FDA.reportPublic FDA data

Afrin Original Nasal

Product NDC
11523-1168
Requested package NDC
11523-1168-6
11-digit product format
115231168
Labeler code
11523
Product ID
11523-1168_af46c635-d3ab-99eb-e053-2995a90ae906
Type
HUMAN OTC DRUG
Nonproprietary name
OXYMETAZOLINE HYDROCHLORIDE
Dosage form
LIQUID
Route
NASAL
Labeler
Bayer HealthCare LLC.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 · 4 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-1168-62023-02-03C16284748780-1c7ccaba7-110d-fd44-e053-dadaa90aa01bAfrin Original Nasal Spray
11523-1168-62021-07-23C16284748780-1c7ccaba7-110d-fd44-e053-dadaa90aa01bAfrin Original Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-1168-6Afrin Original Nasal6 mL in 1 BOTTLESPRAY63
11523-1168-6Afrin Original Nasal6 in 1 BOXSPRAY63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-1168AFRIN ORIGINAL NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [BAYER HEALTHCARE LLC.]3Legacy NDC, 2 package rows20231106_af46c67d-f01f-83f8-e053-2a95a90aa70f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000992Afrin 0.05 % Nasal SprayPSNaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline HCl 0.05 % Nasal SprayPSNaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992oxymetazoline hydrochloride 0.5 MG/ML Nasal Spray [Afrin]SBDaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline hydrochloride 0.5 MG/ML Nasal SpraySCDaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992Afrin 0.05 % Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000992Afrin 0.5 MG/ML Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3
1000990oxymetazoline hydrochloride 0.05 % Nasal SpraySYaf46c67d-f01f-83f8-e053-2a95a90aa70f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-1168-6115231168066 BOTTLE in 1 BOX (11523-1168-6) > 6 mL in 1 BOTTLE6 bottle2020-10-010000-00-00NoNoCurrent