nitetime cold and flu

Product NDC: 41250-335
11-digit product format: 412500335
Labeler code: 41250
Product ID: 41250-335_d30b1a85-a76e-486c-b145-cac3cda64450
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Meijer Distribution Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-09-21
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes: 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]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	41250-335	41250-335-38	D	Discontinued by firm		2026-08-03
excluded package	package	41250-335	41250-335-43	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	41250-335-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	41250-335-38	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-335-43	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	41250-335-38	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-335-43	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	41250-335-38	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-335-43	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	41250-335-38	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-335-43	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	41250-335-38	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-335-43	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	41250-335-38	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-335-43	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	41250-335-38	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-335-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	41250-335-38	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-335-43	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	41250-335-38	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-335-43	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	41250-335-38	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-335-43	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	41250-335-38	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-335-43	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	41250-335-38	`557ba5c1ecfa…`	`9c80585c8c6e…`

Additional Listing Data#

Finished product: Yes
Brand name base: nitetime cold and flu
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043400	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
dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	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	SPL version
41250-335-38	nitetime cold and flu	296 mL in 1 BOTTLE	SOLUTION	296	9
41250-335-40	nitetime cold and flu	355 mL in 1 BOTTLE	SOLUTION	355	9
41250-335-43	nitetime cold and flu	473 mL in 1 BOTTLE	SOLUTION	473	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41250-335	NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]	9	Current NDC, Legacy NDC, 3 package rows	20241218_dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Family Dollar Services Inc	ce590997-3cae-4f22-ac39-2b14d39494bc	2026-07-30	Warnings	Exact identifier application number: M012
Robitussin Direct Cough	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	70c9556b-063a-4fb3-96f6-1d4ffa495ed4	2026-07-30	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	a302e341-1c00-4c3d-b71f-c4c0b307aa67	2026-07-29	Warnings	Exact identifier application number: M012
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreens	4c737cd6-fe56-4cef-887c-cd6cf83b254c	2026-07-29	Warnings	Exact identifier application number: M012
ROBITUSSIN LONG-ACTING COUGHGELS	DEXTROMETHORPHAN HYDROBROMIDE	Haleon US Holdings LLC	472c5c1f-eb5a-444b-a17e-f0d71007fb15	2026-07-29	Warnings	Exact identifier application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Meijer Distribution Inc	3a33c6ce-aada-4099-8c61-49c86c0fc1a8	2026-07-29	Warnings	Exact identifier application number: M012
Tussin DM Max Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	668c92ce-6c1f-4ab3-b0dd-822b0768cb5e	2026-07-29	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	702f9786-7ce9-43e4-921d-e1db09612127	2026-07-28	Warnings	Exact identifier application number: M012
LoHist-D	CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL	Larken Laboratories, Inc.	efaa354e-c25c-405b-9d30-001c2796978c	2026-07-28	Warnings	Exact identifier application number: M012
NIGHTTIME SEVERE COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d1115a55-35cd-4f20-8872-f42983a5ebcd	2026-07-28	Warnings	Exact identifier application number: M012
TUSSIN	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Safeway	a5e2bda4-2da6-4c20-855d-2888dadf0c3a	2026-07-28	Warnings	Exact identifier application number: M012
DM Maximum	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	f6029b04-e681-40fc-be4f-14091b76dd4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	CVS PHARMACY	e958eef1-8aae-4365-ac64-95a9e8e7e0f2	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP INC	38400854-27fa-e291-e063-6294a90a5c4e	2026-07-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	65802aa7-64e7-4435-ad6b-65895fba17ce	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	Walgreen Company	0a48f650-ad2a-4105-9ff4-2bc4d94b46d3	2026-07-27	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	84202ebe-97b6-4be2-bb09-7f2729303f96	2026-07-27	Warnings	Exact identifier application number: M012
Daytime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	8d41defe-8120-4cbb-b42e-c805cc5a794b	2026-07-24	Warnings	Exact identifier application number: M012
Childrens Benadryl ALLERGY	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	fc9181b9-c92d-493e-8d7c-4a4239c6c092	2026-07-24	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Prodose, Inc.	3afc88c7-388a-dbd9-e063-6294a90a4faf	2026-07-24	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	9
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	9
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	9
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	9
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41250-335-38	41250033538	296 mL in 1 BOTTLE	296 ml					Historical
41250-335-40	41250033540	355 mL in 1 BOTTLE (41250-335-40)	355 ml	2012-10-24	0000-00-00	No	No	Current
41250-335-43	41250033543	473 mL in 1 BOTTLE	473 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Meijer Distribution, Inc. NiteTime Cold & Flu Drug Facts	Meijer Distribution Inc	2024-10-11	HUMAN OTC DRUG LABEL	9