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 138 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
careone tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	American Sales Company	6c90fccf-0e6f-43df-9468-d8ece8ded009	2024-11-11	Warnings	Exact identifier application number: M012
good sense night time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	89dc1423-d097-47a8-9025-eab5381cca26	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	10f9627b-edda-422a-b01f-7066f9c98335	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	17c3fe42-3c40-4405-80b7-b3f9e4aa8376	2024-11-11	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	1dd36aa7-f085-4350-8cf2-f9fa29b583e4	2024-11-11	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	a7f9f1d0-7498-461c-b4e8-4c92cf3feae8	2024-11-11	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	bd079f5d-0a38-40e6-9661-e8236c88a24d	2024-11-11	Warnings	Exact identifier application number: M012
GUAIFENESIN DM	GUAIFENESIN AND DEXTROMETHORPHAN	PAI Holdings, LLC dba PAI Pharma	ff970fff-d1a3-4322-83b4-34e361431a1c	2024-11-11	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Topco Associates LLC	e1118592-30ac-4505-9f38-c6d395c4cf5b	2024-11-11	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	624b8029-9fdb-4908-a13b-f9dd75030120	2024-11-11	Warnings	Exact identifier application number: M012
Biofreeze Colorless	MENTHOL	A-S Medication Solutions	cc1cba14-da40-4d7d-b522-b5c648798e96	2024-11-11	Warnings	Exact identifier application number: M012
foster and thrive nighttime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	298b7754-d0d8-496d-9949-4c346cb11e34	2024-11-11	Warnings	Exact identifier application number: M012
leader tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Cardinal Health 110, LLC. dba Leader	b418c10c-528b-4395-944e-af959b639ec2	2024-11-10	Warnings	Exact identifier application number: M012
equaline adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	United Natural Foods, Inc. dba UNFI	f7c753f8-4b12-4797-a599-736d597bc1bc	2024-11-10	Warnings	Exact identifier application number: M012
foster and thrive adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Strategic Sourcing Services LLC	f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7	2024-11-10	Warnings	Exact identifier application number: M012
dg health adult tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Dolgencorp Inc	81f12484-ddf7-49c6-b530-3a81d62ab40d	2024-11-10	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Retail Business Services, LLC	230fa1ea-ae7c-425e-8447-79a90c96ae9e	2024-11-10	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	L. Perrigo Company	cb8a1d81-b1a3-4217-b157-9e5d398f202d	2024-11-09	Warnings	Exact identifier application number: M012
PhysiciansCare Allergy Antihistamine	DIPHENHYDRAMINE HYDROCHLORIDE	Acme United Corporation	5e31b1ff-291f-7b8c-e053-2a91aa0aedbc	2024-11-09	Warnings	Exact identifier application number: M012
Duraflu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	55fffc1d-8449-4c28-a391-c6f60dd85622	2024-11-09	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