NIGHTTIME COLD AND FLU RELIEF

Product NDC: 58602-769
11-digit product format: 586020769
Labeler code: 58602
Product ID: 58602-769_ce31ced0-439e-4668-94aa-fd09cc636669
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate
Dosage form: CAPSULE
Route: ORAL
Labeler: Aurohealth LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-29
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes: 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]
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
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58602-769-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58602-769-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58602-769-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58602-769-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58602-769-15	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58602-769-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58602-769-15	`0efc9e666f02…`	`f202fb6c5f17…`
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	58602-769-15	`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	58602-769-15	`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	58602-769-15	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: NIGHTTIME COLD AND FLU RELIEF
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/1
DOXYLAMINE SUCCINATE	6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1094549	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
70e1bd25-c32e-491f-b383-91d6f74957a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58602-769-78	NIGHTTIME COLD AND FLU RELIEF	8 in 1 BLISTER PACK	CAPSULE	8	4
58602-769-78	NIGHTTIME COLD AND FLU RELIEF	3 in 1 CARTON	CAPSULE	3	4
58602-769-79	NIGHTTIME COLD AND FLU RELIEF	1 in 1 CARTON	CAPSULE	1	4
58602-769-79	NIGHTTIME COLD AND FLU RELIEF	8 in 1 BLISTER PACK	CAPSULE	8	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58602-769	NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE) CAPSULE [AUROHEALTH LLC]	4	Current NDC, Legacy NDC, 4 package rows	20250510_70e1bd25-c32e-491f-b383-91d6f74957a0.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 25 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Childrens Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	00689aa5-ed39-4c9a-92b8-105d2c0e2e15	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Reckitt Benckiser LLC	9aca1a68-893c-4770-8a48-d5d678058253	2026-05-27	Warnings	Exact identifier application number: M012
Childrens Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	d26b5143-aa07-4114-a6ba-4f503aadd46f	2026-05-27	Warnings	Exact identifier application number: M012
Goodmeds Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	37533188-8c91-428b-a796-c5afd9e4959f	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Chest Congestion DM	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	Reckitt Benckiser LLC	8252cdec-b668-4450-b045-e093479ab542	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Nighttime Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE	Reckitt Benckiser LLC	27f9d2db-38ce-41d2-8f1a-0eb171600274	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough Plus Sore Throat	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	b37b786e-0cce-419d-94ed-3b64a1eb1201	2026-05-27	Warnings	Exact identifier application number: M012
Delsym Cough	DEXTROMETHORPHAN HYDROBROMIDE	Reckitt Benckiser LLC	a43d59f9-3a6c-4a7c-b98d-b86d6035f716	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Relief Severe Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Rite Aid Corporation	5700ef26-ffa6-480a-bf36-bd5111799e9b	2026-05-27	Warnings	Exact identifier application number: M012
Air Power	GUAIFENESIN	Schwabe North America, Inc	5cdefc7a-6242-4681-88a3-04422a1d48d3	2026-05-27	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALMART INC.	adb658c8-db8d-4db6-80c8-e0f2de88a2de	2026-05-27	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Non Drowsy	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS Pharmacy	c71427d4-707f-411f-8bd4-133517a9992b	2026-05-26	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL	CVS PHARMACY, INC	643e929d-9e62-4260-91ee-e88a184dd7cd	2026-05-26	Warnings	Exact identifier application number: M012
TopCare Day Time Nite Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	c00ff684-acaf-4fbe-bc74-7e48751b927d	2026-05-26	Warnings	Exact identifier application number: M012
Goodmeds Non-Drowsy Nasal Decongestant PE	PHENYLEPHRINE	Cabinet Health P.B.C.	4e75da23-35f2-431c-92cb-c2c4cb3f09f1	2026-05-26	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief Multi Symptom	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	CVS Pharmacy	13492631-d5de-4562-a201-664f7d3591de	2026-05-26	Warnings	Exact identifier application number: M012
Sinufrin Decongestant	NASAL CONGESTION RELIEF	NeilMed Pharmaceuticals Inc	52a2e5f9-e0a2-02f7-e063-6294a90a3ae9	2026-05-25	Warnings	Exact identifier application number: M012
Cough Suppressant Adult	DEXTROMETHORPHAN HYDROBROMIDE	Rugby Laboratories	47b713bd-4c1e-f44a-e063-6294a90a63d3	2026-05-25	Warnings	Exact identifier application number: M012
ClorRelief	CHLORPHENIRAMINE MALEATE	FERRER MEDICAL INNOVATIONS LLC	db729011-f72f-5911-e053-2a95a90a68bf	2026-05-22	Warnings	Exact identifier application number: M012
Childrens Dye Free Allergy Relief	DIPHENHYDRAMINE HCL	Rite Aid Corporation	74ff4f0d-7952-4b74-b1b2-5a2beab91f7c	2026-05-22	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1094549	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule	PSN	70e1bd25-c32e-491f-b383-91d6f74957a0	4
1094549	acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SCD	70e1bd25-c32e-491f-b383-91d6f74957a0	4
1094549	APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule	SY	70e1bd25-c32e-491f-b383-91d6f74957a0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58602-769-15	58602076915	16 CAPSULE in 1 BOTTLE (58602-769-15)	16 capsule	2019-12-31	0000-00-00	No	No	Current
58602-769-78	58602076978	3 BLISTER PACK in 1 CARTON (58602-769-78) / 8 CAPSULE in 1 BLISTER PACK	3 blister pack	2024-06-29		No	No	Current
58602-769-79	58602076979	1 BLISTER PACK in 1 CARTON (58602-769-79) / 8 CAPSULE in 1 BLISTER PACK	1 blister pack	2024-06-29		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NIGHTTIME COLD AND FLU RELIEF Drug Facts	Aurohealth LLC \| APL HEALTHCARE LIMITED	2025-04-28	Human OTC Drug Label	4