FLORIL TEARS

Product NDC: 16995-004
11-digit product format: 169950004
Labeler code: 16995
Product ID: 16995-004_94f2f212-eba2-47a6-96ac-9f9639e2a09d
Type: HUMAN OTC DRUG
Nonproprietary name: POLYVINYL ALCOHOL
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: VITALINE S.A.C.
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2005-11-10
Marketing end: 0000-00-00
Substance: POLYVINYL ALCOHOL
Active strength: 14 mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16995-004		I	Inactivated by FDA	2026-10-05
excluded package	package	16995-004	16995-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	16995-004	16995-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	16995-004	16995-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	16995-004	16995-004-04	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 2 · 110 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16995-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16995-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16995-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16995-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16995-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16995-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16995-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16995-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16995-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16995-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16995-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16995-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16995-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16995-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16995-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16995-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16995-004-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16995-004-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16995-004-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16995-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16995-004-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16995-004-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16995-004-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16995-004-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16995-004-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16995-004-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16995-004-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16995-004-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16995-004-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16995-004-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16995-004-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16995-004-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16995-004-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16995-004-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16995-004-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16995-004-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16995-004-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16995-004-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16995-004-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16995-004-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16995-004-03	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16995-004-04	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16995-004-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16995-004-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16995-004-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16995-004-04	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16995-004-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	16995-004-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
16995-004-01	8101c006-0b47-4484-8760-a959764f555c
16995-004-02	8101c006-0b47-4484-8760-a959764f555c
16995-004-03	8101c006-0b47-4484-8760-a959764f555c
16995-004-04	8101c006-0b47-4484-8760-a959764f555c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16995-004-01	FLORIL TEARS	3 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	3	1
16995-004-02	FLORIL TEARS	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	1
16995-004-03	FLORIL TEARS	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	1
16995-004-04	FLORIL TEARS	30 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	30	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYVINYL ALCOHOL	ACTIVE INGREDIENT	532B59J990	FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]	1
POLYVINYL ALCOHOL	ACTIVE MOIETY	532B59J990	FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]	1
POLYETHYLENE GLYCOL 300	INACTIVE INGREDIENT	5655G9Y8AQ	FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16995-004	FLORIL TEARS (POLYVINYL ALCOHOL ) SOLUTION/ DROPS [VITALINE S.A.C.]	1	Legacy NDC, 4 package rows	20100629_8101c006-0b47-4484-8760-a959764f555c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1039907	Floril TEARS 0.2 % / 1.4 % Ophthalmic Solution	PSN	8101c006-0b47-4484-8760-a959764f555c	1
1039905	polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic Solution	PSN	8101c006-0b47-4484-8760-a959764f555c	1
1039907	polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution [Floril Tears]	SBD	8101c006-0b47-4484-8760-a959764f555c	1
1039905	polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution	SCD	8101c006-0b47-4484-8760-a959764f555c	1
1039907	Floril Tears (polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % ) Ophthalmic Solution	SY	8101c006-0b47-4484-8760-a959764f555c	1
1039907	Floril Tears (polyethylene glycol 400 2 MG/ML / polyvinyl alcohol 0.014 ML/ML) Ophthalmic Solution	SY	8101c006-0b47-4484-8760-a959764f555c	1
1039905	polyethylene glycol 400 0.2 % / polyvinyl alcohol 1.4 % Ophthalmic Solution	SY	8101c006-0b47-4484-8760-a959764f555c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
16995-004-01	16995000401	3 mL in 1 BOTTLE, DROPPER	3 ml	Historical
16995-004-02	16995000402	10 mL in 1 BOTTLE, DROPPER	10 ml	Historical
16995-004-03	16995000403	15 mL in 1 BOTTLE, DROPPER	15 ml	Historical
16995-004-04	16995000404	30 mL in 1 BOTTLE, DROPPER	30 ml	Historical