Nite time Severe Cold and Flu

Product NDC: 41250-877
11-digit product format: 412500877
Labeler code: 41250
Product ID: 41250-877_908a3106-2529-4252-a766-14b53d39ac84
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate, Phenylephrine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-08-01
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [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: 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: Nite time Severe Cold and Flu
Brand name suffix: Maximum Strength
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	10 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1
PHENYLEPHRINE HYDROCHLORIDE	5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	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
1546881	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
f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	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
41250-877-08	Nite time Severe Cold and FluMaximum Strength	2 in 1 CARTON	TABLET, FILM COATED	2		16
41250-877-08	Nite time Severe Cold and FluMaximum Strength	12 in 1 BLISTER PACK	TABLET, FILM COATED	12		16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NITE TIME SEVERE COLD AND FLU DAMAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-877	NITE TIME SEVERE COLD AND FLU MAXIMUM STRENGTH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [MEIJER DISTRIBUTION INC]	15	Current NDC, Legacy NDC, 2 package rows	20250126_f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13.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 160 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	Warnings	Exact identifier application number: M012
Family Wellness Effervescent Cold Relief Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Family Dollar Services, Inc.	4e13511b-fbb5-2523-e054-00144ff88e88	2024-07-03	Warnings	Exact identifier application number: M012
Nighttime Cherry Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	TARGET CORPORATION	1c3f6cbf-a00d-45b9-e063-6394a90a797c	2024-07-02	Warnings	Exact identifier application number: M012
Cold Terminator Cold Relief	PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Wildman Business Group	e8538d9c-f9ba-40b1-b60f-f57921f39b64	2024-07-01	Warnings	Exact identifier application number: M012
Nighttime Severe Honey Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1c02e465-8750-a088-e063-6394a90a8efb	2024-06-29	Warnings	Exact identifier application number: M012
ACTIDOM DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	0166322e-7dbb-4658-a5c5-1d0525bb7655	2024-06-28	Warnings	Exact identifier application number: M012
ACTINEL DM	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	ACTIPHARMA, LLC	16660d82-524b-42ca-8581-48237caa13b2	2024-06-28	Warnings	Exact identifier application number: M012
PurgenLabs Acetaminophen	ACTAMINOPHEN	Advanced Rx LLC	915c4608-af1b-4119-8291-4ce9fd701d76	2024-06-28	Warnings	Exact identifier application number: M012
Daytime Ultra Concentrated Cold and Flu	ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL	TARGET CORPORATION	1bc90b2f-612c-e977-e063-6294a90a40b4	2024-06-26	Warnings	Exact identifier application number: M012
Halls Mentholyptus	MENTHOL	Mondelez Global LLC	f5292c5b-5608-4e13-afc2-4f3d7133da88	2024-06-25	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	75638f29-7f2a-46b0-b8a0-e87bc7d6eba1	2024-06-25	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant PE	PHENYLEPHRINE HYDROCHLORIDE	A-S Medication Solutions	5396a9cf-16eb-4628-9432-f49c67ffe2ce	2024-06-25	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Liquid	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	TARGET CORPORATION	130ca5f1-2951-ec6f-e063-6394a90a754f	2024-06-24	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE	TARGET CORPORATION	08fd1513-30ab-15da-e063-6394a90ab57d	2024-06-21	Warnings	Exact identifier application number: M012
Daytime Severe and Nighttime Severe cold and flu	DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	0c0caa59-0637-bc33-e063-6294a90ae244	2024-06-21	Warnings	Exact identifier application number: M012
Halls Strawberry	MENTHOL	Mondelez Global LLC	de401eb4-3282-4298-8a51-15d268253464	2024-06-21	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreens	e4515d0e-c12b-40cd-8218-6d91476cfebd	2024-06-21	Warnings	Exact identifier application number: M012
SUDOGEST	PSEUDOEPHEDRINE HCL	A-S Medication Solutions	1811199f-bf88-475f-8f94-b372db4bead3	2024-06-20	Warnings	Exact identifier application number: M012
Theraflu Severe Cold Relief Soft Chews	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	91dbb541-6a86-4803-a1fe-1bf61b457c34	2024-06-19	Warnings	Exact identifier application number: M012
Tukol Max Action Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	aedce1f9-4902-4c51-92e0-6056196394c2	2024-06-14	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
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1546881	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Tablet	PSN	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16
1546881	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Tablet	SCD	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16
1546881	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Tablet	SY	f8f84be1-e3b1-4e93-8e1c-ee93e1f4af13	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-877-08	41250087708	2 BLISTER PACK in 1 CARTON (41250-877-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2015-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer 44-677	Meijer Distribution Inc \| LNK International, Inc.	2026-07-02	HUMAN OTC DRUG LABEL	17