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 56 of 476 · 9,502 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ChildrensDIPHENHYDRAMINE HCLDOLGENCORP, LLC218c447e-9ddd-428a-9b33-0acec35e0d1b2026-06-17WarningsExact identifier
application number: M012
unii: TC2D6JAD40
dg health 8 hr arthritis pain reliefACETAMINOPHENDolgencorp Incfc7838a7-fc6d-41b7-b8e4-97bee2bfa6d42026-06-17WarningsExact identifier
unii: 362O9ITL9D
AshleyBelle Moisturizing Hand Sanitizer Pineapple SoleilETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.48dfb925-add2-f9ef-e063-6394a90a3bab2026-06-17WarningsExact identifier
unii: 3K9958V90M
AcetaminophenACETAMINOPHENOncor Pharmaceuticals4c396d0e-aa93-4f9e-b065-2e606f7f05cd2026-06-17WarningsExact identifier
unii: 362O9ITL9D
Smart Care Hand Sanitizer Holiday-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e55a6-7d63-2344-e063-6294a90ab4c02026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
unii: 3K9958V90M
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWALMART INC.a9d5f9f4-ddec-4ad6-ad06-4a612008bb682026-06-17WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Childrens Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Companye49d2a0f-6588-439b-8a46-c073e0bc4f9a2026-06-17WarningsExact identifier
application number: M012
unii: TC2D6JAD40
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESafewayac0380ad-c9fa-4bda-ab84-c2e6aa672bdf2026-06-17WarningsExact identifier
application number: M012
unii: 362O9ITL9D
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Sleep Aid Night TimeDIPHENHYDRAMINE HCLDOLGENCORP, LLC9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e82026-06-16WarningsExact identifier
unii: TC2D6JAD40
Sleep AidDIPHENHYDRAMINE HCLTopco Associates, LLC57a81e24-ef0d-4143-b266-71e2d4be76172026-06-16WarningsExact identifier
unii: TC2D6JAD40
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
unii: 3K9958V90M
Tussin DM RegularDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.5460c809-71c8-3ad6-e063-6294a90a4e4f2026-06-16WarningsExact identifier
application number: M012
Medi First Extra Strength Itch ReliefDIPHENHYDRAMINE, ZINC ACETATEUnifirst First Aid Corporation54614e5b-8c72-d308-e063-6294a90a405d2026-06-16WarningsExact identifier
unii: TC2D6JAD40
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC546347e5-841e-15ca-e063-6294a90a0c8b2026-06-16WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERIN SUPPOSITORYEverpharm LLC5463f869-2b92-4551-e063-6394a90ad6f92026-06-16WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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