FDA.reportPublic FDA data

DAYTIME COLD AND FLU

Product NDC
41226-693
11-digit product format
412260693
Labeler code
41226
Product ID
41226-693_2dd90dc8-6a53-083c-e063-6394a90ad569
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kroger Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-11
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
10; 5; 325 mg/1; mg/1; mg/1
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41226-693-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-693-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-693-240efc9e666f02…f202fb6c5f17…

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
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal 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
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc00bbf8-52bb-fa75-e053-2a95a90a9406Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41226-693-242025-02-11C16284748780-12cef2736-8085-d83d-e063-dadaa90ab31f693T KROGER 41226 693 Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride CT 24
41226-693-242025-01-30C16284748780-12cef2736-8085-d83d-e063-dadaa90ab31f693T KROGER 41226 693 Acetaminophen Dextromethorphan Hydrobromide Phenylephrine Hydrochloride CT 24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-693-24DAYTIME COLD AND FLU12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124
41226-693-24DAYTIME COLD AND FLU2 in 1 CARTONCAPSULE, LIQUID FILLED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-693DAYTIME COLD AND FLU (DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20250213_bc00bbf8-52bb-fa75-e053-2a95a90a9406.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 160 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dg health allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, LLC71445443-34bd-4d8c-b9c8-e7c3b8d4c8322024-07-19WarningsExact identifier
application number: M012
basic care childrens allergy reliefDIPHENHYDRAMINE HCLAmazon.com Services LLC75b9ee90-ad26-433e-8b90-97441b8d1e152024-07-19WarningsExact identifier
application number: M012
Cold and Flu Severe Day and NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC9b74dd00-8f84-4fce-b5ea-df886b5953262024-07-18WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.4872dfdd-0df6-47ae-87f2-8049191cd4822024-07-18WarningsExact identifier
application number: M012
equate allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWal-Mart Stores Incb05acd16-21cb-4ee0-afa0-8f7d591664352024-07-18WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLPublix Super Markets Inccc6e4e26-84f5-4003-b1eb-f0e06d3e294e2024-07-18WarningsExact identifier
application number: M012
childrens allergyDIPHENHYDRAMINE HYDROCHLORIDEKroger Company10ebc7f8-dc8a-4640-8f87-d0d073998fd52024-07-18WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEAmerisource Bergenb173cc2c-7c4c-4f9e-a920-c71bc256ec1e2024-07-18WarningsExact identifier
application number: M012
ALLERGYCHLORPHENIRAMINE MALEATEA-S Medication Solutionsb199b5ee-fff3-4746-be68-a04060586f8e2024-07-18WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HCLH E B2d1715b3-b1cf-455d-9909-f6d58c97db402024-07-18WarningsExact identifier
application number: M012
careone allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmerican Sales Companyed4038fc-ab39-4567-9961-2b390b91b1262024-07-17WarningsExact identifier
application number: M012
Topcare childrens allergyDIPHENHYDRAMINE HYDROCHLORIDETopco Associates LLC6b784cde-3152-4421-a825-dd1fc601aa7a2024-07-17WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreens4c6b6379-3a7f-4507-a792-7b69a7f3ba822024-07-17WarningsExact identifier
application number: M012
Mucus Relief Cold Flu Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens04defcf6-e20e-402b-b725-d9394a0146b12024-07-16WarningsExact identifier
application number: M012
basic care allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEAmazon.com Services LLC7d237d37-21c7-476d-a8b7-d91ea1b472ee2024-07-16WarningsExact identifier
application number: M012
Berkley and Jensen Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWCb52fc311-8853-4116-941b-8be35456abba2024-07-16WarningsExact identifier
application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCLWalgreens0b9a4438-7d13-484c-a614-2dedc24974dc2024-07-16WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HYDROCHLORIDEPublix Super Markets Inc23a98385-28cc-4fac-8c87-b3ced81065322024-07-16WarningsExact identifier
application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe0.05% OXYMETAZOLINEWalgreens Companyaad01028-cbe0-4c10-adbc-d157bfa5af092024-07-16WarningsExact identifier
application number: M012
Basic Care severe cold and coughACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC924bf427-b054-46af-b341-ff162946cd582024-07-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNbc00bbf8-52bb-fa75-e053-2a95a90a94064
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDbc00bbf8-52bb-fa75-e053-2a95a90a94064
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYbc00bbf8-52bb-fa75-e053-2a95a90a94064

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-693-24412260693242 BLISTER PACK in 1 CARTON (41226-693-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-05-110000-00-00NoNoCurrent