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 7 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINCVS PHARMACY3148f80f-8a0d-4b6c-85be-79085fc044442026-08-19WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationaa7164a7-f842-457d-abee-0740bb8c1c902026-08-19WarningsExact identifier
application number: M012
CVSCHILDRENS STUFFY NOSE AND COLDCVS PHARMACY, INC6cff265d-94a3-4617-a366-fe970d97f05a2026-08-19WarningsExact identifier
application number: M012
CVS Severe Congestion and Pain ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS5a8e4320-bae1-4831-b66b-9babfe8888d62026-08-19WarningsExact identifier
application number: M012
CVS Mucus Relief DM Maximum StrengthDEXTROMETHORPHAN HBR AND GUAIFENESINCVS PHARMACY0ae0c244-e019-4b35-890c-8e15e3d3f7ce2026-08-19WarningsExact identifier
application number: M012
CVS Severe Tussin CF MaxACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACYe32881f5-2bb5-4756-aa86-a09473ab590b2026-08-19WarningsExact identifier
application number: M012
Good Sense Tussin DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINL. Perrigo Companyd2541ef0-a73c-43aa-91ff-fdbce2748c4f2026-08-18WarningsExact identifier
application number: M012
CVS Severe Nasal Congestion Relief Clear and CoolOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.5a7e42ee-810c-4bc1-9d8d-fac8e849e1262026-08-18WarningsExact identifier
application number: M012
DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC8dd039b4-209a-484a-b15e-741d55087a932026-08-18WarningsExact identifier
application number: M012
CVS Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLCVS PHARMACY558b7ed6-a9f6-452c-90cd-df8258663bf12026-08-18WarningsExact identifier
application number: M012
Extra Strength NasalPHENYLEPHRINE HYDROCHLORIDECVS PHARMACY7acf1a9a-bd97-48bb-8025-ac26070378a22026-08-18WarningsExact identifier
application number: M012
Polytussin DMDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, PYRILAMINE MALEATEPoly Pharmaceuticals, Inc.fda8f594-82bf-1781-e053-6294a90ad3442026-08-18WarningsExact identifier
application number: M012
Mucinex Fast-Max DM Max Honey and Berry FlavorDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCda1f1ef9-a974-4998-8e1d-c1d9995969432026-08-18WarningsExact identifier
application number: M012
CVS Health Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.89168715-71b1-424e-8dae-fcfa90bc85bf2026-08-18WarningsExact identifier
application number: M012
CVS Health SinusOXYMETAZOLINE HYDROCHLORIDECVS PHARMACY, INC.c7840511-3a4f-4547-ae90-19b085a5874e2026-08-17WarningsExact identifier
application number: M012
CVS HealthNASAL OXYMETAZOLINE HCLCVS Pharmacy,Inc.56f08e70-bf16-4933-97bc-177bc190d12a2026-08-17WarningsExact identifier
application number: M012
CVS Health No DripALLERGY NASALCVS PHARMACY,INC.3e76ffac-07a7-4b6a-bc4c-9cabb653e0642026-08-17WarningsExact identifier
application number: M012
CVS dye-free childrens allergyDIPHENHYDRAMINE HYDROCHLORIDECVS PHARMACYdb5a5eff-1bb1-4d00-8c01-caae7a1c72232026-08-17WarningsExact identifier
application number: M012
CVS Overnight Cold and Flu Clear and CoolACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDECVS PHARMACY, INC2497a011-d7a0-4d69-97e2-bbf25a99b1cc2026-08-17WarningsExact identifier
application number: M012
Mucus Relief Cough Cold Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E B3ef949f5-ac8c-44be-b04d-6996fa59a94b2026-08-17WarningsExact 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