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: 2027-12-31
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		2026-10-21
excluded package	package	41250-335	41250-335-43	D	Discontinued by firm		2026-10-21

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…`

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: nitetime cold and flu
Listing expiration: 2027-12-31

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 157 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	445e49a2-6ed0-434c-aaea-3ce14bc7df59	2024-08-12	Warnings	Exact identifier application number: M012
Allergy Multi Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	d49b42ad-0ae0-48c9-adba-5fc2ced97764	2024-08-12	Warnings	Exact identifier application number: M012
RYMED	DEXCHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDE	EDWARDS PHARMACEUTICALS, INC.	c1d6e914-74cc-4cdf-9587-7eaaa4a386e5	2024-08-12	Warnings	Exact identifier application number: M012
WesTussin DM NF	WESTUSSIN DM NF	Westminster Pharmaceuticals, LLC	4e0f9f97-a31c-41ac-9d6c-d81efd20fcef	2024-08-08	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Severe Congestion and Pain	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	2f2a2864-af11-4240-bdad-a54aca58d01b	2024-08-07	Warnings	Exact identifier application number: M012
Cold plus Flu Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0199aea2-a9c1-4c9d-8786-28b9dadc832e	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	32d1ce6e-2617-4b50-a9e6-2e1941465dff	2024-08-07	Warnings	Exact identifier application number: M012
Sinus Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	07362db5-a372-4463-af8b-06e8783ca865	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Flu Severe PE	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	1fb11d90-48bf-4baa-9b3a-5d64d81e3a06	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Sinus Pressure Pain and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	574774b2-9813-4799-9cd4-27e296dd8584	2024-08-07	Warnings	Exact identifier application number: M012
Cold Max Day and NIght	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	a92bcefb-ba29-4b3f-a60b-b4476ca8cf04	2024-08-07	Warnings	Exact identifier application number: M012
Sinus plus Headache	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	778f1f5a-fd04-456f-90d0-998b93e774a5	2024-08-07	Warnings	Exact identifier application number: M012
Head Congestion plus Mucus PE	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	990f3232-bc75-45cf-8a50-cd7861d83f98	2024-08-07	Warnings	Exact identifier application number: M012
Mucus Relief Cold and Flu All in One	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	0f5f25c6-7389-4285-b8d5-463cb7b6fcc4	2024-08-07	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE	Care One (Retail Business Services, LLC.)	a9a5b39d-b4c8-414e-8fe7-4c0601f75197	2024-08-05	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	b94feeb6-f33f-410d-a9b0-776b1ccf34a9	2024-08-04	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	American Health Packaging	4cd8aee3-5522-434b-a1b1-9591bed3e9a6	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	8632a655-7f5b-450f-95fa-62478a174e9c	2024-08-04	Warnings	Exact identifier application number: M012
Guaifenesin DM	GUAIFENESIN AND DEXTROMETHORPHAN	American Health Packaging	990906b3-c566-4f35-923c-060202ba48e0	2024-08-04	Warnings	Exact identifier application number: M012
Honey Lemon Flavor Cough Drops	HONEY LEMON FLAVOR MENTHOL	WHOLE FOODS MARKET, INC.	1eb7abdc-061f-0e18-e063-6294a90a3a65	2024-08-02	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