FDA.reportPublic FDA data

DRISTAN 12 HR

Product NDC
0573-1191
Requested package NDC
0573-1191-20
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-11910573-1191-20DDiscontinued by firm2026-08-17

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-1191-202023-06-12C16284748780-1f386c649-e774-0266-e053-dadaa90a7c1aDrug Facts
0573-1191-202023-01-30C16284748780-1f386c649-e774-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-1191-20ML - Milliliter0573-1191485b8d05-151d-4e7c-8e07-6cc6ff671f3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYMETAZOLINE HYDROCHLORIDEACTIVE INGREDIENTK89MJ0S5VYDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
OXYMETAZOLINEACTIVE MOIETY8VLN5B44ZYDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74DRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4
WATERINACTIVE INGREDIENT059QF0KO0RDRISTAN 12 HR (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [PFIZER CONSUMER HEALTHCARE]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0573-1191-20005731191201 BOTTLE, SPRAY in 1 CARTON (0573-1191-20) > 15 mL in 1 BOTTLE, SPRAY2004-01-012021-06-22NoNoCurrent