Kids Pink Eye Relief

Product NDC: 53799-368
11-digit product format: 537990368
Labeler code: 53799
Product ID: 53799-368_2f17982f-cc1c-41b3-a821-b35c46e7c6ef
Type: HUMAN OTC DRUG
Nonproprietary name: ATROPA BELLADONNA, CALCIUM SULFIDE, EUPHRASIA STRICTA and PLATYCLADUS ORIENTALIS LEAF
Dosage form: LIQUID
Route: OPHTHALMIC
Labeler: Similasan AG
Marketing category: UNAPPROVED HOMEOPATHIC
Marketing start: 2018-11-15
Marketing end: 0000-00-00
Substance: ATROPA BELLADONNA; CALCIUM SULFIDE; EUPHRASIA STRICTA; PLATYCLADUS ORIENTALIS LEAF
Active strength: 6 [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	53799-368		I	Inactivated by FDA		2026-10-12
excluded package	package	53799-368	53799-368-11	I	Inactivated by FDA		2026-10-12

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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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	53799-368-11	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
53799-368-11	2025-01-30	C162847	48780-1	2cef2736-76a7-d83d-e063-dadaa90ab31f	Kids Pink Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53799-368-11	Kids Pink Eye Relief	10 mL in 1 BOTTLE, DROPPER	LIQUID	10		2
53799-368-11	Kids Pink Eye Relief	1 in 1 CARTON	LIQUID	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53799-368	KIDS PINK EYE RELIEF (ATROPA BELLADONNA, CALCIUM SULFIDE, EUPHRASIA STRICTA AND PLATYCLADUS ORIENTALIS LEAF) LIQUID [SIMILASAN AG]	2	Legacy NDC, 2 package rows	20230106_a838d38a-b4d2-4b59-ab67-74a3c8e38077.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WQZ3G9PF0H	ATROPA BELLADONNA		ATROPA BELLADONNA
1MBW07J51Q	CALCIUM SULFIDE	20548-54-3	CALCIUM SULFIDE
C9642I91WL	EUPHRASIA STRICTA		EUPHRASIA STRICTA
32E5V7G32B	PLATYCLADUS ORIENTALIS LEAF		PLATYCLADUS ORIENTALIS LEAF

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53799-368-11	53799036811	1 BOTTLE, DROPPER in 1 CARTON (53799-368-11) > 10 mL in 1 BOTTLE, DROPPER	2018-11-15	0000-00-00	No	No	Current