FDA.reportPublic FDA data

NIGHTTIME COLD AND FLU

Product NDC
41226-694
11-digit product format
412260694
Labeler code
41226
Product ID
41226-694_2dc8828e-abd9-8993-e063-6294a90afc8c
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE
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; ACETAMINOPHEN; DOXYLAMINE SUCCINATE
Active strength
15; 325; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
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 packagepackage41226-694-24302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41226-694-24ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41226-694-240efc9e666f02…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
NIGHTTIME COLD AND FLU
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
ACETAMINOPHEN325 mg/1
DOXYLAMINE SUCCINATE6.25 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
362O9ITL9DInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094549Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc0115a3-5322-855d-e053-2995a90aba27Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41226-694-242025-02-10C16284748780-12cef2736-652c-d83d-e063-dadaa90ab31f694T KROGER 41226 694 Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate CT 24
41226-694-242025-01-30C16284748780-12cef2736-652c-d83d-e063-dadaa90ab31f694T KROGER 41226 694 Acetaminophen Dextromethorphan Hydrobromide Doxylamine Succinate CT 24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-694-24NIGHTTIME COLD AND FLU2 in 1 CARTONCAPSULE, LIQUID FILLED24
41226-694-24NIGHTTIME COLD AND FLU12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-694NIGHTTIME COLD AND FLU (DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [KROGER COMPANY]4Current NDC, Legacy NDC, 2 package rows20250212_bc0115a3-5322-855d-e053-2995a90aba27.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 168 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLCf5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb2024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC62f7fcb9-e31a-4634-b1c2-44a9567e3a612024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu CapletsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC8e22f6bc-33ce-4bb0-99be-7947aa21f60e2024-03-07WarningsExact identifier
application number: M012
Theraflu ExpressMax Severe Cold and Flu SyrupACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHaleon US Holdings LLC777d2ac7-e3cc-4513-8b6f-b90b2ff2c6722024-03-07WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCVS Pharmacy4c6025ff-4982-4408-b077-75dd5f5b65b22024-03-07WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS Pharmacy423fd5e6-5d90-4539-81e0-0ae23881ee3a2024-03-07WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy917df706-1982-4240-9f56-42d426b76cc52024-03-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)21a29998-29d6-4a36-a370-291d23bfb1972024-03-05WarningsExact identifier
application number: M012
Multi-Symptom Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCare One (Retail Business Services, LLC.)3c7ef3cf-f7f9-42bc-bf20-e36954b9671f2024-03-05WarningsExact identifier
application number: M012
QUALITY CHOICE NightTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.da06e994-6848-4c1e-9432-31de5e626ea42024-03-02WarningsExact identifier
application number: M012
QUALITY CHOICE DayTime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Association, Inc.417c4fa9-6458-40d0-b22a-2415194e250f2024-03-02WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAurohealth LLC8eaa0eec-cc52-4f1f-8ddb-06c54d577ce22024-03-01WarningsExact identifier
application number: M012
APRODINEPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLA-S Medication Solutionsbbc268b8-fa66-4dc5-b935-f77ae39d28c82024-02-29WarningsExact identifier
application number: M012
XtraCare Vaporizing Chest RubCAMPHOR, MENTHOLRejoice Internationalc3e220d6-fff4-452f-99a9-bd701fc608a02024-02-28WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime Berry BurstACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCebbb2f4b-ba84-40ad-96f6-60225119a33b2024-02-27WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMERISOURCE BERGEN1c93c45d-1141-4599-83ba-6d3b38f9ffc42024-02-23WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAmeriSource Bergen3dc293c9-736b-4bd8-b993-ff83b9909bcd2024-02-23WarningsExact identifier
application number: M012
Childrens Dibromm Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLCardinal Health (Leader) 7000010cc7d67-30c4-4451-bf74-78abae3c8e252024-02-23WarningsExact identifier
application number: M012
Nasal Spray, 24-7 for LifeOXYMETAZOLINE HYDROCHLORIDE 0.05%Lil' Drug Store Products, Inc.11d27c75-fd95-f9da-e063-6394a90ac6b02024-02-20WarningsExact identifier
application number: M012
Nighttime Cold and Cough childrensDIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)11652e8a-2242-4449-8a41-a8e75509025e2024-02-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNbc0115a3-5322-855d-e053-2995a90aba274
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDbc0115a3-5322-855d-e053-2995a90aba274
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYbc0115a3-5322-855d-e053-2995a90aba274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-694-24412260694242 BLISTER PACK in 1 CARTON (41226-694-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2021-05-110000-00-00NoNoCurrent