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
Label	Manufacturer	Effective date	Type
Nighttime Severe Cold and Cough - P & L Development, LLC	P & L Development, LLC	2024-04-15	HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49580-0502-8	2023-05-17	C162847	48780-1	f386c649-e055-0266-e053-dadaa90a7c1a	Drug Facts
49580-0502-8	2023-01-30	C162847	48780-1	f386c649-e055-0266-e053-dadaa90a7c1a	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49580-0502-8	Nighttime Severe Cold and Cough	245 mL in 1 BOTTLE, PLASTIC	LIQUID	245		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49580-0502	NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [P & L DEVELOPMENT, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20240417_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 39 of 476 · 9,502 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Hand sanitizer 8oz with vitamin E	ETHYL ALCOHOL 70%	REJOICE INTERNATIONAL CORP.	03f4a507-df3f-e265-e063-6294a90acd11	2026-07-13	Warnings	Exact identifier unii: 3K9958V90M
Hand sanitizer 8oz with aloe vera	ETHYL ALCOHOL 70%	REJOICE INTERNATIONAL CORP.	03f81b63-2b08-77b1-e063-6294a90afeba	2026-07-13	Warnings	Exact identifier unii: 3K9958V90M
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012 unii: 362O9ITL9D
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENT	ETHYL ALCOHOL	Amber Glow Cosmetics Limited	7171f607-90cc-4750-9928-20792ac2eaa2	2026-07-13	Warnings	Exact identifier unii: 3K9958V90M
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	Warnings	Exact identifier application number: M012
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENT	ETHYL ALCOHOL	Amber Glow Cosmetics Limited	3417a685-544b-4dd0-b3e9-b5c463a679b6	2026-07-13	Warnings	Exact identifier unii: 3K9958V90M
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	Bryant Ranch Prepack	8a4cf981-37f7-4bc9-a9d7-b134a5fd0894	2026-07-13	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 362O9ITL9D
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENT	ETHYL ALCOHOL	Amber Glow Cosmetics Limited	91d4c729-ebbe-45db-a4cd-dbf6bd542a29	2026-07-13	Warnings	Exact identifier unii: 3K9958V90M
Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	404a3521-8340-4476-a068-0e69cd0e514f	2026-07-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5	2026-07-13	Warnings	Exact identifier application number: M012 unii: 04JA59TNSJ unii: 362O9ITL9D
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Cardinal Health 110, LLC. DBA Leader	f1cd0d59-12a8-4ff2-942a-6faa6907ef05	2026-07-13	Warnings	Exact identifier unii: 362O9ITL9D
Good Neighbor Long Acting Cough Adult Tussin	DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	df3c76bd-bd5b-42d7-a5f1-560fd3cba646	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	a217ca8a-1c00-4816-bc26-cc0f71c80c90	2026-07-13	Warnings	Exact identifier application number: M012

Reported adverse events (FAERS/openFDA)#

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