Daytime Cold and Flu

Product NDC: 0363-0853
11-digit product format: 003630853
Labeler code: 0363
Product ID: 0363-0853_13b1a0d2-6b18-a20f-e063-6294a90a35b2
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophine Dextromethorphan HBr Phenylphrine HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: WALGREENS
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-10-15
Substance: PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength: 5; 10; 325 mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 Flu
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
ACETAMINOPHEN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1086997	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
d315bc95-1b46-75df-e053-2a95a90a6c66	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0853-07	Daytime Cold and Flu	10 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	10	3
0363-0853-07	Daytime Cold and Flu	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	3
0363-0853-16	Daytime Cold and Flu	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8	3
0363-0853-16	Daytime Cold and Flu	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	3
0363-0853-24	Daytime Cold and Flu	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2	3
0363-0853-24	Daytime Cold and Flu	12 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	12	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0853	DAYTIME COLD AND FLU (ACETAMINOPHINE DEXTROMETHORPHAN HBR PHENYLPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREENS]	3	Current NDC, Legacy NDC, 6 package rows	20240316_d315bc95-1b46-75df-e053-2a95a90a6c66.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 81 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu	DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	b13d5132-cb91-3cf6-e053-2a95a90aa47c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	bd97e91f-1ae1-379c-e053-2995a90acfdd	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Powermax	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	a6a2dd4a-a3c8-2dfa-e053-2995a90ada86	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	bd49121c-7cba-c51f-e053-2995a90a921e	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare, LLC.	a6b8dc25-0fb9-1823-e053-2a95a90adf93	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	c2232241-6e57-1427-e053-2995a90a488a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels	ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	51dec468-fbb2-3489-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	d7711cd6-5058-548d-e053-2a95a90ac54d	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	a2f0285b-8550-fd26-e053-2995a90ab615	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	f6c73f61-f4fc-377f-e053-6294a90a3797	2025-12-04	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Bayer Healthcare LLC.	a32e2a5e-9aa0-4e7c-e053-2995a90a3190	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	e2877488-3539-cba2-e053-2995a90a6005	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChews	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	14951faa-9476-6f29-e063-6394a90a14c7	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels	ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION	Bayer HealthCare LLC.	0c120569-622d-3a23-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChews	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Bayer HealthCare LLC.	149330be-24bd-b4a4-e063-6394a90a9007	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN	Bayer HealthCare LLC.	5278a128-41ec-4494-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Orange Zest	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	53188c41-3f13-311b-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Day and Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	75894849-a0ba-57be-e053-2a91aa0a049a	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Sparkling Original	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	531ab703-179a-70ad-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Cold Night	ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	7588ea67-68a9-4dc0-e053-2991aa0aa471	2025-12-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2634564	{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack	GPCK	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	PSN	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
2634564	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack	SY	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	c945c35e-de0d-0fd6-e053-2995a90a1fbf	5
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	d315bc95-1b46-75df-e053-2a95a90a6c66	3
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	d315bc95-1b46-75df-e053-2a95a90a6c66	3
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	d315bc95-1b46-75df-e053-2a95a90a6c66	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0853-07	00363085307	1 BLISTER PACK in 1 CARTON (0363-0853-07) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 blister pack	2023-07-03		No	No	Current
0363-0853-16	00363085316	2 BLISTER PACK in 1 CARTON (0363-0853-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2021-10-15	0000-00-00	No	No	Current
0363-0853-24	00363085324	2 BLISTER PACK in 1 CARTON (0363-0853-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2021-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
695T 0363 0729 WALGREENS - Daytime Nighttime Cold & Flu	WALGREENS \| TIME CAP LABORATORIES, INC. \| MARKSANS PHARMA LIMITED	2024-03-19	HUMAN OTC DRUG LABEL	5
Walgreens Daytime Cold & flu Softgels	WALGREENS \| TIME CAP LABORATORIES INC. \| MARKSANS PHARMA LIMITED	2024-03-15	HUMAN OTC DRUG LABEL	3