Night Time Cold and Flu

Product NDC: 72476-998
11-digit product format: 724760998
Labeler code: 72476
Product ID: 72476-998_2778d8c6-a305-1d25-e063-6294a90a3073
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate, Phenylephrine hydrochloride
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Retail Business Services, LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-03-18
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: 2026-12-31
Current FDA listing: Yes

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72476-998-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72476-998-14	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72476-998-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72476-998-14	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72476-998-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72476-998-14	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72476-998-14	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72476-998-14	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72476-998-14	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	72476-998-14	`8dfbde2a14a4…`	`c9ff85d89658…`

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: Night Time Cold and Flu
Listing expiration: 2026-12-31

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
1297288	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
fc8c70d6-6be5-4f12-84b0-125fc82149ec	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72476-998-14	2024-11-22	C162847	48780-1	ba0f9c33-3030-a910-e053-dadaa90a0b85	Night Time Cold & Flu
72476-998-14	2021-01-29	C162847	48780-1	ba0f9c33-3030-a910-e053-dadaa90a0b85	Night Time Cold & Flu

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72476-998-14	Night Time Cold and Flu	2 in 1 CARTON	CAPSULE, LIQUID FILLED	2		2
72476-998-14	Night Time Cold and Flu	8 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	8		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72476-998	NIGHT TIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RETAIL BUSINESS SERVICES, LLC]	2	Current NDC, Legacy NDC, 2 package rows	20241123_fc8c70d6-6be5-4f12-84b0-125fc82149ec.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 5 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MUCUS RELIEF	GUAIFENESIN	Geri-Care Pharmaceuticals, Corp	5afb242f-fac9-dc81-e063-6394a90a8448	2026-08-27	Warnings	Exact identifier application number: M012
daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Amazon.com Services LLC	6de619d3-0ab0-43e7-8dac-7bbd5368ac65	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Mucus Relief Severe Congestion and Cough and Nighttime Cold and Flu Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI	Walgreens	366ddac8-9e8a-41bd-a7f7-48213485a5f8	2026-08-27	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	37896933-3ed3-457f-8a32-ee0d784a19e8	2026-08-27	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	298e9164-e378-4b39-a944-bfc8f8baa4de	2026-08-27	Warnings	Exact identifier application number: M012
DayTime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum Strength	DAYTIME ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, NIGHTTIME ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Walgreens	3b4b3b04-eff9-4e06-8b37-f6729671d07f	2026-08-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu mini Softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	dfb0fe2e-b0c7-409a-bd1a-fd12485665ba	2026-08-26	Warnings	Exact identifier application number: M012
Nighttime Severe Cold and Flu Maximum Strength mini softgels	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Shield Pharmaceuticals Corp	70c5517d-be4e-4317-b4f4-df660c71c699	2026-08-26	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	c1f9ec75-7eb2-405c-8cdc-097cbf2cf87d	2026-08-26	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	5b95905e-b729-4caf-921a-fc4ef815289c	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	c88e93d4-66b6-4327-b9e5-0e0a95a18d66	2026-08-25	Warnings	Exact identifier application number: M012
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4fff664b-4ff0-4007-95ab-cb273807b9b4	2026-08-25	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	Walgreen Company	7d972559-6184-476b-9cbf-1bc5663ea00d	2026-08-24	Warnings	Exact identifier application number: M012
Cold, Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Meijer Distribution, Inc.	9be8437c-6053-4ed4-bdd2-97f556b5289e	2026-08-24	Warnings	Exact identifier application number: M012
Extra Strength Tylenol Cold Plus Flu Multi-Symptom Day Night	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	594f515c-b369-816d-e063-6294a90a59a1	2026-08-21	Warnings	Exact identifier application number: M012
DG HEALTH MULTI SYMPTOM SEVERE COLD	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, LLC	47ddbb0d-0823-4817-9c56-e7fff77d601c	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	DOLGENCORP, LLC	5be4e730-3cd6-414e-a23b-f6cad8088750	2026-08-21	Warnings	Exact identifier application number: M012
Mucus Relief DM Cough Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	Cardinal Health 110, LLC. DBA Leader	6304a581-9238-4539-b157-293fc05c173e	2026-08-21	Warnings	Exact identifier application number: M012
COMBINATION PACK HyVee Daytime and Nighttime Severe Cold and Flu SOFTGEL - 24ct	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	HyVee Inc	82ead335-d38e-40c3-8031-222bf985a302	2026-08-20	Warnings	Exact identifier application number: M012
HyVee Nighttime Severe Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	HyVee Inc	49818610-bf4a-fb86-e063-6294a90ae598	2026-08-20	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
1297288	acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2
1297288	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2
1297288	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	fc8c70d6-6be5-4f12-84b0-125fc82149ec	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72476-998-14	72476099814	2 BLISTER PACK in 1 CARTON (72476-998-14) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	2 blister pack	2019-03-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Night Time Cold & Flu	Retail Business Services, LLC \| Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.	2024-11-21	HUMAN OTC DRUG LABEL	2