NDC 51316-919 - Daytime Cold and Cough Nighttime Cold and Congestion

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
51316-919
Package NDCs from labels
51316-919-03
Manufacturer
CVS | Guardian Drug Company
Effective date
2026-03-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Childrens Daytime Cold and cough - CVS | Guardian Drug CompanyCVS | Guardian Drug Company2026-03-16Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion118 mL in 1 BOTTLELIQUID118 mL6.25 mg in 5mL3
51316-919-03Daytime Cold and Cough Nighttime Cold and Congestion1 in 1 CARTONLIQUID6.25 mg in 5mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-919DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS]2Unmatched20250206_2cf361eb-6055-2364-e063-6294a90a69a1.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 118 of 263 · 5,255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCICardinal Health (Leader) 7000014c507df-fbac-4a09-a66c-b91c2abbf5502025-11-24WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
SleepDIPHENHYDRAMINE HCLSalado Sales, Inc.837c02dd-971b-4451-98d8-9c438c9db6962025-11-24WarningsExact identifier
unii: TC2D6JAD40
Severe Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCIFamily Dollar (FAMILY WELLNESS)e5c90d6e-70aa-4886-bc81-293e0dcf56382025-11-24WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Rain Daily Hydration and Comfort For Dry EyesGLYCERINRain Eye Drops, LLC31d7c204-fb74-fb28-e063-6294a90ab3302025-11-23WarningsExact identifier
unii: PDC6A3C0OX
Throat Coat Eucalyptus MintMENTHOLTraditional Medicinals, Inc.a7a86f1b-30e8-6f5d-e053-2a95a90a2a822025-11-21WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.4538248f-11cc-d6b2-e063-6294a90a652c2025-11-21WarningsExact identifier
application number: M012
Childrens Multi-symptom Cold DaytimeDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores, Inc.1768677d-96ec-f9f7-e063-6394a90a4ef42025-11-21WarningsExact identifier
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
childrens cough dmDEXTROMETHORPHAN POLISTIREXWalgreen Company317ab8e0-c329-4d4e-9fd0-4bff4e1504cd2025-11-20WarningsExact identifier
unii: 9D2RTI9KYH
up and up Daytime Nighttime Childrens Multi Symptom ColdACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDETarget Corporationb8a4da0b-e4d3-48e6-b699-cb56c7b67ed72025-11-20WarningsExact identifier
application number: M012
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Nighttime SleepAidDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANY3802d57e-7943-c0c2-e063-6394a90a75802025-11-20WarningsExact identifier
unii: TC2D6JAD40
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHYVEE INC3e60703b-a5cf-333a-e063-6394a90a20872025-11-20WarningsExact identifier
unii: TC2D6JAD40
Supress DX Pediatric DropsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISddb95436-7806-4086-af4d-18a6625b5c832025-11-20WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
unii: 04JA59TNSJ
Brain LiquescenceGINKGO BILOBA, COLCHICUM AUTUMNALE, CONVALLARIA MAJALIS, NUX MOSCHATA, CEREBRUM (SUIS), AGARICUS MUSCARIUS, SCUTELLARIA LATERIFLORA, ANACARDIUM ORIENTALE, RIBOFLAVINUM, AMBRA GRISEA, BARYTA CARBONICA, GLYCERINUMNutritional Specialties, Inc.a5c366f3-fd42-4602-b20b-b7b15fde564e2025-11-19WarningsExact identifier
unii: PDC6A3C0OX
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
unii: TC2D6JAD40
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc804d7b1f-1be8-50c9-e053-2a91aa0a35d02025-11-18WarningsExact identifier
unii: PDC6A3C0OX
unii: 04JA59TNSJ
Cough Drops Gems Flawless Cherry Flavor 30ctMENTHOLRiclan S.A.0f0260df-89ac-4b83-afea-3aff56ff1b432025-11-18WarningsExact identifier
application number: M012
Cough Drops Gems Flawless Honey Lemon Flavor 30ctMENTHOLRiclan S.A.16f6d531-9298-4172-8d08-ecd87d6add762025-11-18WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINHaleon US Holdings LLCa6f750c8-8738-4965-a3ad-612c246110562025-11-18WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
YINCHIAOACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD.09ba45f6-03e1-46b9-83ab-a618b26267162025-11-18WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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