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 54 of 476 · 9,502 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Regular StrengthACETAMINOPHENCVS PHARMACY5e35df92-6282-4ca6-902b-bb6bd326b4872026-06-23WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizers 2pk Apple and MarshmallowALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6b242-6f50-0e3e-e063-6294a90a52692026-06-23WarningsExact identifier
unii: 3K9958V90M
Meijer Hand Sanitizer Silicone Holiday Gift Set 3pkALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e6ecb7-5cd5-fc13-e063-6294a90a038c2026-06-23WarningsExact identifier
unii: 3K9958V90M
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
Family Beauty Hydrating Hand Sanitizer, Aloe ScentedALCOHOLFamily Dollar Stores, LLC394c35ad-90b1-476c-84b9-2dbf973444532026-06-23WarningsExact identifier
unii: 3K9958V90M
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Pain RelieverACETAMINOPHENOrelli Inc.4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d2026-06-22WarningsExact identifier
unii: 362O9ITL9D
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Smart Care Hand Sanitizers 2pk Cherry Blossom and French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.54e431cd-98fb-8346-e063-6294a90ad85e2026-06-22WarningsExact identifier
unii: 3K9958V90M
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBest Choice (Valu Merchandisers Company)bfec14d5-d9ce-4b9c-a803-3d01cb00b56c2026-06-22WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Sleep-AidDIPHENHYDRAMINE HCLRite Aid Corporation1a5668df-2bbc-4724-af39-19d30a8920f32026-06-22WarningsExact identifier
unii: TC2D6JAD40
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC5f1aaa8e-c65f-43b3-9850-c60c1663d78f2026-06-22WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
DAY TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.e5a64d5a-c1ff-453d-b0c1-fe265b9e2c8a2026-06-22WarningsExact identifier
application number: M012
unii: 362O9ITL9D
NO DRIP NASALPHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7a866cdf-1c0c-403a-afc8-0e99e0ce81aa2026-06-22WarningsExact identifier
application number: M012
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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