Daytime Cold and Cough and NightTime Cold and Congestion

Product NDC: 0363-4590
11-digit product format: 003634590
Labeler code: 0363
Product ID: 0363-4590_b950b789-40c7-4003-bd39-f8ac31ff925e
Type: HUMAN OTC DRUG
Nonproprietary name: Brompheniramine Maleate, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl, Phenylephrine HCl
Dosage form: KIT
Labeler: Walgreens
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-03-04
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: Daytime Cold and Cough and NightTime Cold and Congestion
Brand name suffix: Childrens
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1090463	Internal RxNorm lookup
1236048	Internal RxNorm lookup
1666116	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
2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	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
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0363-4590-08	Daytime Cold and Cough and NightTime Cold and CongestionChildrens	1 in 1 KIT	KIT	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-4590	DAYTIME COLD AND COUGH AND NIGHTTIME COLD AND CONGESTION CHILDRENS (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [WALGREENS]	2	Current NDC, Legacy NDC, 1 package rows	20240622_2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3.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 72 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DayTime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	04f9134e-1311-4843-90db-9244b9e61e1d	2025-12-19	Warnings	Exact identifier application number: M012
Nighttime Cold/Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	029e6215-b72d-4fd0-8918-db1abcc4490a	2025-12-19	Warnings	Exact identifier application number: M012
DayTime and Nighttime Cold/Flu Relief Softgels - Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	5f680f37-b3db-450f-b8ca-f9e31a04dc04	2025-12-19	Warnings	Exact identifier application number: M012
Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Marc Glassman, Inc.	e916ef86-ca73-42dd-83dc-6033f56d96f2	2025-12-19	Warnings	Exact identifier application number: M012
Original Night-Time MULTI-SYMPTOM COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	e243033b-6603-4c3e-a330-e7c7de51f69d	2025-12-19	Warnings	Exact identifier application number: M012
CHILDRENS ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Discount Drug Mart	6fa4f913-de83-4175-9dad-0dedab5b69a1	2025-12-19	Warnings	Exact identifier application number: M012
Day-Time COLD/FLU RELIEF	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	Discount Drug Mart	426db906-9aa4-448f-a361-09c1516efc25	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH SEVERE CONGESTION and COUGH MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Discount Drug Mart	f17385bc-82bb-4183-a4c9-067d8afb3757	2025-12-19	Warnings	Exact identifier application number: M012
MAXIUM STRENGTH DM MAX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Discount Drug Mart	9654fdcd-d660-471f-bc5d-aa7dead7a4a8	2025-12-19	Warnings	Exact identifier application number: M012
Night Time Multi-Symptom Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Discount Drug Mart	8148c2b1-f6ec-4597-8e18-a6597cda5705	2025-12-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	NUVICARE LLC	621ba20e-75c5-42fb-9692-7800f764c978	2025-12-19	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL 10 MG	NUVICARE LLC	4cde41dd-a0a7-45e7-aff3-ee9402dfdff2	2025-12-19	Warnings	Exact identifier application number: M012
COMBINATION PACK TopCare health DayTime SEVERE and NiteTime SEVERE Cold and Flu Relief SOFTGELS - 24 ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	ceb27ff3-cf42-44f9-9ee6-8ea86a0cbe3e	2025-12-19	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3df82c-1926-5238-e063-6294a90a7bbf	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss S/F Grape-Menthol Flavor	GUAIFENESIN, DEXTROMETHORPHAN HBR	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fac3425-32f0-38d6-e063-6394a90a6e7a	2025-12-18	Warnings	Exact identifier application number: M012
NAFASOLINA	NAPHAZOLINE HYDROCHLORIDE	Doral Pharmamedics Inc DBA AG Marin Pharmaceuticals	30cade3d-208f-8594-e063-6394a90ad2a0	2025-12-18	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drop	HONEY LEMON FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ac8a20-206c-0024-e063-6394a90a9d06	2025-12-18	Warnings	Exact identifier application number: M012
Menthol Flavor Cough Drop	MENTHOL FLAVOR COUGH DROP	Army & Air Force Exchange Service	20ace10f-4257-b20e-e063-6394a90a3c7b	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2fabd782-14dc-1d1b-e063-6394a90af428	2025-12-18	Warnings	Exact identifier application number: M012
NeoTuss Plus	DEXTROMETHORPHAN HBR, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals	2f3c6b38-7236-899b-e063-6294a90aabde	2025-12-18	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666116	{1 (brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack	GPCK	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) Pack	PSN	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1090463	brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1236048	diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1090463	brompheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1236048	diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1666116	1 daytime (brompheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) Pack	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1666116	1 daytime (brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) / 1 nighttime (diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1090463	brompheniramine maleate 1 MG / dextromethorphan hydrobromide 5 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1090463	brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1236048	diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2
1236048	diphenhydramine HCl 6.25 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution	SY	2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-4590-08	00363459008	1 KIT in 1 KIT (0363-4590-08) * 118 mL in 1 BOTTLE, PLASTIC * 118 mL in 1 BOTTLE, PLASTIC	1 kit	2022-03-04	0000-00-00	No	No	Current