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		2026-10-15
excluded package	package	49035-324	49035-324-50	D	Discontinued by firm		2026-10-15

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 60 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	bab078bb-f6b0-4394-84de-92b2c582b5da	2026-01-12	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Non-Drowsy Maximum Strength	PHENYLEPHRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d	2026-01-12	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	022c3083-c611-47d0-aa93-d6c7612e7a47	2026-01-11	Warnings	Exact identifier application number: M012
CVS Health Medicated Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	CVS Pharmacy	bf73d15a-9d68-42fa-bfee-d25748215f97	2026-01-11	Warnings	Exact identifier application number: M012
GUAIFENESIN 400MG CAPLETS	GUAIFENESIN	Gendose Pharmaceuticals, LLC	e7b82ec7-ef23-50c1-e053-2a95a90a662f	2026-01-10	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	DAYTIME COLD AND FLU	Allegiant Health	69ed2da0-16b2-49eb-91b4-cc5cf328c817	2026-01-09	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	HY-VEE, INC	47f81e54-0ce4-439d-e063-6294a90a2abe	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	a5809774-ed52-4f54-b48e-888631e0223d	2026-01-09	Warnings	Exact identifier application number: M012
Diphenhydramine HCL	DIPHENHYDRAMINE HCL	A-S Medication Solutions	5767f546-a751-4583-a8b7-971175c27ef0	2026-01-09	Warnings	Exact identifier application number: M012
Thompson Cough and Cold Multi-Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE, GUAIFENESIN, ,	Thompson	e77725b1-15da-35bd-e053-2a95a90ad6ba	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Childrens Multi-Symptom Grape	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	266c8cce-cdf9-557d-e063-6394a90a9bc3	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Honey	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	2669c620-ab70-abaa-e063-6394a90a58e7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Multi-Symptom Cherry	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26b8c06d-4a72-3979-e063-6394a90a96d7	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Max with Acetaminophen	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE	Menper Distributors, Inc.	26a4861b-5d8e-9ec6-e063-6394a90af577	2026-01-08	Warnings	Exact identifier application number: M012
Mucosan Severe Multi-Symptom	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Menper Distributors, Inc.	26a69342-f65f-cb46-e063-6394a90ade10	2026-01-08	Warnings	Exact identifier application number: M012
HyVee Cough Drops Original Herb	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	e4e15c13-f583-4484-a5f0-f04c39c7b7c9	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Non Drowsy	ASPRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	a355d987-77ce-9e32-e053-2995a90a6431	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e07931fc-f753-1aeb-e053-2a95a90ada3f	2026-01-08	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night	ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE	Bayer HealthCare LLC.	fc60af2f-83cb-99ea-e053-6394a90a0b3b	2026-01-08	Warnings	Exact identifier application number: M012
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Bayer HealthCare LLC.	e17eb929-209d-a2d1-e053-2a95a90a4cf3	2026-01-08	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