Daytime Nighttime Cold and Flu Relief Combo Pack

Product NDC: 69168-438
11-digit product format: 691680438
Labeler code: 69168
Product ID: 69168-438_e50f1230-f2bc-4bf1-8488-c1d8525e368c
Type: HUMAN OTC DRUG
Nonproprietary name: Daytime Nighttime Cold and Flu
Dosage form: KIT
Labeler: Allegiant Health
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-05-20
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 Nighttime Cold and Flu Relief Combo Pack
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1086997	Internal RxNorm lookup
1094549	Internal RxNorm lookup
2634564	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
fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	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	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
69168-418-86	Daytime Nighttime Cold and Flu Relief Combo Pack	12 in 1 BLISTER PACK	CAPSULE	12	325 mg	6
69168-418-86	Daytime Nighttime Cold and Flu Relief Combo Pack	1 in 1 CARTON	CAPSULE		6.25 mg	6
69168-438-15	Daytime Nighttime Cold and Flu Relief Combo Pack	1 in 1 CARTON	KIT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-438	DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK (DAYTIME NIGHTTIME COLD AND FLU) KIT [ALLEGIANT HEALTH]	5	Current NDC, Legacy NDC, 5 package rows	20231020_fa7ed5db-4da7-46b4-a08d-1d79cb7a5674.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 163 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Cold and Flu Daytime Honey	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Kroger	10b0fa3d-d6b2-272a-e063-6394a90a1205	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Plus Multi Symptom Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	dd967cfb-96b4-4cdc-82e2-a4838001c9e3	2024-05-08	Warnings	Exact identifier application number: M012
Childrens Wal Tap Elixer Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Walgreens	3f438f28-d1ad-44da-a573-f1b0824b051c	2024-05-08	Warnings	Exact identifier application number: M012
Cough Cold and Sore Throat Childrens	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	400a0998-e276-4c8d-9b41-145b1b405fff	2024-05-08	Warnings	Exact identifier application number: M012
Mucus Congestion and Cough Relief Childrens	DEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCI	Walgreens	19cd2409-d56b-4319-833c-eacc7dc498c1	2024-05-08	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger	10b12f0e-dba7-fd71-e063-6294a90a42c1	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATE	Kroger	10b15337-b9c5-4dc8-e063-6394a90ac056	2024-05-06	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Kroger	1014da86-3a0e-136f-e063-6294a90ac931	2024-05-04	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Haleon US Holdings LLC	eaa10aed-5b1e-48bf-bc05-7a5638851daf	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	e35cb719-9e7d-4b2b-81a4-29e147dd74fa	2024-05-03	Warnings	Exact identifier application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCL	Haleon US Holdings LLC	09e20842-2b75-43b9-ae5f-3515b35e655b	2024-05-03	Warnings	Exact identifier application number: M012
Cold and Flu Relief	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	Family Dollar (FAMILY WELLNESS)	f958d8ba-ede9-4b1a-8317-2404b68a9129	2024-05-03	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	WinCo Foods, LLC	fab57d70-ba54-416f-9f14-b64d2238ea16	2024-05-03	Warnings	Exact identifier application number: M012
Tussin CF Non Drowsy Multi Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	WinCo Foods, LLC	8ee27600-4f8e-406a-8ea3-eade691448f6	2024-05-03	Warnings	Exact identifier application number: M012
SanaTos Children Cough and Congestion Cherry	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Pharmadel LLC	60437d86-9e13-8d8a-e053-2991aa0a2317	2024-05-02	Warnings	Exact identifier application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Haleon US Holdings LLC	0b41da13-18a1-4987-ae43-1319bfa27484	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a	2024-05-01	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	QUALITY CHOICE (Chain Drug Marketing Association)	dbfb8971-a122-4a97-a665-e3f0d494876e	2024-05-01	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	P & L Development, LLC	c08b150c-d821-466c-8521-f77535d6af1e	2024-04-30	Warnings	Exact identifier application number: M012
childrens allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Walgreen Company	7848bb09-2af8-47f6-b32d-96635a750a55	2024-04-29	Warnings	Exact identifier application number: M012

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-417-93	69168041793	12 in 1 BLISTER PACK						Historical
69168-418-86	69168041886	12 in 1 BLISTER PACK						Historical
69168-438-15	69168043815	1 KIT in 1 CARTON (69168-438-15) * 2 BLISTER PACK in 1 CARTON (69168-417-93) / 12 CAPSULE in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON (69168-418-86) / 12 CAPSULE in 1 BLISTER PACK	1 kit	2022-05-20	0000-00-00	No	No	Current