Premier Value Original

Product NDC: 68016-448
11-digit product format: 680160448
Labeler code: 68016
Product ID: 68016-448_9c4ac509-75b1-4b20-9a2e-381e997e109f
Type: HUMAN OTC DRUG
Nonproprietary name: Tetrahydrozoline Hydrochloride
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Chain Drug Consortium, LLC
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-01-27
Marketing end: 0000-00-00
Substance: TETRAHYDROZOLINE HYDROCHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	68016-448		I	Inactivated by FDA		2026-08-10
excluded package	package	68016-448	68016-448-00	I	Inactivated by FDA		2026-08-10

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 · 42 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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`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	68016-448-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68016-448-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68016-448-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68016-448-00	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68016-448-00	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68016-448-00	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68016-448-00	`9bebd1f3094a…`	`5416666fcb17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
27945931-b6e2-158e-d615-4ef21e2af974	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-448-00	2020-01-31	C162847	48780-1	9d75b9cf-e2af-f424-e053-dadaa90a57ce	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-448-00	Premier Value Original	1 in 1 BOX	SOLUTION/ DROPS	1		2
68016-448-00	Premier Value Original	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-448-00	ML - Milliliter	68016-448	67f2119f-4d12-4f38-9737-24ca873b9d8b	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRAHYDROZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	0YZT43HS7D	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
TETRAHYDROZOLINE	ACTIVE MOIETY	S9U025Y077	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
SODIUM BORATE	INACTIVE INGREDIENT	91MBZ8H3QO	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-448	PREMIER VALUE ORIGINAL (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [CHAIN DRUG CONSORTIUM, LLC]	2	Legacy NDC, 2 package rows	20150106_23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0YZT43HS7D	TETRAHYDROZOLINE HYDROCHLORIDE	522-48-5	TETRAHYDROZOLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1052943	tetrahydrozoline HCl 0.05 % Ophthalmic Solution	PSN	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8	2
1052943	tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution	SCD	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8	2
1052943	tetrahydrozoline hydrochloride 0.05 % Eye Drops	SY	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8	2
1052943	tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution	SY	23cf4227-bbc6-43cc-ae2c-3396e2b0b0f8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68016-448-00	68016044800	1 in 1 BOX	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Premier Value Original - Chain Drug Consortium, LLC	Chain Drug Consortium, LLC	2015-01-05	HUMAN OTC DRUG LABEL	2