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 9 of 478 · 9,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a50402b-e4d7-3c0b-e063-6394a90a5e522026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a508fad-c7a4-82e8-e063-6294a90a0de12026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Beaded Wristlet - EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f160d3-7e42-ef07-e063-6394a90a6f8f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut HoneyALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2ab646-2dba-5111-e063-6394a90acc4f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry BlissALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2b50a2-6ee2-04d4-e063-6294a90a1c652026-08-29WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a2c11e6-a105-5362-e063-6394a90a132f2026-08-29WarningsExact identifier
unii: 3K9958V90M
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLC69af44c2-390c-4223-889a-d5555aef57782026-08-28WarningsExact identifier
application number: M012
unii: TC2D6JAD40
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
Wal Som Nighttime Sleep Aid NighttimeDIPHENHYDRAMINE HCLWalgreens4cb0f9ab-1be1-4b41-a233-bbd0327036e22026-08-28WarningsExact identifier
unii: TC2D6JAD40
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLYour Military Exchanges13fcc43c-bdda-4b65-b6d7-23b39e6836512026-08-28Warnings, Adverse reactionsExact identifier
application number: M012
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and EspressoALCOHOLShenzhen Lantern Scicence Co.,Ltd.59ef14d6-1a40-ea3c-e063-6394a90af4422026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling PomegranateALCOHOLShenzhen Lantern Scicence Co.,Ltd.597530cb-03f6-b72d-e063-6394a90a0d6c2026-08-28WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink PeonyALCOHOLShenzhen Lantern Scicence Co.,Ltd.59f1521c-ad5c-e2d6-e063-6394a90a4e2b2026-08-28WarningsExact identifier
unii: 3K9958V90M
Multi-Symptom AllergyACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreen Company5170c450-989d-44fa-ab38-86c78feae3b62026-08-28WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Alcare Extra Hand SanitizerALCOHOLSC Johnson Professional USA Inc.5dc007a2-61fa-4115-a82c-1aa489a6bd392026-08-27WarningsExact identifier
unii: 3K9958V90M
Pain Reliever PM Extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens54cbbc5f-908b-47b2-b37f-3646354d35682026-08-27WarningsExact identifier
application number: M012
unii: TC2D6JAD40
unii: 362O9ITL9D
Maximum Strength Mucus ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLHyvee Inc4e578c7a-88d4-e4cd-e063-6394a90aac442026-08-27WarningsExact identifier
application number: M012
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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