FDA.reportPublic FDA data

Daytime Nighttime Cold Flu Relief

Product NDC
49035-192
11-digit product format
490350192
Labeler code
49035
Product ID
49035-192_89cec16a-3fb8-4d83-8bae-a53d7ef6ce38
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL
Dosage form
KIT
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-30
NDC exclude flag
No
Listing certified through
2027-12-31
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 Nighttime Cold Flu Relief
Listing expiration
2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup
1094549Internal 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
f288eeca-9803-4962-a802-fe34f5983c7aAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-192-48Daytime Nighttime Cold Flu Relief1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-192DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]3Current NDC, Legacy NDC, 1 package rows20240322_f288eeca-9803-4962-a802-fe34f5983c7a.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 72 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012
DayTime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE04f9134e-1311-4843-90db-9244b9e61e1d2025-12-19WarningsExact identifier
application number: M012
Nighttime Cold/Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE029e6215-b72d-4fd0-8918-db1abcc4490a2025-12-19WarningsExact identifier
application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATEARMY AND AIR FORCE EXCHANGE SERVICE5f680f37-b3db-450f-b8ca-f9e31a04dc042025-12-19WarningsExact 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) } PackGPCKf288eeca-9803-4962-a802-fe34f5983c7a5
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) PackPSNf288eeca-9803-4962-a802-fe34f5983c7a5
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNf288eeca-9803-4962-a802-fe34f5983c7a5
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNf288eeca-9803-4962-a802-fe34f5983c7a5
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDf288eeca-9803-4962-a802-fe34f5983c7a5
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDf288eeca-9803-4962-a802-fe34f5983c7a5
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) PackSYf288eeca-9803-4962-a802-fe34f5983c7a5
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYf288eeca-9803-4962-a802-fe34f5983c7a5
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYf288eeca-9803-4962-a802-fe34f5983c7a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-192-48490350192481 KIT in 1 KIT (49035-192-48) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK1 kit2020-01-300000-00-00NoNoCurrent