Mucinex Sinus-Max

Product NDC
63824-127
11-digit product format
638240127
Labeler code
63824
Product ID
63824-127_2f8a31a1-17c0-4492-83e5-bd1edc0593f2
Type
HUMAN OTC DRUG
Nonproprietary name
Oxymetazoline Hydrochloride
Dosage form
SOLUTION
Route
NASAL
Labeler
RB Health (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-09-01
Marketing end
2020-12-31
Substance
OXYMETAZOLINE HYDROCHLORIDE
Active strength
0 mg/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63824-127DDiscontinued by firm2026-10-12
excluded packagepackage63824-12763824-127-75DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63824-127-75d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63824-127-75f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63824-127-752ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63824-127-75a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63824-127-75cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63824-127-75cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63824-127-75302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63824-127-75ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63824-127-750efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63824-127-75ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63824-127-75367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63824-127-75557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63824-127-75ML - Milliliter63824-127f7f22bbf-b17d-4999-9c01-91dbb576722e12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Oxymetazoline HydrochlorideACTIVE INGREDIENTK89MJ0S5VYMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
OxymetazolineACTIVE MOIETY8VLN5B44ZYMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7MUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
eucalyptolINACTIVE INGREDIENTRV6J6604TKMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
glycineINACTIVE INGREDIENTTE7660XO1CMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
mentholINACTIVE INGREDIENTL7T10EIP3AMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1
waterINACTIVE INGREDIENT059QF0KO0RMUCINEX SINUS-MAX FULL FORCE (OXYMETAZOLINE HYDROCHLORIDE) SOLUTION [RECKITT BENCKISER LLC]1