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 92 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Dye Free Childrens Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDETarget Corporation76299495-7259-4bbe-8393-7eabfe22715a2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENS DT AND NT COLD and COUGHBROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,PHENYLEPHRINE HCL,DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLTARGET CORPORATION05ac2a40-5eee-4013-b55b-6e370a28b21c2025-11-05WarningsExact identifier
application number: M012
TARGET CHILDRENs COLD and COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATIONeb912834-1b14-484d-90f7-a8deb52c0d4e2025-11-05WarningsExact identifier
application number: M012
UP and UP Daytime Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationa2d99bc8-7295-4922-acff-0cb02c91273c2025-11-05WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILAMERISOURCE BERGENc1843f1a-ae5b-0fdf-e053-2995a90aae382025-11-05WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4754363d-e163-42e0-a65d-1c4bac24f6c92025-11-05WarningsExact identifier
application number: M012
Day Time Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLSafeway, Inc.76d62892-615d-4744-95aa-3be1207a0e572025-11-05WarningsExact identifier
application number: M012
Tussin DM Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.6fefff08-13b0-47eb-aa32-8d7e4deeae7b2025-11-05WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Eucalyptus 30ctMENTHOLR.L. ALBERT & SON, INC165a8efa-2b03-4329-99fa-3233f0af7d082025-11-04WarningsExact identifier
application number: M012
Menthol Drops Freegells Extra Strong Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INCf9ea46fc-0b04-444e-95fc-09aff7e7978a2025-11-04WarningsExact identifier
application number: M012
QUALITY CHOICE Maximum Strength Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.40413cdb-68ac-70e1-e063-6394a90a92172025-11-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC73fec783-1594-447b-b059-49ea9dbb5bee2025-11-04WarningsExact identifier
application number: M012
Texaclear Fast Acting Allergy ReliefCHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATEGM Pharmaceuticals, INC17a2f643-fa98-21ee-e054-00144ff88e882025-11-03WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e618bc7-0f51-e586-e063-6294a90afe372025-11-03WarningsExact identifier
application number: M012
Head Congestion plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e61b5b3-ad15-01bf-e063-6394a90a6ec32025-11-03WarningsExact identifier
application number: M012
Cold plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC409540c0-1bab-9969-e063-6394a90a47c12025-11-03WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60b340-bd60-9318-e063-6294a90ad0792025-11-03WarningsExact identifier
application number: M012
Sinus Pressure and Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e60e32f-3e5f-b775-e063-6294a90a097d2025-11-03WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEHYVEE INC3e614265-b35a-5d01-e063-6294a90aad852025-11-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60b0ed-889d-0f17-e063-6394a90a46942025-11-03WarningsExact 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