FDA.reportPublic FDA data

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 37 of 476 · 9,502 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEADER MS Flu Relief NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCARDINAL HEALTH 110, LLC. DBA LEADER9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d2026-07-16WarningsExact identifier
application number: M012
unii: 362O9ITL9D
nighttime sleep aidDIPHENHYDRAMINE HCLAmazon.com Services LLCa8056e5f-e9d8-4555-9212-bf1fa3c154392026-07-16WarningsExact identifier
unii: TC2D6JAD40
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC1bf4cd96-5800-434d-a0dc-e84c759ebb332026-07-16WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Mucus Relief Cough ChildrensDEXTROMETHORPHAN HBR, GUAIFENSINWalgreens2ace231a-94c4-479d-bb26-454bd07b207b2026-07-16WarningsExact identifier
application number: M012
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINE HCLHyVee Inc4f45a750-1220-4a81-801e-bf08c9d117d62026-07-16WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
LEADER No DripALLERGY SINUS NASAL MISTCARDINAL HEALTH 110, LLC. DBA LEADERe7b2c1c1-6250-4af3-b131-22aced2b23d52026-07-16WarningsExact identifier
application number: M012
Mucus Relief DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINAmerisource Bergen639a59b7-ccff-485e-a232-38b6808272292026-07-16WarningsExact identifier
application number: M012
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9d34abc2-3a9a-b68f-80d4-4ede1eb1e45f2026-07-15WarningsExact identifier
unii: 362O9ITL9D
Equate Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.30470a01-4d42-44c6-a017-d68bb74cdef72026-07-15WarningsExact identifier
application number: M012
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENFamily Dollar, Inc.3f182571-3212-eb29-e063-6294a90a9fa02026-07-15WarningsExact identifier
unii: 362O9ITL9D
Hand sanitizerHAND SANITIZER SPRAYBeimei Biotechnology (Guangzhou) Co., Ltd.56a22363-f531-d9bd-e063-6294a90a020b2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Apple SplashALCOHOLMy Imports USA LLCf9113d29-64d7-40fe-986e-7541273a40202026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Berry CremeALCOHOLMy Imports USA LLC66801907-4803-4108-9e82-20fb1562686b2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Beach SandalwoodALCOHOLMy Imports USA LLC4ccaffc1-e9db-4960-96fe-c40cc6ba03992026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Confetti CupcakeALCOHOLMy Imports USA LLCbfca1984-ad8d-4832-90e2-1adc0586fb042026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Gingerbread CakeALCOHOLMy Imports USA LLCca1acaae-6273-44c7-9dd9-5809c6eb37f52026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sugared PlumALCOHOLMy Imports USA LLCddc8e3eb-b3d0-4898-a448-e74eb3e484ac2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Amber GlowALCOHOLMy Imports USA LLC6cc64f29-1ad4-4ab9-aeff-e0966f27c48e2026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer PumpkinALCOHOLMy Imports USA LLC53ee6f2f-b898-4b0b-bc29-7757e9a1f2482026-07-15WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Pistachio GlowALCOHOLMy Imports USA LLCa4e84f2f-b389-4ba7-9e18-33bd9b07825e2026-07-15WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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