Daytime Nighttime Cold Flu Relief

Product NDC: 67091-393
11-digit product format: 670910393
Labeler code: 67091
Product ID: 67091-393_98617b2b-6315-46e7-ae8b-577a3bcead16
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL
Dosage form: KIT
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-10-29
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 Nighttime Cold Flu Relief
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
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
6bd2b8fd-2023-413b-8988-a47d2058dc85	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
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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
76633df9-0d59-4b88-03ed-21dee1b966f8	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
67091-393-48	Daytime Nighttime Cold Flu Relief	1 in 1 KIT	KIT	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-393	DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WINCO FOODS, LLC]	6	Current NDC, Legacy NDC, 1 package rows	20240504_6bd2b8fd-2023-413b-8988-a47d2058dc85.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 63 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zicam Extreme Congestion Relief	OXYMETAZOLINE HYDROCHLORIDE	Church & Dwight Co., Inc.	ccada339-656c-a461-e053-2a95a90a3479	2025-12-31	Warnings	Exact identifier application number: M012
ED A-HIST DM	DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	e0e2b117-62bc-4132-9f7c-fe2a912052b1	2025-12-31	Warnings	Exact identifier application number: M012
Bio-Z-Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Advanced Generic Corporation	05e70eab-1467-4b09-991e-ef03f222e021	2025-12-31	Warnings	Exact identifier application number: M012
Altipres-B	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Alternative Pharmacal Corporation	fd00c41d-0580-4177-afaa-60bb12ca5a09	2025-12-31	Warnings	Exact identifier application number: M012
Ninjacof-D	CHLOPHEDIANOL HYDROCHLORIDE, PYRILAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	Centurion Labs, LLC	5188aa20-41f1-4998-81e1-f4de055874bc	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	4743e562-1217-50ab-e063-6394a90af88d	2025-12-31	Warnings	Exact identifier application number: M012
Llorens Care Tussin	GUAIFENESIN	Llorens Pharmaceutical International Division, Inc.	474459c1-bfd7-dec7-e063-6394a90ac18d	2025-12-31	Warnings	Exact identifier application number: M012
Geri Care Tussin CF Max	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICAL CORP	4744669c-7f33-e35f-e063-6394a90a79b7	2025-12-31	Warnings	Exact identifier application number: M012
Geri-Tussin	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	65545ca3-4e93-4b59-9e17-4742e086e8e7	2025-12-31	Warnings	Exact identifier application number: M012
GeriCare Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	GERI-CARE PHARMACEUTICALS, CORP	47451cd8-7aab-90e2-e063-6394a90ad1b7	2025-12-31	Warnings	Exact identifier application number: M012
Curewell Tussin	GUAIFENESIN	RMT HEALTH LLC	47455587-5074-e70d-e063-6294a90a78bb	2025-12-31	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	Bestco Inc.	77e25027-3c96-21fa-e053-2991aa0a1f31	2025-12-31	Warnings	Exact identifier application number: M012
Puregen Labs Allergy Relief	DIPHENHYDRAMINE HCL	Advanced Rx LLC	4745d4f9-bbdf-a4a6-e063-6294a90a15b2	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2a46ea9b-29e9-5197-e063-6394a90abc73	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77e50410-306d-b2fb-e053-2a91aa0af3c5	2025-12-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	e086a6d2-f664-454e-9524-f656bfbf45df	2025-12-31	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Bestco Inc.	77f45efb-8ee0-1186-e053-2991aa0a9884	2025-12-31	Warnings	Exact identifier application number: M012
Conex Pediatric	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a46af43-ef36-e14e-e063-6394a90a8285	2025-12-31	Warnings	Exact identifier application number: M012
Conex	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL	Llorens Pharmaceutical International Division	2a343656-ac6d-8b20-e063-6294a90ab319	2025-12-31	Warnings	Exact identifier application number: M012
Dologesic NF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	Llorens Pharmaceutical International Division	974fc0d5-7a99-46fb-af38-b91240f728fa	2025-12-31	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	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
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	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
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	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	6bd2b8fd-2023-413b-8988-a47d2058dc85	8
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	6bd2b8fd-2023-413b-8988-a47d2058dc85	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-393-48	67091039348	1 KIT in 1 KIT (67091-393-48) * 16 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 32 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	1 kit	2021-10-29	0000-00-00	No	No	Current