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		2026-10-05
excluded package	package	49035-324	49035-324-50	D	Discontinued by firm		2026-10-05

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 9 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Childrens Cold and Allergy	BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	CVS PHARMACY, INC.	f4020c08-29f6-4609-834e-191ce6885130	2026-08-14	Warnings	Exact identifier application number: M012
CVS Severe Cough, Flu Plus Sore Throat Honey	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	CVS PHARMACY	95203001-7ca6-4513-83a3-9ef17855bc0f	2026-08-14	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	CVS PHARMACY	81d26e9c-b713-4fb3-b0a5-68526bad230e	2026-08-14	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Amazon.com Services LLC	212acd54-6ff0-446a-a3bb-3b40e1279711	2026-08-13	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Walgreen Company	e9d0b6f9-e9f3-431c-9f34-4d63108282a1	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Caramel Apple Cough Drops	MENTHOL	Bestco	58eee9b4-d696-995f-e063-6294a90a5db0	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Pumpkin Spice Cough Drops	MENTHOL	Bestco	58ef6619-9087-5f41-e063-6294a90a7da6	2026-08-13	Warnings	Exact identifier application number: M012
Best Health Bourbon Honey Cough Drops	MENTHOL	Bestco	58efdf29-83ea-03b9-e063-6294a90ad306	2026-08-13	Warnings	Exact identifier application number: M012
daytime nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL	Amazon.com Services LLC	9bb6bbd5-508e-4781-ad1c-69ccf0a5f13e	2026-08-13	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	1e3c81b0-05de-4c4a-8579-f301f14626b3	2026-08-13	Warnings	Exact identifier application number: M012
Tussin DM Daytime Nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	d59f6c64-8311-48ba-90d1-8000b04bfcda	2026-08-13	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU MULTI-SYMPTOM GELS DAY PLUS NIGHT	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Kenvue Brands LLC	1c5578e6-7e67-c467-e063-6294a90a6e0b	2026-08-12	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Amazon.com Services LLC	f95220c5-e55c-4271-a267-d004ad2447bf	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	569b8efa-8458-49f7-a665-6b7016a10505	2026-08-12	Warnings	Exact identifier application number: M012
CVS PHARMACY DYE FREE Childrens Allergy Chews	DIPHENHYDRAMINE HCL	CVS PHARMACY, INC.	e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7	2026-08-12	Warnings	Exact identifier application number: M012
Cold and Flu Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	af35c833-316a-4d21-bd3a-9b71558cadbf	2026-08-12	Warnings	Exact identifier application number: M012
Tussin DM Max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	cc77f3a6-48ce-41b5-bf4e-5ed7d8c69e2c	2026-08-11	Warnings	Exact identifier application number: M012
Best Health Maple Spice Cough Drops	MENTHOL	Bestco	58cfdacb-c713-220f-e063-6394a90acbfc	2026-08-11	Warnings	Exact identifier application number: M012
7 Select Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN	7-ELEVEN	f9475972-0cbb-45c5-9e49-09569f1665a7	2026-08-11	Warnings	Exact identifier application number: M012
Allergy Relief Childrens	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	6ec5445b-a1f2-47ba-99f7-5a4a6d0c29e3	2026-08-10	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