Daytime Cold and Flu

Product NDC: 69168-417
11-digit product format: 691680417
Labeler code: 69168
Product ID: 69168-417_c2498c7c-a983-4ee4-b796-e0f844c9fcd0
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg
Dosage form: CAPSULE
Route: ORAL
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-11-11
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 5 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
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

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
9D2RTI9KYH	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
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
bed5f9dc-45ea-4e90-86c6-86599b6f3861	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
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
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	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
69168-417-93	Daytime Nighttime Cold and Flu Relief Combo Pack	12 in 1 BLISTER PACK	CAPSULE	24	5 mg	6
69168-417-93	Daytime Nighttime Cold and Flu Relief Combo Pack	2 in 1 CARTON	CAPSULE		5 mg	6
69168-417-29	Daytime Cold and Flu	8 in 1 BLISTER PACK	CAPSULE	8		3
69168-417-51	Daytime Cold and Flu	10 in 1 BLISTER PACK	CAPSULE	10		3
69168-417-51	Daytime Cold and Flu	2 in 1 CARTON	CAPSULE	2		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-417	DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK (DAYTIME NIGHTTIME COLD AND FLU) KIT [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC	20231020_fa7ed5db-4da7-46b4-a08d-1d79cb7a5674.zip
69168-417	DAYTIME COLD AND FLU (ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG) CAPSULE [ALLEGIANT HEALTH]	3	Current NDC, Legacy NDC, 3 package rows	20231116_bed5f9dc-45ea-4e90-86c6-86599b6f3861.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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	51e34704-5e6b-4e80-836c-ddbc24a451b2	2026-03-06	Warnings	Exact identifier application number: M012
Medi-First Plus Sinus Decongestant	PHENYLEPHRINE HYDROCHLORIDE	Sportpharm LLC	20f58b0b-c123-477f-a62c-fa5423e23f93	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength	PHENYLEPHRINE HCL	Sportpharm LLC	7f4e8d37-8c6b-4849-b86c-4335a0bcac1c	2026-03-06	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cold and Flu Kit	DAYTIME AND NIGHTTIME COLD AND FLU KIT	Allegiant Health	0533db78-7809-46ea-9998-deb5f6f1d0d9	2026-03-06	Warnings	Exact identifier application number: M012
Nasal Decongestant PE	PHENYLEPHRINE HCL	Better Living Brands, LLC	0153294d-7f52-4d92-8db8-daeca3e29a3b	2026-03-06	Warnings	Exact identifier application number: M012
Mucus DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Meijer Distribution, Inc.	87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e	2026-03-06	Warnings	Exact identifier application number: M012
RYNEX PE	BROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	EDWARDS PHARMACEUTICALS, INC.	77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef	2026-03-05	Warnings	Exact identifier application number: M012
Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Best Choice (Valu Merchandisers Company)	042f9449-4af0-4b15-bb3e-236afeb1e11f	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN	Amerisource Bergen	087a3a0b-8d3f-45ed-8807-0af47b446cac	2026-03-05	Warnings	Exact identifier application number: M012
Mucus Relief DM	DEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MG	NUVICARE LLC	6c4bc7d1-09d9-4311-8457-a1d47ab02a5a	2026-03-05	Warnings	Exact identifier application number: M012
Allergy Relief childrens	DIPHENHYDRAMINE HCL	WALMART INC.	dceb99a9-4aa3-4acc-b632-9a4ba8c87919	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Childrens Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	AMAZON.COM SERVICES LLC	26101105-a6cf-4b51-a639-9d078542fea3	2026-03-04	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	Major Pharmaceuticals	3a976e90-c6af-4414-984e-9987158c9e98	2026-03-04	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Best Choice (Valu Merchandisers Company)	714e93ec-0aa9-4be2-9311-399e82f148e0	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Best Choice (Valu Merchandisers Company)	d1131759-dd2e-4c06-bb73-92dd975f5511	2026-03-04	Warnings	Exact identifier application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	AMAZON.COM SERVICES LLC	6bbe8cc9-7a60-4476-b5cf-b13c5bebff26	2026-03-04	Warnings	Exact identifier application number: M012
Severe Cold and Flu Daytime, Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5a1dfaf3-370d-4ac7-a72d-a48863a35741	2026-03-04	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Walgreen Company	c5cb09d4-c049-461c-8898-2c5bb6a8a138	2026-03-04	Warnings	Exact identifier application number: M012
Tussin CF	DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL	WinCo Foods, LLC	3d96d6d0-8c04-43bb-aed0-4cd00cdf3456	2026-03-04	Warnings	Exact identifier application number: M012
DayTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	H E B	e2994c0f-add8-4f75-a6d2-24cd2af271e4	2026-03-03	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
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

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	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
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	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
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	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	6
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	bed5f9dc-45ea-4e90-86c6-86599b6f3861	3
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	bed5f9dc-45ea-4e90-86c6-86599b6f3861	3
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	bed5f9dc-45ea-4e90-86c6-86599b6f3861	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-417-29	69168041729	8 CAPSULE in 1 BLISTER PACK (69168-417-29)	8 capsule	2020-11-11	0000-00-00	No	No	Current
69168-417-51	69168041751	2 BLISTER PACK in 1 CARTON (69168-417-51) / 10 CAPSULE in 1 BLISTER PACK	2 blister pack	2020-11-11	0000-00-00	No	No	Current
69168-417-93	69168041793	12 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
438 - Daytime Nighttime Cold and Flu	Allegiant Health	2022-05-19	HUMAN OTC DRUG LABEL	6
417- Daytime Cold and Flu	Allegiant Health	2020-11-16	HUMAN OTC DRUG LABEL	3