Night-Time

Product NDC: 53943-508
11-digit product format: 539430508
Labeler code: 53943
Product ID: 53943-508_efbf6971-12d1-4471-9443-cca8d13be3ec
Type: HUMAN OTC DRUG
Nonproprietary name: DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form: LIQUID
Route: ORAL
Labeler: Discount Drug Mart
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-10-27
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 30; 12.5 mg/30mL; mg/30mL
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: 2027-12-31
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 · 4 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
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53943-508-28	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53943-508-28	`9bebd1f3094a…`	`5416666fcb17…`

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
Brand name suffix: COUGH RELIEF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-12-31	3baea6f7-9524-46e8-ba82-8892f0842278
2020-12-31	3baea6f7-9524-46e8-ba82-8892f0842278
2020-01-31	3baea6f7-9524-46e8-ba82-8892f0842278
2020-01-31	3baea6f7-9524-46e8-ba82-8892f0842278

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53943-508-28	Night-TimeCOUGH RELIEF	354 mL in 1 BOTTLE	LIQUID	354		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
FD&C RED NO. 4	INACTIVE INGREDIENT	X3W0AM1JLX	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53943-508	NIGHT-TIME COUGH RELIEF (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DISCOUNT DRUG MART]	5	Current NDC, Legacy NDC, 1 package rows	20241222_3baea6f7-9524-46e8-ba82-8892f0842278.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 11 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORIGINAL Nasal PUMP MIST No Drip	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	ac27fd75-4fe4-433c-a434-2dac16c895c7	2026-08-07	Warnings	Exact identifier application number: M012
Winco Foods Childrens Allergy Relief Dye Free	DIPHENHYDRAMINE HYDROCHLORIDE	WINCO FOODS, LLC	a1367804-37c9-4906-858f-8feeb748d8d3	2026-08-07	Warnings	Exact identifier application number: M012
Severe Congestion Nasal Anti-Drip Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	WinCo FOODS, LLC	a09c2d02-334a-4840-b2d0-327121cec994	2026-08-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Intense Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreen Company	03aa43fd-4962-4c2c-9edd-e422a629a0e3	2026-08-06	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	f311b56f-b959-4070-9b23-82c642dd98b8	2026-08-06	Warnings	Exact identifier application number: M012
Cold Relief Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	L.N.K. International, Inc.	2ed25f69-89ef-4c50-946a-7e7b9df1ca8a	2026-08-06	Warnings	Exact identifier application number: M012
Eucamint	MENTHOL, CAMPHOR	Indiana Botanic Gardens	d79bc8de-9efb-4996-a55c-accda0f8edb2	2026-08-06	Warnings	Exact identifier application number: M012
NICOTINE GUM	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	4e88dab4-8e13-f074-e063-6394a90a3908	2026-08-06	Warnings	Exact identifier application number: M012
Oneoo Nicotine Gum (Mint)	NICOTINE POLACRILEX	Guangzhou Shuimu Jiahe Trading Co., Ltd.	54b1329b-b422-29a5-e063-6294a90a8780	2026-08-06	Warnings	Exact identifier application number: M012
Sine Aid PEAK MISERY	OXYMETAZOLINE HYDROCHLORIDE	Infirst Healthcare Inc.	586a2a14-7048-0c8b-e063-6394a90a65b7	2026-08-06	Warnings	Exact identifier application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Raritan Pharmaceuticals Inc	b745f45d-2042-4daa-9932-241836d7734b	2026-08-06	Warnings	Exact identifier application number: M012
Acetaminophen, Dextromethorphan HBr	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	NUVICARE LLC	6713fdff-0e4e-4a9d-b218-34f786339c57	2026-08-06	Warnings	Exact identifier application number: M012
Daytime Cold, Nighttime Cold multi-symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	3b462a5d-d48b-4b73-b5d4-d7944730bbdd	2026-08-06	Warnings	Exact identifier application number: M012
TOPCARE DAY TIME COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	d1b89d17-b3b9-4133-88a3-8cd7c4efafa9	2026-08-05	Warnings	Exact identifier application number: M012
Sinufrin Quick Relief Decongestant	SINUFRIN	Neilmed pharmaceuticals Inc.	0c36a34e-462d-713c-e063-6294a90a1776	2026-08-05	Warnings	Exact identifier application number: M012
No Drip	OXYMETAZOLINE HYDROCHLORIDE	NeilMed Pharmaceuticals Inc	e9b799ad-9164-7f30-e053-2a95a90a00c5	2026-08-05	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	507284c3-cad9-d65c-e063-6394a90a58a8	2026-08-05	Warnings	Exact identifier application number: M012
cough and cold relief HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	United Natural Foods, Inc. dba UNFI	90482e7a-d7c7-4127-972d-5ee55e55ed1c	2026-08-04	Warnings	Exact identifier application number: M012
DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Walgreen Company	78edeb7a-4712-4f04-9d76-d5b2d20ce76d	2026-08-04	Warnings	Exact identifier application number: M012
Cough and Cold HBP	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Better Living Brands, LLC	33f34aa2-3b37-4e51-8428-4a12708aa064	2026-08-04	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
1234386	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	3baea6f7-9524-46e8-ba82-8892f0842278	6
1234386	dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	3baea6f7-9524-46e8-ba82-8892f0842278	6
1234386	dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	3baea6f7-9524-46e8-ba82-8892f0842278	6
1234386	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	3baea6f7-9524-46e8-ba82-8892f0842278	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53943-508-28	53943050828	354 mL in 1 BOTTLE (53943-508-28)	354 ml	2014-10-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Night-Time COUGH RELIEF - Discount Drug Mart	Discount Drug Mart	2026-09-16	HUMAN OTC DRUG LABEL	7