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 158 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Herbal Flavor Menthol Cough Drops	HERBAL FLAVOR MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb848b6-3dec-5b5f-e063-6394a90aea14	2024-08-02	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb8927b-22c5-2ca3-e063-6294a90aa563	2024-08-02	Warnings	Exact identifier application number: M012
No Drip Severe Anefrin Nasal	0.05% OXYMETAZOLINE HCL	Walgreens Company	c126e969-56f3-47b4-a011-02ff150eccb8	2024-08-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HCL	A-S Medication Solutions	0e81a937-59e5-4869-8ffb-c758fb37230d	2024-07-23	Warnings	Exact identifier application number: M012
WesTussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Westminster Pharmaceuticals, LLC	68a0cd44-3fdd-430e-af1a-498d4415ab78	2024-07-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Lil' Drug Store Products, Inc.	edc244d6-eb0b-d3c9-e053-2a95a90a2622	2024-07-22	Warnings	Exact identifier application number: M012
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9	2024-07-22	Warnings	Exact identifier application number: M012
CareOne Childrens Allergy Relief	DIPHENHYDRAMINE HCL	American Sales Company	bb78ef2c-4f42-4e8f-b38d-f9b2965a384b	2024-07-19	Warnings	Exact identifier application number: M012
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	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