FDA.reportPublic FDA data

Daytime Cold and Flu

Product NDC
41226-772
11-digit product format
412260772
Labeler code
41226
Product ID
41226-772_17a11a32-9854-df2f-e063-6294a90a7770
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Kroger
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-30
Substance
PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength
5; 10; 325 mg/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
Daytime Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
ACETAMINOPHEN325 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
9D2RTI9KYHInternal 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
1113705Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014da86-3a0e-136f-e063-6294a90ac931Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-772-01Daytime Cold and Flu354 mL in 1 BOTTLELIQUID3543
41226-772-01Daytime NighttimeCold and Flu354 mL in 1 BOTTLELIQUID354 mL5 mg in 15mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-772DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [KROGER]3Current NDC, 1 package rows20240509_1014da86-3a0e-136f-e063-6294a90ac931.zip
41226-772DAYTIME NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE) KIT [KROGER]2Current NDC20240518_10b15337-b9c5-4dc8-e063-6394a90ac056.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 14 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLOPHEDIANOL HCL, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLGil Pharmaceutical Corp85a0dc7f-ffb5-7d52-e053-2991aa0a602a2026-07-23WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8590fcc9-c0dd-f43b-e053-2991aa0a692e2026-07-23WarningsExact identifier
application number: M012
Giltuss Sinus and Chest CongestionGUAIFENESIN, PHENYLEPHRINE HCLGil Pharmaceutical Corp8591003c-c2f2-df65-e053-2a91aa0a42fb2026-07-23WarningsExact identifier
application number: M012
COLDTAC PlusACETAMINOPHEN, PHENYLEPHRIN HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEOPMX LLC3496866c-682f-420b-bfdb-64ecebbf70a22026-07-23WarningsExact identifier
application number: M012
nighttime cough dmDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.5a45b4c2-6a15-40b4-9ac6-d1554244ec422026-07-23WarningsExact identifier
application number: M012
DAY TIME NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.6372cbdd-a3a3-499d-91ce-53bcdb83e7392026-07-23WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacydf6e522c-3e30-4aa0-8ab9-3b579c80bcad2026-07-22WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ab2ba6a-1fac-4a34-ab76-0b50b425d0ba2026-07-22WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEKenvue Brands LLC1c5386c1-e45d-9dcb-e063-6294a90aff072026-07-22WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp772d0184-8c41-40f1-bbef-7e68692eec662026-07-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN1014da86-3a0e-136f-e063-6294a90ac9313
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD1014da86-3a0e-136f-e063-6294a90ac9313
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY1014da86-3a0e-136f-e063-6294a90ac9313
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY1014da86-3a0e-136f-e063-6294a90ac9313
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY1014da86-3a0e-136f-e063-6294a90ac9313
2637726{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } PackGPCK10b15337-b9c5-4dc8-e063-6394a90ac0562
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) PackPSN10b15337-b9c5-4dc8-e063-6394a90ac0562
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSN10b15337-b9c5-4dc8-e063-6394a90ac0562
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN10b15337-b9c5-4dc8-e063-6394a90ac0562
1113705acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD10b15337-b9c5-4dc8-e063-6394a90ac0562
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD10b15337-b9c5-4dc8-e063-6394a90ac0562
26377261 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) PackSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1113705acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1113705acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1113705APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY10b15337-b9c5-4dc8-e063-6394a90ac0562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41226-772-0141226077201354 mL in 1 BOTTLE (41226-772-01) 354 ml2024-04-30NoNoCurrent