Nighttime Severe Cold and Cough

Product NDC: 49580-0502
11-digit product format: 495800502
Labeler code: 49580
Product ID: 49580-0502_48c92b40-7cf7-492b-96d4-d4209532fcdc
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: LIQUID
Route: ORAL
Labeler: P & L Development, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-04-30
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Nighttime Severe Cold and Cough
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/30mL
PHENYLEPHRINE HYDROCHLORIDE	10 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	Internal UNII lookup
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1298348	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d27b94d-23a1-4e6c-a064-79e2580f7e2e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

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 131 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Nighttime Severe, 24-7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store products, Inc.	05d0410f-164e-e7ee-e063-6394a90a2aaa	2024-12-16	Warnings	Exact identifier application number: M012
tussin dm max daytime nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN	CVS Pharmacy	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	2024-12-16	Warnings	Exact identifier application number: M012
Leader Childrens Multi Symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	169ff9cf-fcf5-46a6-b460-259421f2ec07	2024-12-16	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012
CVS Vapor Steam	CAMPHOR (SYNTHETIC)	CVS	49da2c40-afc5-5770-e054-00144ff88e88	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Daytime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Company	e428dd83-c538-2a92-e053-2a95a90a0e16	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Nighttime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Company	e46291c7-6f4d-46a2-e053-2a95a90a80a1	2024-12-13	Warnings	Exact identifier application number: M012
Foster and Thrive Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	7eaba464-5cdb-4bd4-b272-38fa108658d5	2024-12-13	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride 25mg	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Strive Pharmaceuticals Inc	b440eb2e-4de9-2b65-e053-2995a90abda8	2024-12-11	Warnings	Exact identifier application number: M012
Meijer Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	6933ca9d-a32d-d856-e053-2a91aa0a408e	2024-12-10	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	826b5c0d-7a75-bbf0-e053-2a91aa0aebd6	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	09141018-37ba-4c93-9051-1ed129c448c1	2024-12-10	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola USA Inc.	6ac9d95b-f6b9-4515-b126-697f8f839612	2024-12-10	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola USA Inc.	989d1529-2875-47bf-81df-65494d62be7a	2024-12-10	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1298348	acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	3
1298348	acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	3
1298348	acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	3
1298348	acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	3
1298348	APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY	8d27b94d-23a1-4e6c-a064-79e2580f7e2e	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49580-0502-8	49580050208	245 mL in 1 BOTTLE, PLASTIC (49580-0502-8)	245 ml	2021-04-30	0000-00-00	No	No	Current