daytime cold and flu

Product NDC
72288-710
11-digit product format
722880710
Labeler code
72288
Product ID
72288-710_9d7c656e-113c-4c2c-8ed7-cf2928e09f10
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-27
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
daytime cold and flu
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2709673Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6de619d3-0ab0-43e7-8dac-7bbd5368ac65Available on FDA.report

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 82 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a6a2dd4a-a3c8-2dfa-e053-2995a90ada862025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.bd49121c-7cba-c51f-e053-2995a90a921e2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare, LLC.a6b8dc25-0fb9-1823-e053-2a95a90adf932025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.c2232241-6e57-1427-e053-2995a90a488a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max GelsACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dec468-fbb2-3489-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.d7711cd6-5058-548d-e053-2a95a90ac54d2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.a2f0285b-8550-fd26-e053-2995a90ab6152025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.f6c73f61-f4fc-377f-e053-6294a90a37972025-12-04WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast FizzDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBayer Healthcare LLC.a32e2a5e-9aa0-4e7c-e053-2995a90a31902025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e2877488-3539-cba2-e053-2995a90a60052025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChewsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.14951faa-9476-6f29-e063-6394a90a14c72025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid GelsALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTIONBayer HealthCare LLC.0c120569-622d-3a23-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChewsCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.149330be-24bd-b4a4-e063-6394a90a90072025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESINBayer HealthCare LLC.5278a128-41ec-4494-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.53188c41-3f13-311b-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.75894849-a0ba-57be-e053-2a91aa0a049a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.531ab703-179a-70ad-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.7588ea67-68a9-4dc0-e053-2991aa0aa4712025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-710-627228807106212 BLISTER PACK in 1 CARTON (72288-710-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK12 blister pack2026-08-27NoNoCurrent