NDC 49580-0466-01 - Daytime Cold and Flu

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
49580-0466
Requested NDC
49580-0466-01
Package NDCs from labels
49580-0466-6, 49580-0466-1, 49580-0466-2, 49580-0466-4, 49580-0466-01
Manufacturer
P & L Development, LLC
Effective date
2025-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Daytime Cold and Flu - P & L Development, LLCP & L Development, LLC2025-07-08HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49580-0466-12023-10-13Drug Facts
49580-0466-22023-10-13Drug Facts
49580-0466-42023-10-13Drug Facts
49580-0466-62023-10-13Drug Facts
49580-0466-12023-01-30Drug Facts
49580-0466-22023-01-30Drug Facts
49580-0466-42023-01-30Drug Facts
49580-0466-62023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0466-1Daytime Cold and Flu296 mL in 1 BOTTLE, PLASTICLIQUID29611
49580-0466-2Daytime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID35511
49580-0466-4Daytime Cold and Flu118 mL in 1 BOTTLE, PLASTICLIQUID11811
49580-0466-6Daytime Cold and Flu177 mL in 1 BOTTLE, PLASTICLIQUID17711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0466DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]10Current NDC, Legacy NDC, 4 package rows20240426_0bb006f6-c360-4cd5-81e9-0776d99d79e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDAYTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [P & L DEVELOPMENT, LLC]1

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 6 of 371 · 7,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Afrin Original NasalOXYMETAZOLINE HYDROCHLORIDEJC World Bell Wholesale Co., Inc.ecfa14b8-a3f3-4569-b489-c9e1a51cf09e2026-08-31WarningsExact identifier
application number: M012
Dextromethorphan HBrDEXTROMETHORPHAN HBRBIONPHARMA INC.5a5dde85-8785-8149-e063-6294a90a4d572026-08-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Equate NasalOXYMETAZOLINE HCLSixarp, LLC5a5e2458-bab0-4931-e063-6394a90ad6062026-08-31WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEFDEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOLReckitt Benckiser LLC8d670d91-9e22-45b9-b568-5b62c2133d322026-08-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
MAX relief junior GrapeCHILDRENS ACETAMINOPHENAkron Pharma Inc.cc769c26-556a-4831-bd75-61a7383aa7072026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDRENS ACETAMINOPHENAkron Pharma Inc.ebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472026-08-31WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
unii: 362O9ITL9D
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX Tussin Mucus and Chest Congestion Sugar FreeGUAIFENESINAkron Pharma Inc.3b023b91-e703-4599-9864-96d8c328b45c2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Mucus and Chest CongestionGUAIFENESINAkron Pharma Inc.ac874a31-5556-4669-937f-dcb52aaecd8a2026-08-31WarningsExact identifier
application number: M012
MAX Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINAkron Pharma Inc.e0ce4287-bfa1-4413-97c8-4fe2e39bda362026-08-31WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Mucinex DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDESelect Consumer Group3c9c8fb0-8a00-4b0f-e063-6394a90af6322026-08-30WarningsExact identifier
unii: 9D2RTI9KYH
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
unii: 362O9ITL9D
Tussin DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED432d4833-2eaf-4f7c-b6b4-41043a6b7e2a2026-08-28WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.