Daytime Nighttime Cold Flu Relief

Product NDC: 81522-901
11-digit product format: 815220901
Labeler code: 81522
Product ID: 81522-901_710304bf-086d-4773-897f-656cf431f16d
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCL
Dosage form: KIT
Labeler: FSA Store Inc. (Caring Mills)
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-31
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
8d7bb31b-a47d-4252-a0a7-79d286179fb9	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
81522-901-48	Daytime Nighttime Cold Flu Relief	1 in 1 KIT	KIT	1		12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81522-901	DAYTIME NIGHTTIME COLD FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [FSA STORE INC. (CARING MILLS)]	11	Current NDC, 1 package rows	20241206_8d7bb31b-a47d-4252-a0a7-79d286179fb9.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 131 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cold and Flu Nighttime Severe, 24-7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store products, Inc.	05d0410f-164e-e7ee-e063-6394a90a2aaa	2024-12-16	Warnings	Exact identifier application number: M012
tussin dm max daytime nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN	CVS Pharmacy	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	2024-12-16	Warnings	Exact identifier application number: M012
Leader Childrens Multi Symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	169ff9cf-fcf5-46a6-b460-259421f2ec07	2024-12-16	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012
CVS Vapor Steam	CAMPHOR (SYNTHETIC)	CVS	49da2c40-afc5-5770-e054-00144ff88e88	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Daytime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	The Kroger Company	e428dd83-c538-2a92-e053-2a95a90a0e16	2024-12-13	Warnings	Exact identifier application number: M012
Kroger Nighttime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	The Kroger Company	e46291c7-6f4d-46a2-e053-2a95a90a80a1	2024-12-13	Warnings	Exact identifier application number: M012
Foster and Thrive Childrens Allergy Relief	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	7eaba464-5cdb-4bd4-b272-38fa108658d5	2024-12-13	Warnings	Exact identifier application number: M012
SUDAFED OM Sinus Severe Original	OXYMETAZOLINE HYDROCHLORIDE	Kenvue Brands LLC	1d089074-3969-ce6e-e063-6294a90aa70c	2024-12-12	Warnings	Exact identifier application number: M012
RIGHT REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc	b4fc014c-7c5f-46a4-bf13-57103b6fa018	2024-12-11	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride 25mg	DIPHENHYDRAMINE HYDROCHLORIDE 25MG	Strive Pharmaceuticals Inc	b440eb2e-4de9-2b65-e053-2995a90abda8	2024-12-11	Warnings	Exact identifier application number: M012
Meijer Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	6933ca9d-a32d-d856-e053-2a91aa0a408e	2024-12-10	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Meijer Distribution Inc.	826b5c0d-7a75-bbf0-e053-2a91aa0aebd6	2024-12-10	Warnings	Exact identifier application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETIC	MENTHOL	Ricola USA Inc.	09141018-37ba-4c93-9051-1ed129c448c1	2024-12-10	Warnings	Exact identifier application number: M012
Original Herb Cough Drops	MENTHOL	Ricola USA Inc.	6ac9d95b-f6b9-4515-b126-697f8f839612	2024-12-10	Warnings	Exact identifier application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPS	MENTHOL	Ricola USA Inc.	989d1529-2875-47bf-81df-65494d62be7a	2024-12-10	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	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
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	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1086997	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1086997	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
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	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1086997	APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SY	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	8d7bb31b-a47d-4252-a0a7-79d286179fb9	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81522-901-48	81522090148	1 KIT in 1 KIT (81522-901-48) * 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	2023-01-31	No	No	Current