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 17 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flu HBP Maximum Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Rite Aid Corporation	f1a4ee57-33a3-4791-a769-b208b38acb72	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	c499574c-f32b-4608-bf8b-51ad44e35725	2026-07-13	Warnings	Exact identifier application number: M012
Good NeighborChildrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	f442c61b-7d2c-401c-b862-acbe2282927b	2026-07-13	Warnings	Exact identifier application number: M012
Sanatos	MENTHOL	Pharmadel LLC	5683b099-f029-2d08-e063-6394a90ad482	2026-07-13	Warnings	Exact identifier application number: M012
Cold and Flu Relief Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f673cdeb-4f8b-46b4-be92-c725d74abc55	2026-07-13	Warnings	Exact identifier application number: M012
Cold Multi-Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	e4fca5ba-2d45-4c38-b0fd-297159d1705a	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Sugar Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	AMERISOURCE BERGEN	0269c0fd-0d8f-4264-9025-d4dcb3c45c60	2026-07-13	Warnings	Exact identifier application number: M012
Propolis Cooling Relief Cherry Cough Drops	MENTHOL, UNSPECIFIED FORM	Beekeeper's Naturals USA Inc	7087566d-f24a-4508-aa25-7f42d055c43e	2026-07-13	Warnings	Exact identifier application number: M012
Sinus Pressure and Congestion Relief	DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Rite Aid Corporation	35bcf263-3296-4d9c-84c0-146a173d6e87	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Childrens Cough Relief Cherry Flavor	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	a8e2fd43-b801-41ae-8d79-8ecf4a771543	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor No Drip Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	7872aadd-b23c-431f-8048-24eece25ca2d	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Dye Free Adult Tussin DM Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	AMERISOURCE BERGEN	404a3521-8340-4476-a068-0e69cd0e514f	2026-07-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8a8bd1e3-f3ce-484b-a98c-2cf3f03f1ab5	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Long Acting Cough Adult Tussin	DEXTROMETHORPHAN HBR	AMERISOURCE BERGEN	df3c76bd-bd5b-42d7-a5f1-560fd3cba646	2026-07-13	Warnings	Exact identifier application number: M012
Good Neighbor Adult Tussin Mucus and chest congestion	GUAIFENESIN	AMERISOURCE BERGEN	97e9cd18-dd55-4a26-80e3-4c17b9e1a1e8	2026-07-13	Warnings	Exact identifier application number: M012
GOOD NEIGHBOR PHARMACY No Drip Nasal Mist	OXYMETAZOLINE HYDROCHLORIDE	AMERISOURCE BERGEN	a217ca8a-1c00-4816-bc26-cc0f71c80c90	2026-07-13	Warnings	Exact identifier application number: M012
Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	1ddc04fb-069c-44fe-814b-ba4f503c4be0	2026-07-10	Warnings	Exact identifier application number: M012
COUGH DROPS- menthol granule	MENTHOL GRANULE	Anhui Jiuhe Health Industry Co., Ltd	5351b943-5830-e4e7-e063-6394a90a5b66	2026-07-10	Warnings	Exact identifier application number: M012
ValuMeds Nasal Decongestant PE Phenylephrine	PHENYLEPHRINE HYDROCHLORIDE	Cabinet Health P.B.C.	3f284420-87c1-4c17-99e5-bc569bf9d45f	2026-07-10	Warnings	Exact identifier application number: M012
Severe Congestion and Cough Multi-Symptom Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS Pharmacy	707eb066-cdfc-444b-833a-9d6d133d48e4	2026-07-10	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