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 77 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLSALADO SALES INC.8f66f5bc-7c77-420b-9feb-911c980fbfdc2025-12-12WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.de55a9fd-53a2-4f3e-82b7-cabcbe287d462025-12-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESALADO SALES INC.cc73b668-cc6a-41d6-800a-4988c59c04492025-12-12WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC75269bcc-3bb2-49a0-8788-6b7da18796d32025-12-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus plus AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEaffac07f-d645-4999-98ee-7467902f5adc2025-12-12WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp8fd0071b-c6ca-49e6-b159-45dead71b6642025-12-11WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp098582dc-3e12-782f-e063-6394a90aa1a12025-12-11WarningsExact identifier
application number: M012
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY2e751d67-51b4-4b74-a9e8-7f3bc56369842025-12-11WarningsExact identifier
application number: M012
Pressure and Pain Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY232acb86-7383-4992-b333-1e47bf7c06ad2025-12-11WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY72847721-9f59-4af1-8f20-dc84497429182025-12-11WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401317-0295-14b3-e053-2a95a90acbb42025-12-11WarningsExact identifier
application number: M012
Head Congestion plus Flu Severe PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401b58-8cf8-4067-e053-2995a90a68fc2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYb1ba37b8-4558-0808-e053-2995a90a9f5e2025-12-11WarningsExact 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