Artificial Tears

Product NDC: 13985-601
11-digit product format: 139850601
Labeler code: 13985
Product ID: 13985-601_3f0ac098-2e15-4967-a9c6-e061e4388755
Type: HUMAN OTC DRUG
Nonproprietary name: Polyvinyl Alcohol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: MWI
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-03-23
Marketing end: 0000-00-00
Substance: POLYVINYL ALCOHOL, UNSPECIFIED
Active strength: 14 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	13985-601		I	Inactivated by FDA		2026-08-17
excluded package	package	13985-601	13985-601-15	I	Inactivated by FDA		2026-08-17

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 · 30 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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`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	13985-601-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	13985-601-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	13985-601-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13985-601-15	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13985-601-15	2024-01-30	C162847	48780-1	1030e365-6556-111a-e063-dadaa90a10e2	b6bf402a-fe57-4998-b85e-a262c25e745a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13985-601-15	Artificial Tears	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		5
13985-601-15	Artificial Tears	1 in 1 CARTON	SOLUTION/ DROPS	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Polyvinyl Alcohol	ACTIVE INGREDIENT	532B59J990	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Polyvinyl Alcohol	ACTIVE MOIETY	532B59J990	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Sodium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	22ADO53M6F	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Sodium Phosphate, Monobasic, Anhydrous	INACTIVE INGREDIENT	KH7I04HPUU	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13985-601	ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION/ DROPS [MWI]	5	Legacy NDC, 2 package rows	20220209_b6bf402a-fe57-4998-b85e-a262c25e745a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
532B59J990	POLYVINYL ALCOHOL, UNSPECIFIED	9002-89-5	POLYVINYL ALCOHOL, UNSPECIFIED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	PSN	b6bf402a-fe57-4998-b85e-a262c25e745a	5
142004	polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution	SCD	b6bf402a-fe57-4998-b85e-a262c25e745a	5
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	SY	b6bf402a-fe57-4998-b85e-a262c25e745a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13985-601-15	13985060115	1 BOTTLE, DROPPER in 1 CARTON (13985-601-15) > 15 mL in 1 BOTTLE, DROPPER	2015-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Artificial Tears - MWI \| Akorn Operating Company LLC \| Akorn	MWI \| Akorn Operating Company LLC \| Akorn	2022-02-08	HUMAN OTC DRUG LABEL	5