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 149 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiflu Des Cough and FluACETAMINOPHEN PHENYLEPHRINE HCL CHLORPHENIRAMINE MALEATEProductos Farmaceuticos, S.A. de C.V.dcf3897a-a793-6df7-e053-2995a90a25f82024-10-17WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFSA STORE INC.ec6aef90-ece1-4fe6-e053-2995a90a93102024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Cold, Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Incc8eebe64-00bf-436d-a9fc-1623401bebfa2024-10-16WarningsExact identifier
application number: M012
AllergyDIPHENHYDRAMINE HYDROCHLORIDEDiscount Drug Mart4f42c8d2-0538-4bcd-aac0-e26103a304992024-10-16WarningsExact identifier
application number: M012
Tukol MAX ACTION Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGenomma Lab USA, Inc9ac3e24a-d18a-48fc-8005-55393085d57b2024-10-16WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED45471fdd-c4cd-46ad-a932-aa37327e8a412024-10-16WarningsExact identifier
application number: M012
DG Health Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc8cb15a8d-c836-4167-bc6b-dd20a34076e82024-10-16WarningsExact identifier
application number: M012
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLCf4497e56-c69d-4ae9-bd81-80bf2ee1b17f2024-10-15WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEFOODHOLD U.S.A., LLC8256c1fb-683d-56ab-e053-2a91aa0ac1972024-10-15WarningsExact identifier
application number: M012
SINUS SEVREACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f9586e3-a8b4-4060-e053-2995a90aa0682024-10-15WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95715f-63dc-6086-e053-2a95a90adb0c2024-10-15WarningsExact identifier
application number: M012
Allergy MultiSymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.a61636e9-8fe2-8419-e053-2a95a90a011c2024-10-15WarningsExact identifier
application number: M012
SINUS AND HEADACHEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f95b2e8-dea4-ef59-e053-2a95a90a0bcb2024-10-15WarningsExact identifier
application number: M012
Cold Multi-Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEAmerican Sales Companyd2dcbc7c-e66c-4922-83df-c706a37bf3342024-10-15WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC. (9f958d97-8dcf-332d-e053-2995a90a0a652024-10-15WarningsExact identifier
application number: M012
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERetail Business Services , LLC.8bc68a71-62c5-a04f-e053-2995a90a92fd2024-10-15WarningsExact identifier
application number: M012
COLD FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.9f960566-0158-6637-e053-2995a90a9c4a2024-10-15WarningsExact identifier
application number: M012
HEAD CONGESTION PLUS FLU SEVERE PEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.e65cf21d-3d69-a53e-e053-2a95a90a1c832024-10-15WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E B49f5f4d3-556c-4ee3-b5cd-5331dd434bb92024-10-15WarningsExact identifier
application number: M012
Mielim y masDEXTROMETHORPHANEfficient Laboratories Inc.711d1dae-3af4-46af-a3a8-cd827356a81a2024-10-14WarningsExact 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