FDA.reportPublic FDA data

Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz

Product NDC
67751-217
11-digit product format
677510217
Labeler code
67751
Product ID
67751-217_2395eed2-0bab-a839-e063-6394a90aded6
Type
HUMAN OTC DRUG
Nonproprietary name
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Navajo Manufacturing Company Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10; 2; 5; 250 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
CHLORPHENIRAMINE MALEATE2 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
V1Q0O9OJ9ZInternal UNII lookup
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1536477Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6068011-ad56-59b4-e053-2995a90ac016Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-217-01Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 CARTONTABLET, EFFERVESCENT12
67751-217-01Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 POUCHTABLET, EFFERVESCENT12
67751-217-02Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz2 in 1 POUCHTABLET, EFFERVESCENT22
67751-217-02Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz1 in 1 CARTONTABLET, EFFERVESCENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-217ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ (CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, EFFERVESCENT [NAVAJO MANUFACTURING COMPANY INC.]2Current NDC, 4 package rows20241004_f6068011-ad56-59b4-e053-2995a90ac016.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 151 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough DropsMENTHOLUnited Natural Foods, Inc.f9f0d020-e031-245e-e053-6294a90addb52024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7ee463-8003-a306-e053-6294a90a82592024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7e4a84-d2c2-65e5-e053-6394a90a0c722024-10-08WarningsExact identifier
application number: M012
Cough DropsCHERRYUnited Natural Foods, Inc.f9f0e853-6997-a49b-e053-6294a90aa4b82024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7fa728-911d-aaf0-e053-6394a90ace312024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f3b84-1e61-eadf-e053-6394a90a9e5c2024-10-08WarningsExact identifier
application number: M012
Cough DropsMENTHOLUnited Natural Foods, Inc.fb7f515f-7302-d153-e053-6394a90a08342024-10-08WarningsExact identifier
application number: M012
Rompe Pecho NT NTACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEEfficient Laboratories Inc06faafaa-50a6-c16e-e063-6294a90a49cb2024-10-08WarningsExact identifier
application number: M012
Mucus Relief Cough and Congestion DMGUAIFENESIN AND DEXTROMETHORPHAN HBRBryant Ranch Prepack8c25285e-e2cd-4e10-af63-5dce8098b6152024-10-08WarningsExact identifier
application number: M012
Severe Throat Sore DropsMENTHOLTarget Corporation Inc.949543d5-5043-ac06-e053-2995a90ab3982024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsCOUGH DROPSTarget Corporation Inc.a23ddfa9-19e0-99ee-e053-2a95a90a68562024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY MENTHOL COUGH DROPSPerrigo Direct, Inc.fb809c63-94f1-bb7a-e053-6294a90a0a392024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY CHERRY COUGH DROPSPerrigo Direct, Inc.fb808dc5-bf63-836c-e053-6294a90a80aa2024-10-07WarningsExact identifier
application number: M012
Cough DropsSIMPLY HONEY LEMONPerrigo Direct Inc.fb898616-d604-b4c3-e053-6294a90a23bf2024-10-07WarningsExact identifier
application number: M012
Natural Herb Cough DropsMENTHOL HERBCVS Pharmacyfcd16063-abca-49a0-e053-6294a90acb262024-10-07WarningsExact identifier
application number: M012
Lemon Mint Herb Throat DropsSUGAR FREE LEMON MINT HERBCVS Pharmacyfce6b5fa-846d-9911-e053-6294a90afc9b2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCVS Pharmacyfcd053e9-92ef-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyf074a64d-dc01-1a37-e053-2995a90adc492024-10-07WarningsExact identifier
application number: M012
Cough DropsHONEY LEMONCVS Pharmacyf075010d-a07a-5e9d-e053-2995a90a3ca32024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsHONEY LEMONCVS Pharmacyfcd053e9-92ee-70ba-e053-6294a90aa4dd2024-10-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Effervescent Oral TabletPSNf6068011-ad56-59b4-e053-2995a90ac0162
1536477acetaminophen 250 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Effervescent Oral TabletSCDf6068011-ad56-59b4-e053-2995a90ac0162
1536477APAP 250 MG / Chlorpheniramine Maleate 2 MG / Dextromethorphan Hydrobromide 10 MG / Phenylephrine Hydrochloride 5 MG Effervescent Oral TabletSYf6068011-ad56-59b4-e053-2995a90ac0162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67751-217-01677510217011 POUCH in 1 CARTON (67751-217-01) / 1 TABLET, EFFERVESCENT in 1 POUCH1 pouch2022-06-01NoNoCurrent
67751-217-02677510217021 POUCH in 1 CARTON (67751-217-02) / 2 TABLET, EFFERVESCENT in 1 POUCH1 pouch2022-06-01NoNoCurrent