FDA.reportPublic FDA data

Afrin No Drip Night

Product NDC
11523-1160
11-digit product format
115231160
Labeler code
11523
Product ID
11523-1160_eaffe27a-6d27-5602-e053-2a95a90a5b06
Type
HUMAN OTC DRUG
Nonproprietary name
oxymetazoline hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Bayer HealthCare LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-07-01
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-1160IInactivated by FDA2026-08-11
excluded packagepackage11523-116011523-1160-1DDiscontinued by firm2026-08-11
excluded packagepackage11523-116011523-1160-2IInactivated by FDA2026-08-11

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 · 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…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-1160-12026-01-29C16284748780-149896155-c7e1-586f-e063-e6dba90add90Afrin No Drip Night Pump Mist UI 1612461
11523-1160-22026-01-29C16284748780-149896155-c7e1-586f-e063-e6dba90add90Afrin No Drip Night Pump Mist UI 1612461

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1160-1Afrin No Drip NightChamomile0.5 mL in 1 BOTTLE, PUMPSPRAY, METERED0.57
11523-1160-2Afrin No Drip NightChamomile15 mL in 1 BOTTLE, PUMPSPRAY, METERED157
11523-1160-2Afrin No Drip NightChamomile1 in 1 CARTONSPRAY, METERED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1160AFRIN NO DRIP NIGHT CHAMOMILE (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [BAYER HEALTHCARE LLC.]7Legacy NDC, 3 package rows20241208_a3f997c2-d6b5-d9d5-e053-2995a90a6f26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSNa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBDa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000992Afrin 0.05 % Nasal SpraySYa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000992Afrin 0.5 MG/ML Nasal SpraySYa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYa3f997c2-d6b5-d9d5-e053-2995a90a6f267
1000992Afrin 0.05 % Nasal SprayPSN16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline HCl 0.05 % Nasal SprayPSN16c52c79-baec-87db-e063-6294a90a3b3b2
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBD16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCD16c52c79-baec-87db-e063-6294a90a3b3b2
1000992Afrin 0.05 % Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2
1000992Afrin 0.5 MG/ML Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySY16c52c79-baec-87db-e063-6294a90a3b3b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-1160-1115231160010.5 mL in 1 BOTTLE, PUMP0.5 mlHistorical
11523-1160-2115231160021 BOTTLE, PUMP in 1 CARTON (11523-1160-2) > 15 mL in 1 BOTTLE, PUMP2020-07-010000-00-00NoNoCurrent