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 158 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Menthol Cough Drops	MENTHOL COUGH DROPS	WHOLE FOODS MARKET, INC.	1eb8927b-22c5-2ca3-e063-6294a90aa563	2024-08-02	Warnings	Exact identifier application number: M012
No Drip Severe Anefrin Nasal	0.05% OXYMETAZOLINE HCL	Walgreens Company	c126e969-56f3-47b4-a011-02ff150eccb8	2024-08-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	90e0426b-654f-4bcd-8b1d-cf56d1fc0c68	2024-07-27	Warnings	Exact identifier application number: M012
nasal decongestant	OXYMETAZOLINE HCL	A-S Medication Solutions	0e81a937-59e5-4869-8ffb-c758fb37230d	2024-07-23	Warnings	Exact identifier application number: M012
WesTussin DM	DEXCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Westminster Pharmaceuticals, LLC	68a0cd44-3fdd-430e-af1a-498d4415ab78	2024-07-23	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL 25 MG	Lil' Drug Store Products, Inc.	edc244d6-eb0b-d3c9-e053-2a95a90a2622	2024-07-22	Warnings	Exact identifier application number: M012
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1f3eeb6c-4c44-4e2a-ad72-12c95e6589c9	2024-07-22	Warnings	Exact identifier application number: M012
CareOne Childrens Allergy Relief	DIPHENHYDRAMINE HCL	American Sales Company	bb78ef2c-4f42-4e8f-b38d-f9b2965a384b	2024-07-19	Warnings	Exact identifier application number: M012
dg health allergy childrens	DIPHENHYDRAMINE HYDROCHLORIDE	Dolgencorp, LLC	71445443-34bd-4d8c-b9c8-e7c3b8d4c832	2024-07-19	Warnings	Exact identifier application number: M012
basic care childrens allergy relief	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	75b9ee90-ad26-433e-8b90-97441b8d1e15	2024-07-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe Day and Night	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC	9b74dd00-8f84-4fce-b5ea-df886b595326	2024-07-18	Warnings	Exact identifier application number: M012
Cold plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	4872dfdd-0df6-47ae-87f2-8049191cd482	2024-07-18	Warnings	Exact identifier application number: M012
equate allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	b05acd16-21cb-4ee0-afa0-8f7d59166435	2024-07-18	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HCL	Publix Super Markets Inc	cc6e4e26-84f5-4003-b1eb-f0e06d3e294e	2024-07-18	Warnings	Exact identifier application number: M012
childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Kroger Company	10ebc7f8-dc8a-4640-8f87-d0d073998fd5	2024-07-18	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Amerisource Bergen	b173cc2c-7c4c-4f9e-a920-c71bc256ec1e	2024-07-18	Warnings	Exact identifier application number: M012
ALLERGY	CHLORPHENIRAMINE MALEATE	A-S Medication Solutions	b199b5ee-fff3-4746-be68-a04060586f8e	2024-07-18	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	H E B	2d1715b3-b1cf-455d-9909-f6d58c97db40	2024-07-18	Warnings	Exact identifier application number: M012
careone allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	American Sales Company	ed4038fc-ab39-4567-9961-2b390b91b126	2024-07-17	Warnings	Exact identifier application number: M012
Topcare childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	6b784cde-3152-4421-a825-dd1fc601aa7a	2024-07-17	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