DRISTAN 12 HR

Product NDC: 0573-1191
11-digit product format: 005731191
Labeler code: 0573
Product ID: 0573-1191_267c4196-ee61-4c44-995c-86d1aaf24679
Type: HUMAN OTC DRUG
Nonproprietary name: oxymetazoline hydrochloride
Dosage form: SPRAY
Route: NASAL
Labeler: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2004-01-01
Marketing end: 0000-00-00
Substance: OXYMETAZOLINE HYDROCHLORIDE
Active strength: 1 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
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	0573-1191		D	Discontinued by firm		2026-08-11
excluded package	package	0573-1191	0573-1191-20	D	Discontinued by firm		2026-08-11

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 · 24 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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`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	0573-1191-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-1191-20	2023-06-12	C162847	48780-1	f386c649-e774-0266-e053-dadaa90a7c1a	Drug Facts
0573-1191-20	2023-01-30	C162847	48780-1	f386c649-e774-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-1191-20	ML - Milliliter	0573-1191	485b8d05-151d-4e7c-8e07-6cc6ff671f3e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
OXYMETAZOLINE HYDROCHLORIDE	ACTIVE INGREDIENT	K89MJ0S5VY	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
OXYMETAZOLINE	ACTIVE MOIETY	8VLN5B44ZY	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
PHOSPHORIC ACID	INACTIVE INGREDIENT	E4GA8884NN	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K89MJ0S5VY	OXYMETAZOLINE HYDROCHLORIDE	2315-02-8	OXYMETAZOLINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0573-1191-20	00573119120	1 BOTTLE, SPRAY in 1 CARTON (0573-1191-20) > 15 mL in 1 BOTTLE, SPRAY	2004-01-01	2021-06-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	2021-06-08	HUMAN OTC DRUG LABEL	7