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 40 of 476 · 9,502 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scentfull Hand Sanitizer Pink ChampagneALCOHOLScent Theory Products LLC565650e6-e5f9-c010-e063-6394a90aacfa2026-07-11WarningsExact identifier
unii: 3K9958V90M
Scentfull Hand Sanitizer Blue DriftwoodALCOHOLScent Theory Products LLC56572ebe-d624-6389-e063-6394a90a23b42026-07-11WarningsExact identifier
unii: 3K9958V90M
Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company1ddc04fb-069c-44fe-814b-ba4f503c4be02026-07-10WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
COUGH DROPS- menthol granuleMENTHOL GRANULEAnhui Jiuhe Health Industry Co., Ltd5351b943-5830-e4e7-e063-6394a90a5b662026-07-10WarningsExact identifier
application number: M012
Purell Advanced SoothingALCOHOLGOJO Industries, LLC59b47629-8b4e-4084-8bc8-66c7e5599e9c2026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Gentle and Free FoamALCOHOLGOJO Industries, LLC70b13f86-4d1a-4221-b09d-7438163fe9b52026-07-10WarningsExact identifier
unii: 3K9958V90M
PURELL Advanced Hand Sanitizer Fragrance Free FoamALCOHOLGOJO Industries, LLC63c26f36-4bae-4cce-bacb-d0da66b228f72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Fresh SqueezeALCOHOLAmerican Exchange Group6a668197-1fa8-4c07-a520-20e194df39c52026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Paradise PleaseALCOHOLAmerican Exchange Group6d75c795-ff84-4775-8f7d-a2416acf845e2026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Hinoki HourALCOHOLAmerican Exchange Group303866ab-8b9f-4e74-8408-62e57bb731d72026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer, Pineapple PopALCOHOLAmerican Exchange Group20aa290f-39e4-4bc9-9128-d6268d8d74d02026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Vanilla DaydreamALCOHOLAmerican Exchange Groupa188f0ef-75fa-4ace-8712-7ce592ae19572026-07-10WarningsExact identifier
unii: 3K9958V90M
NatureWell Hydrating Hand Sanitizer Clean GirlALCOHOLAmerican Exchange Groupf5588dff-3299-47c5-a570-94c346b6b2e92026-07-10WarningsExact identifier
unii: 3K9958V90M
ValuMeds Nasal Decongestant PE PhenylephrinePHENYLEPHRINE HYDROCHLORIDECabinet Health P.B.C.3f284420-87c1-4c17-99e5-bc569bf9d45f2026-07-10WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Smart Care CHAMPAGNE TOAST 2 HAND SANITIZERS 1.35 FL OZETHYL ALCOHOLAshtel Studios, Inc.1bd51131-b3df-4cf9-959b-45724484ffc62026-07-10WarningsExact identifier
unii: 3K9958V90M
Severe Congestion and Cough Multi-Symptom Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy707eb066-cdfc-444b-833a-9d6d133d48e42026-07-10WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Sinus CongestionPHENYLEPHRINE HCLL.N.K. International, Inc.81f0276a-99a2-4a57-a0d8-224735aa8c792026-07-10WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
SINUS AND HEADACHEACETAMINOPHEN, PHENYLEPHRINE HCLRite Aid Corporationefaf3be1-ab39-45f7-a45c-7fea8705c8d02026-07-10WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Equate Daytime Nighttime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWALMART INC.f847d9f2-aa47-4bbe-8f06-19356c6373982026-07-10WarningsExact identifier
application number: M012
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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