FDA.reportPublic FDA data

Daytime Nighttime Cold Flu Relief

Product NDC
69842-896
11-digit product format
698420896
Labeler code
69842
Product ID
69842-896_46775ab8-8b5a-477f-81d7-819cae41dcee
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form
KIT
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-31
Marketing end
2027-11-28
NDC exclude flag
No
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 Nighttime Cold Flu Relief

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1094549Internal RxNorm lookup
1426334Internal RxNorm lookup
2634564Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
df6e522c-3e30-4aa0-8ab9-3b579c80bcadAvailable 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, Related label table
NDCEffectiveRelated label
69842-896-242020-10-22Drug Facts
69842-896-242020-10-22Drug Facts
69842-896-242020-10-22Drug Facts
69842-896-242020-10-22Drug Facts
69842-896-482020-10-22Drug Facts
69842-896-482020-10-22Drug Facts
69842-896-482020-10-22Drug Facts
69842-896-482020-10-22Drug Facts
69842-896-242020-09-27Drug Facts
69842-896-242020-09-27Drug Facts
69842-896-242020-09-27Drug Facts
69842-896-242020-09-27Drug Facts
69842-896-482020-09-27Drug Facts
69842-896-482020-09-27Drug Facts
69842-896-482020-09-27Drug Facts
69842-896-482020-09-27Drug Facts
69842-896-242020-09-25Drug Facts
69842-896-242020-09-25Drug Facts
69842-896-242020-09-25Drug Facts
69842-896-242020-09-25Drug Facts
69842-896-482020-09-25Drug Facts
69842-896-482020-09-25Drug Facts
69842-896-482020-09-25Drug Facts
69842-896-482020-09-25Drug Facts
69842-896-242020-07-22Drug Facts
69842-896-242020-07-22Drug Facts
69842-896-242020-07-22Drug Facts
69842-896-242020-07-22Drug Facts
69842-896-482020-07-22Drug Facts
69842-896-482020-07-22Drug Facts
69842-896-482020-07-22Drug Facts
69842-896-482020-07-22Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-896-24Daytime Nighttime Cold Flu Relief1 in 1 KITKIT19
69842-896-48Daytime Nighttime Cold Flu Relief1 in 1 KITKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-896-24EA - Each69842-89635176892-183c-44ac-a949-7abe23dcf01f12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-896DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [CVS PHARMACY]5Current NDC, Legacy NDC, 2 package rows20250516_df6e522c-3e30-4aa0-8ab9-3b579c80bcad.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 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Effervescent Cold Relief OrangeASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEFamily Dollar Services, Inc.4e13511b-fbb5-2523-e054-00144ff88e882024-07-03WarningsExact identifier
application number: M012
Nighttime Cherry Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATETARGET CORPORATION1c3f6cbf-a00d-45b9-e063-6394a90a797c2024-07-02WarningsExact identifier
application number: M012
Cold Terminator Cold ReliefPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWildman Business Groupe8538d9c-f9ba-40b1-b60f-f57921f39b642024-07-01WarningsExact identifier
application number: M012
Nighttime Severe Honey Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION1c02e465-8750-a088-e063-6394a90a8efb2024-06-29WarningsExact identifier
application number: M012
ACTIDOM DMXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLC0166322e-7dbb-4658-a5c5-1d0525bb76552024-06-28WarningsExact identifier
application number: M012
ACTINEL DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLACTIPHARMA, LLC16660d82-524b-42ca-8581-48237caa13b22024-06-28WarningsExact identifier
application number: M012
PurgenLabs AcetaminophenACTAMINOPHENAdvanced Rx LLC915c4608-af1b-4119-8291-4ce9fd701d762024-06-28WarningsExact identifier
application number: M012
Daytime Ultra Concentrated Cold and FluACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCLTARGET CORPORATION1bc90b2f-612c-e977-e063-6294a90a40b42024-06-26WarningsExact identifier
application number: M012
Halls MentholyptusMENTHOLMondelez Global LLCf5292c5b-5608-4e13-afc2-4f3d7133da882024-06-25WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLC75638f29-7f2a-46b0-b8a0-e87bc7d6eba12024-06-25WarningsExact identifier
application number: M012
Good Sense Nasal Decongestant PEPHENYLEPHRINE HYDROCHLORIDEA-S Medication Solutions5396a9cf-16eb-4628-9432-f49c67ffe2ce2024-06-25WarningsExact identifier
application number: M012
Nighttime Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATETARGET CORPORATION130ca5f1-2951-ec6f-e063-6394a90a754f2024-06-24WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATETARGET CORPORATION08fd1513-30ab-15da-e063-6394a90ab57d2024-06-21WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORPORATION0c0caa59-0637-bc33-e063-6294a90ae2442024-06-21WarningsExact identifier
application number: M012
Halls StrawberryMENTHOLMondelez Global LLCde401eb4-3282-4298-8a51-15d2682534642024-06-21WarningsExact identifier
application number: M012
Cough and Chest Congestion DM Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINWalgreense4515d0e-c12b-40cd-8218-6d91476cfebd2024-06-21WarningsExact identifier
application number: M012
SUDOGESTPSEUDOEPHEDRINE HCLA-S Medication Solutions1811199f-bf88-475f-8f94-b372db4bead32024-06-20WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Soft ChewsACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC91dbb541-6a86-4803-a1fe-1bf61b457c342024-06-19WarningsExact identifier
application number: M012
Tukol Max Action Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USAaedce1f9-4902-4c51-92e0-6056196394c22024-06-14WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIdbc71f58-0704-4d2b-aed1-0dc01f9800062024-06-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSNdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSYdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYdf6e522c-3e30-4aa0-8ab9-3b579c80bcad9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-896-24698420896241 KIT in 1 KIT (69842-896-24) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK1 kit2019-07-312027-11-28NoNoCurrent
69842-896-48698420896481 KIT in 1 KIT (69842-896-48) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 8 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK1 kit2019-07-312027-11-28NoNoCurrent