FDA.reportPublic FDA data

Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels

Product NDC
0280-0095
11-digit product format
002800095
Labeler code
0280
Product ID
0280-0095_47e31806-7f5d-9a08-e063-6394a90ab71f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan hydrobromide , Phenylephrine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Rxcui1086997

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-0095-01Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels2 in 1 CARTONCAPSULE, LIQUID FILLED29
0280-0095-01Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED89
0280-0095-02Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED129
0280-0095-02Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels2 in 1 CARTONCAPSULE, LIQUID FILLED29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-0095ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS, CONGESTION AND PAIN POWER MAX GELS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 4 package rows20240821_e07931fc-f753-1aeb-e053-2a95a90ada3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634363{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKf6c73f61-f4fc-377f-e053-6294a90a379711
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackPSNf6c73f61-f4fc-377f-e053-6294a90a379711
1297288acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral CapsulePSNf6c73f61-f4fc-377f-e053-6294a90a379711
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNf6c73f61-f4fc-377f-e053-6294a90a379711
1297288acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf6c73f61-f4fc-377f-e053-6294a90a379711
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf6c73f61-f4fc-377f-e053-6294a90a379711
26343631 daytime (acetaminophen 325 MG / dextromethorphan Hbr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule) PackSYf6c73f61-f4fc-377f-e053-6294a90a379711
1297288APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral CapsuleSYf6c73f61-f4fc-377f-e053-6294a90a379711
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYf6c73f61-f4fc-377f-e053-6294a90a379711
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNe07931fc-f753-1aeb-e053-2a95a90ada3f9
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDe07931fc-f753-1aeb-e053-2a95a90ada3f9
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYe07931fc-f753-1aeb-e053-2a95a90ada3f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-0095-01002800095012 BLISTER PACK in 1 CARTON (0280-0095-01) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-08-250000-00-00NoNoCurrent
0280-0095-02002800095022 BLISTER PACK in 1 CARTON (0280-0095-02) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-08-250000-00-00NoNoCurrent