equate nighttime cold and flu

Product NDC: 49035-324
11-digit product format: 490350324
Labeler code: 49035
Product ID: 49035-324_539fdc83-1fce-4dff-bc96-963f069bc93d
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Wal-Mart Stores Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-01-17
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 650; 30; 12.5 mg/30mL; 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: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	49035-324	49035-324-34	D	Discontinued by firm		2026-10-20
excluded package	package	49035-324	49035-324-50	D	Discontinued by firm		2026-10-20

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, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	49035-324-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	49035-324-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	49035-324-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	49035-324-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	49035-324-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	49035-324-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	49035-324-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	49035-324-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	49035-324-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	49035-324-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	49035-324-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	49035-324-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	49035-324-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	49035-324-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	49035-324-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	49035-324-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	49035-324-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	49035-324-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	49035-324-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	49035-324-50	`ad56d346431e…`	`cc804d4bbf1e…`

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: equate nighttime cold and flu
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE	30 mg/30mL
DOXYLAMINE SUCCINATE	12.5 mg/30mL

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
1043400	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
6ccbd537-2264-4b3c-804e-3d3ea5368a5f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49035-324-34	equate nighttime cold and flu	237 mL in 1 BOTTLE	SOLUTION	237		5
49035-324-40	equate nighttime cold and flu	355 mL in 1 BOTTLE	SOLUTION	355		5
49035-324-50	equate nighttime cold and flu	355 mL in 1 BOTTLE	SOLUTION	355		5
49035-324-50	equate nighttime cold and flu	2 in 1 CARTON	SOLUTION	2		5
49035-324-40	equate daytime cold and flu nighttime cold and flu	355 mL in 1 BOTTLE	SOLUTION	355 mL	30 mg in 30mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-324	EQUATE NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [WAL-MART STORES INC]	4	Current NDC, Legacy NDC, 4 package rows	20241027_6ccbd537-2264-4b3c-804e-3d3ea5368a5f.zip
49035-324	EQUATE DAYTIME COLD AND FLU NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [WAL-MART STORES INC]	3	Current NDC, Legacy NDC	20241114_983a4783-d826-41b6-8087-ca66bcd5b6ca.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 114 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucinex Sinus Max Clear and Cool	ACETAMINOPHEN AND GUAIFENESIN	RB Health (US) LLC	37de813a-54b7-672a-e063-6294a90a374e	2025-06-18	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	4a1aeb41-a8fa-4116-8068-e11acd608e58	2025-06-18	Warnings	Exact identifier application number: M012
NyQuil Cold and Flu w/VapoCOOL, 4ct, Travel BASIX	ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATED	Lil' Drug Store Products, Inc.	37c768f5-dabd-22d0-e063-6394a90af9e5	2025-06-17	Warnings	Exact identifier application number: M012
DISCOUNT DRUG MART Childrens Allergy Chewable	DIPHENHYDRAMINE HCL	DISCOUNT DRUG MART	51de95da-e8e8-48f0-9fa4-6191aa4a247b	2025-06-16	Warnings	Exact identifier application number: M012
Halls Cherry	MENTHOL	Mondelez Global LLC	5f4af8e8-8550-45c7-a199-694efac9e7be	2025-06-16	Warnings	Exact identifier application number: M012
Halls Honey Lemon	MENTHOL	Mondelez Global LLC	25eaae85-d516-40da-a472-70736ea2b75d	2025-06-16	Warnings	Exact identifier application number: M012
Halls Cherry	MENTHOL	Mondelez Global LLC	bad89968-22a7-4287-a57c-9e6206e574fe	2025-06-16	Warnings	Exact identifier application number: M012
Herbal Throat Drops	LEMON MINT HERBAL	Meijer, Inc.	37dd58ad-95d1-568c-e063-6394a90a9433	2025-06-16	Warnings	Exact identifier application number: M012
topcare childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Topco Associates LLC	40a6a7e3-6ec9-4005-9406-9d5b044b3c21	2025-06-16	Warnings	Exact identifier application number: M012
Daytime Nighttime Sinus Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL	Target Corporation	23f50b88-52c3-2029-e063-6394a90ac73e	2025-06-14	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Berries Flavor 25ct	PECTIN	Dollar General Corporation	c53c19a9-5984-4b08-ae46-a53dc8bb7d74	2025-06-13	Warnings	Exact identifier application number: M012
Cough Drops Dollar General Strawberry Flavor 25ct	PECTIN	Dollar General Corporation	d82034ca-b7fd-48c8-ab4a-8e1e56418324	2025-06-13	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	Belleview Biosciences	1db57d86-39f0-f8ca-e063-6394a90a6397	2025-06-12	Warnings	Exact identifier application number: M012
TARGET Cold and Cough and Nighttime Value Pack	BROMPHENIRAMINE MALEATE,DEXTROMETHORPHAN HBR,DIPHENHYDRAMINE HCL,	TARGET CORPORATION	ce536313-7265-405c-88b7-f45e62781da5	2025-06-11	Warnings	Exact identifier application number: M012
Capron Max	DEXTROMETHORPHAN HBR AND PYRILAMINE MALEATE	Capital Pharmaceutical, LLC	3756812b-f128-8946-e063-6294a90a59ba	2025-06-11	Warnings	Exact identifier application number: M012
SAFETUSSIN Non Drowsy Cough plus chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN	KRAMER LABORATORIES	60311ca3-8544-417e-aa29-e9f65c6692ba	2025-06-11	Warnings	Exact identifier application number: M012
Cold Max Nighttime	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	RETAIL BUSINESS SERVICES , LLC.	e65d2815-6932-123c-e053-2a95a90a2cf9	2025-06-10	Warnings	Exact identifier application number: M012
Cold Head Congestion Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	American Sales Company	0cc66c6c-db26-4bb2-a97d-c4106210d70c	2025-06-10	Warnings	Exact identifier application number: M012
Nighttime Cough DM	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	75a9c736-bc7e-4b7f-84ea-9474a37508ec	2025-06-10	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN	DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN	KJD Pharma Private Limited	8877bb8d-479f-4968-8033-5c269d449a46	2025-06-10	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
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	5
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	5
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	5
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	5
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	6ccbd537-2264-4b3c-804e-3d3ea5368a5f	5
2637726	{1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) } Pack	GPCK	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution) Pack	PSN	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral Solution	PSN	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1113705	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
2637726	1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 mL Oral Solution) Pack	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1113705	acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1113705	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1113705	APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	983a4783-d826-41b6-8087-ca66bcd5b6ca	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-324-34	49035032434	237 mL in 1 BOTTLE (49035-324-34)	237 ml	2020-01-17	0000-00-00	No	No	Current
49035-324-40	49035032440	355 mL in 1 BOTTLE (49035-324-40)	355 ml	2020-01-17	0000-00-00	No	No	Current
49035-324-50	49035032450	2 BOTTLE in 1 CARTON (49035-324-50) > 355 mL in 1 BOTTLE	2 bottle	2020-01-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Wal-Mart Daytime/Nighttime Cold & Flu Drug Facts	Wal-Mart Stores Inc	2026-06-12	HUMAN OTC DRUG LABEL	5
Wal-Mart Nighttime Cold & Flu Drug Facts	Wal-Mart Stores Inc	2025-09-05	HUMAN OTC DRUG LABEL	5