NDC 49580-0502-08 - Nighttime Severe Cold and Cough

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
49580-0502
Requested NDC
49580-0502-08
Package NDCs from labels
49580-0502-8, 49580-0502-08
Manufacturer
P & L Development, LLC
Effective date
2024-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nighttime Severe Cold and Cough - P & L Development, LLCP & L Development, LLC2024-04-15HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49580-0502-82023-05-17C16284748780-1f386c649-e055-0266-e053-dadaa90a7c1aDrug Facts
49580-0502-82023-01-30C16284748780-1f386c649-e055-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0502-8Nighttime Severe Cold and Cough245 mL in 1 BOTTLE, PLASTICLIQUID2453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0502NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 1 package rows20240417_8d27b94d-23a1-4e6c-a064-79e2580f7e2e.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 63 of 475 · 9,485 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
unii: 362O9ITL9D
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companyb0c1d635-0f85-433a-b479-51c68d259faa2026-06-03WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWalgreen Companyde4e8af4-d3d0-44b3-aea3-79016803ccdc2026-06-03WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
unii: 362O9ITL9D
STRAWBERRY SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limited8c9ddf82-fcc8-4575-8a3a-ce11542c3ab42026-06-03WarningsExact identifier
unii: 3K9958V90M
WATERMELON SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limitedf49efe3b-5ad7-4658-a1a7-1e46f48d17842026-06-03WarningsExact identifier
unii: 3K9958V90M
CUPCAKE SCENT HAND SANITIZERETHYL ALCOHOLAmber Glow Cosmetics Limitedd1d92aa2-23e6-4c0f-a3da-e00536b606752026-06-03WarningsExact identifier
unii: 3K9958V90M
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
unii: 04JA59TNSJ
Mucus Relief DMDEXTROMETHORPHAN HBR AND GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICEdc0a3761-bbe2-4261-a183-594f5fb12b0b2026-06-03WarningsExact identifier
application number: M012
Cold and Flu Daytime, NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLWALMART INC.f278cc81-65b2-4e45-be5b-41152cbb67c42026-06-03WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLFamily Dollar Services Inc358ba91d-06a4-49c9-994d-4e4bf9499dcd2026-06-03WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
GUAIFENESIN DMGUAIFENESIN AND DEXTROMETHORPHANCardinal Health 107, LLCc5fd53c9-81d6-4ce6-88a0-c2c24e17a7ed2026-06-02WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu plus Congestion Severe Fast Hot Liquid NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5349dbde-730c-610f-e063-6394a90a952a2026-06-02WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
ATTITUDE Little leaves Hand Sanitizer Vanilla and PearETHYL ALCOHOL9055-7588 Quebec Inc. DBA Attitude09bee97d-a8e4-7c9c-e063-6294a90a04122026-06-02WarningsExact identifier
unii: 3K9958V90M
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATECardinal Health 107, LLCa9130f36-4761-4e6b-a383-eca3db06ea932026-06-02WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY MENSTRUAL PAIN RELIEFACETAMINOPHENAmerisource Bergenae07a064-fdbd-4bb4-8252-9c122bf3dd812026-06-02WarningsExact identifier
unii: 362O9ITL9D
Topcare Day Time Nite Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCaed387e0-5a8b-4caf-a373-3e04496a49832026-06-02WarningsExact identifier
application number: M012
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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