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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
good sense allergy	DIPHENHYDRAMINE HCL	L. Perrigo Company	bf5039a0-2109-41a2-84a9-b5167d0a93da	2026-07-22	Warnings	Exact identifier application number: M012
Congestion and Headache	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	432c3ec4-7595-4213-94e3-ce41af91804e	2026-07-21	Warnings	Exact identifier application number: M012
SKAPEMED ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a208a1f-f6e8-0b4a-e063-6294a90a10c8	2026-07-21	Warnings	Exact identifier application number: M012
SERYNTH FAST RELIEF NASAL	NAPHAZOLINE HCL 0.05% FAST RELIEF NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4abdc0-aded-1b8a-e063-6394a90a9b56	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d0c03-7d8f-76cb-e063-6394a90a938c	2026-07-21	Warnings	Exact identifier application number: M012
DERMFREE ORIGINAL NASAL	NAPHAZOLINE HCL 0.05%ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d3a2b-a4ed-c736-e063-6394a90a96df	2026-07-21	Warnings	Exact identifier application number: M012
Severe Cough and Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CVS PHARMACY	791eaac1-ddb5-40e2-9040-52dfadc30e06	2026-07-21	Warnings	Exact identifier application number: M012
DRx Choice DAYTIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Raritan Pharmaceuticals Inc.	9ab47b10-b1ed-4ae1-94e8-09d50e952bb0	2026-07-21	Warnings	Exact identifier application number: M012
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	P & L Development, LLC	17639c3b-5d36-41f5-bd0d-da29075abd09	2026-07-21	Warnings	Exact identifier application number: M012
NATUHEAL ORIGINAL NASAL	NAPHAZOLINE HCL 0.05% ORIGINAL NASAL	Jiangxi Yudexi Pharmaceutical Co., LTD	4a470b9e-c83f-fb20-e063-6294a90a2f13	2026-07-20	Warnings	Exact identifier application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels Day	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	1c444202-19e9-8d04-e063-6394a90a9294	2026-07-20	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART	COUGH DROPS HONEY LEMON	DISCOUNT DRUG MART	5565a581-e2b5-81a5-e063-6394a90af409	2026-07-20	Warnings	Exact identifier application number: M012
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	40e0b17a-5704-4203-8f0a-11b2fcf81f8f	2026-07-17	Warnings	Exact identifier application number: M012
Equate Daytime Vapor Ice Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	WALMART INC.	ee1ef41d-b8be-42f3-9918-ccf1c0a80241	2026-07-17	Warnings	Exact identifier application number: M012
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	879a7804-f3d4-4a3d-bc92-b473499d6c95	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	95007785-ddf6-4386-af5f-84dac1066b40	2026-07-17	Warnings	Exact identifier application number: M012
BEST CHOICE No Drip	ALLERGY SINUS	BEST CHOICE (VALU MERCHANDISERS COMPANY)	d5f95b56-8201-4d97-82ab-e23761bfe720	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice Ultra Fine Mist	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	7d19fdba-35b0-424a-ba11-315521d3256d	2026-07-17	Warnings	Exact identifier application number: M012
Best Choice Maximum Strength	OXYMETAZOLINE HYDROCHLORIDE	BEST CHOICE (VALU MERCHANDISERS COMPANY)	badb15ac-91e8-4962-96f5-beb250977560	2026-07-17	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	0839c07b-f692-4af1-85b8-da60fb281d49	2026-07-17	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