMILLA; MERCURIUS SOLUBILIS; PULSATILLA PATENS WHOLE; SULFUR
Active strength: 10 [hp_X]/10mL; [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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53799-279		I	Inactivated by FDA		2026-10-05
excluded package	package	53799-279	53799-279-11	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53799-279-11	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53799-279-11	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53799-279-11	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53799-279-11	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53799-279-11	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53799-279-11	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53799-279-11	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53799-279-11	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53799-279-11	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53799-279-11	2025-01-30	C162847	48780-1	2cef2736-8362-d83d-e063-dadaa90ab31f	Kids Earache Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53799-279-11	Kids Earache Relief	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		3
53799-279-11	Kids Earache Relief	1 in 1 BOX	SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53799-279	KIDS EARACHE RELIEF (MATRICARIA RECUTITA, MERCURIUS SOLUBILIS, ANEMONE PATENS AND SULPHUR) SOLUTION [SIMILASAN AG]	3	Legacy NDC, 2 package rows	20230106_8964865b-b9bb-4591-bd22-635ec0e2b13c.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G0R4UBI2ZZ	MATRICARIA CHAMOMILLA		MATRICARIA CHAMOMILLA
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	Marketing start	Marketing end	Sample	Exclude flag	Status
53799-279-11	53799027911	1 BOTTLE, DROPPER in 1 BOX (53799-279-11) > 10 mL in 1 BOTTLE, DROPPER	2018-07-20	0000-00-00	No	No	Current