FDA.reportPublic FDA data

Theraflu Severe Cold Relief Daytime

Product NDC
85237-1896
11-digit product format
852371896
Labeler code
85237
Product ID
85237-1896_55fc88c7-8e44-f123-e063-6294a90adcfd
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HBr
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Select Consumer Group
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
500; 20 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
Theraflu Severe Cold Relief Daytime
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE20 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
2670598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
55fc7d6f-cc44-b4c0-e063-6294a90ae4fcAvailable 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 164 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafeway, Inc.a70ead03-6d2c-44c1-9ae5-f6c4094821ec2024-05-14WarningsExact identifier
application number: M012
Day Time Cold and Flu Relief non drowsyACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.cc450f89-a156-48e0-82ae-19782f13c2ca2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLSafeway, Inc.a8df5c04-0f92-4013-b3e5-2b45009a7b8d2024-05-13WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCI DOXYLAMINESUCINATESafeway, Inc.f762600a-f4b1-4869-a04b-8431c3d8a3e32024-05-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.ef0cd436-5e81-47a7-92d6-58495283ab282024-05-13WarningsExact identifier
application number: M012
Tussin Cough Sugar FreeDEXTROMETHORPHAN HBR GUAIFENESINP & L Development, LLC7ed2fe86-3346-4308-a9b6-6a264f879b022024-05-09WarningsExact identifier
application number: M012
Severe Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANY10106c90-f2f0-508e-e063-6294a90a544b2024-05-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATEKroger1013ce02-7b12-335e-e063-6394a90af3e62024-05-08WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATEKroger10b08ea8-693e-eb18-e063-6394a90af5482024-05-08WarningsExact identifier
application number: M012
Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b0bcff-d3bc-f70c-e063-6394a90a35ed2024-05-08WarningsExact identifier
application number: M012
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger10b0e0a0-b878-0a9a-e063-6394a90a20e02024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime HoneyACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger10b0fa3d-d6b2-272a-e063-6394a90a12052024-05-08WarningsExact identifier
application number: M012
Childrens Plus Multi Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWalgreensdd967cfb-96b4-4cdc-82e2-a4838001c9e32024-05-08WarningsExact identifier
application number: M012
Childrens Wal Tap Elixer Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreens3f438f28-d1ad-44da-a573-f1b0824b051c2024-05-08WarningsExact identifier
application number: M012
Cough Cold and Sore Throat ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens400a0998-e276-4c8d-9b41-145b1b405fff2024-05-08WarningsExact identifier
application number: M012
Mucus Congestion and Cough Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCIWalgreens19cd2409-d56b-4319-833c-eacc7dc498c12024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b12f0e-dba7-fd71-e063-6294a90a42c12024-05-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATEKroger10b15337-b9c5-4dc8-e063-6394a90ac0562024-05-06WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger1014da86-3a0e-136f-e063-6294a90ac9312024-05-04WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85237-1896-1852371896011 PACKET in 1 BLISTER PACK (85237-1896-1) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0) 1 packet2023-12-01NoNoCurrent
85237-1896-38523718960320 PACKET in 1 CARTON (85237-1896-3) / 1 POWDER, FOR SOLUTION in 1 PACKET (85237-1896-0) 20 packet2023-12-01NoNoCurrent