Mucinex Sinus-Max

Product NDC
63824-204
Requested package NDC
63824-204-20
11-digit product format
638240204
Labeler code
63824
Product ID
63824-204_106ccf9f-c27d-4700-9f86-b50abbd7ed34
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride
Dosage form
KIT
Labeler
RB Health (US) LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-06-01
Marketing end
0000-00-00
Active strength
0
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63824-20463824-204-20DDiscontinued by firm2026-10-05

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 · 11 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…

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
63824-204-40EA - Each63824-204c3243277-c3ec-4646-8de1-c5d1e0e6233b12021-09-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
GuaifenesinACTIVE INGREDIENT495W7451VQMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
AcetaminophenACTIVE MOIETY362O9ITL9DMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
DiphenhydramineACTIVE MOIETY8GTS82S83MMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
GuaifenesinACTIVE MOIETY495W7451VQMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
PhenylephrineACTIVE MOIETY1WS297W6MVMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
crospovidone (15 mpa.s at 5%)INACTIVE INGREDIENT68401960MKMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
FD&C blue no. 2INACTIVE INGREDIENTL06K8R7DQKMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOAMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
methacrylic acid - ethyl acrylate copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
micaINACTIVE INGREDIENTV8A1AW0880MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
polyvinyl alcoholINACTIVE INGREDIENT532B59J990MUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
povidone K29/32INACTIVE INGREDIENT390RMW2PEQMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
povidonesINACTIVE INGREDIENTFZ989GH94EMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMUCINEX SINUS-MAX DAY NIGHT MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RECKITT BENCKISER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63824-204MUCINEX SINUS-MAX DAY NIGHT (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) KIT [RB HEALTH (US) LLC]9Legacy NDC20230825_ae33d924-9262-41f6-964f-d8b567b3d903.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63824-204-20638240204201 KIT in 1 CARTON (63824-204-20) * 6 TABLET, COATED in 1 BLISTER PACK * 4 TABLET, COATED in 1 BLISTER PACK1 kit2015-08-250000-00-00NoNoCurrent