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
Label	Manufacturer	Effective date	Type
Childrens Daytime Cold and cough - CVS \| Guardian Drug Company	CVS \| Guardian Drug Company	2026-03-16	Human OTC Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51316-919-03	Daytime Cold and Cough Nighttime Cold and Congestion	118 mL in 1 BOTTLE	LIQUID	118 mL	6.25 mg in 5mL	3
51316-919-03	Daytime Cold and Cough Nighttime Cold and Congestion	1 in 1 CARTON	LIQUID		6.25 mg in 5mL	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51316-919	DAYTIME COLD AND COUGH NIGHTTIME COLD AND CONGESTION (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [CVS]	2	Unmatched	20250206_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 183 of 261 · 5,218 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	82813342-2be2-4731-ae90-dbd5eed667a9	2024-12-10	Warnings	Exact identifier application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	b640a5d2-a7fe-486d-a65f-e7c993f950d6	2024-12-10	Warnings	Exact identifier application number: M012
Sugar Free Mountain Herb Cough Suppressant Throat Drops	MENTHOL	Ricola USA Inc.	c3f3c062-55e5-43c1-a016-ee47a7b388a5	2024-12-10	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE SWISS CHERRY	MENTHOL	Ricola USA Inc.	ee4733b5-6e5a-438a-97da-110f3ef6c809	2024-12-10	Warnings	Exact identifier application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPS	MENTHOL	Ricola USA Inc.	f62fcc38-2d43-40b3-841f-c8eea9ebd1e1	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	8a6db093-7e52-443f-8dd6-94867606fef8	2024-12-10	Warnings	Exact identifier application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINT	MENTHOL	Ricola USA Inc.	5885343e-4a6e-44f7-87a4-d52599156197	2024-12-10	Warnings	Exact identifier application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANT	MENTHOL	Ricola USA Inc.	0baf383c-886d-47ca-8a6d-221298c79446	2024-12-10	Warnings	Exact identifier application number: M012
Tussin Multi Symptom Cold CF	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE	Best Choice (Valu Merchandisers Company)	539b8972-2a46-468e-ad27-6672d746feb7	2024-12-10	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	db2ab9be-507d-4768-9d00-188f751b7726	2024-12-10	Warnings	Exact identifier application number: M012
Adult Allergy Relief	CALMCO ALLERGY RELIEF	CalmCo	08288825-0f38-b6a3-e063-6394a90aa358	2024-12-07	Warnings	Exact identifier application number: M012 unii: TC2D6JAD40
CalmCo Sleep Aid Gummy Bite	DIPHENHYDRAMINE HCL	CalmCo LLC	0c534cbd-40e6-8af0-e063-6394a90a5605	2024-12-07	Warnings	Exact identifier unii: TC2D6JAD40
Somnapure Clinical Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Force Factor Brands LLC	063517c0-bcb1-46dd-85f1-bbb2f24274ef	2024-12-06	Warnings	Exact identifier unii: TC2D6JAD40
Original Herb Cough Drops	MENTHOL	Ricola Ag	c142663f-086e-4ab7-a758-9107d7077537	2024-12-05	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola Ag	984c9793-163c-4b97-b244-9b471966a122	2024-12-05	Warnings	Exact identifier application number: M012
BENZEDREX	PROPYLHEXEDRINE	BF ASCHER AND CO INC	00d8c237-3eee-1d9f-e063-6394a90aeb86	2024-12-05	Warnings	Exact identifier application number: M012
Cold Multi Symptom Daytime Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Chain Drug Marketing Association	d5cbb5b0-564c-429e-b680-fa683e796393	2024-12-05	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCare	de8a623f-7b10-4d56-a74b-3737e7716ffe	2024-12-05	Warnings	Exact identifier application number: M012
Cold Max Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	9773958b-c5e5-4da7-a8e9-6b6c223a2b30	2024-12-05	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ
Cold Plus Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	TopCo Associates LLC	399e0e51-c2a7-451c-b74d-d3db140cef69	2024-12-05	Warnings	Exact identifier application number: M012 unii: 9D2RTI9KYH unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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