Cold and Flu

Product NDC: 42507-401
11-digit product format: 425070401
Labeler code: 42507
Product ID: 42507-401_aa6636ca-c096-46c0-aa90-eeb73b180129
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: HyVee Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-15
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: 2027-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42507-401	42507-401-34	D	Discontinued by firm		2026-10-12

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 · 36 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-401-34	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42507-401-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-401-34	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42507-401-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	42507-401-34	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42507-401-40	`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	42507-401-34	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42507-401-40	`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	42507-401-34	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42507-401-40	`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	42507-401-34	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42507-401-40	`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	42507-401-34	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42507-401-40	`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	42507-401-34	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42507-401-40	`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	42507-401-34	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42507-401-40	`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	42507-401-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42507-401-40	`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	42507-401-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42507-401-40	`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	42507-401-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42507-401-40	`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: Cold and Flu
Listing expiration: 2027-12-31

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
a16a85c2-e1fd-4d1a-a650-271ae430eb4f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42507-401-34	Cold and Flu	237 mL in 1 BOTTLE	SOLUTION	237		5
42507-401-40	Cold and Flu	355 mL in 1 BOTTLE	SOLUTION	355		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
FD&C GREEN NO. 3	INACTIVE INGREDIENT	3P3ONR6O1S	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
HIGH FRUCTOSE CORN SYRUP	INACTIVE INGREDIENT	XY6UN3QB6S	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HYVEE INC]	2

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 3 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dollar General	NASAL PHENYLEPHRINE HYDROCHLORIDE	DOLGENCORP, INC. (DOLLAR GENERAL & REXALL)	e8fd3f0e-a023-4423-8906-17ae02bc083b	2026-09-03	Warnings	Exact identifier application number: M012
Mucus Relief Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI	TARGET Corporation	1bf9a59e-cc37-4780-ba75-7138c546eb19	2026-09-02	Warnings	Exact identifier application number: M012
Childrens Multi Symptom Fever and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	THE KROGER CO.	3daf7620-eb57-43d5-ba88-938b7221e346	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	69fd13a1-2b76-8574-e053-2a91aa0a27e7	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp.	a6880389-0dc1-43a7-a73b-77f77bafe51e	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Gil Pharmaceutical Corp	fa8510d8-d50a-4743-ba87-a12e9ab43125	2026-09-02	Warnings	Exact identifier application number: M012
PHENAGIL	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL	Gil Pharmaceutical Corp	dfcf1231-8271-458d-b375-e328d6fd4e9b	2026-09-02	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Multi Symptom Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Shield Pharmaceuticals Corp	decafa3a-3734-4161-bab0-121945881846	2026-09-02	Warnings	Exact identifier application number: M012
Kroger Maximum Strength Severe Congestion and Cough	DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL	KROGER COMPANY	1ff037ea-1a3b-430a-be31-2e240cc3b6f3	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Mucus Relief DM Maximum Strength	DEXTROMETHORPHAN HBR AND GUAIFENESIN	KROGER COMPANY	79d24014-1af7-4d62-bcb8-5bea76a7d6ee	2026-09-02	Warnings	Exact identifier application number: M012
Kroger No Drip	ALLERGY SINUS	KROGER COMPANY	4788bafb-8866-4a0a-b217-226513799c24	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Cold Flu and Sore Throat	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	KROGER COMPANY	e1d27123-358f-4b0c-8e3b-33474750a0e6	2026-09-02	Warnings	Exact identifier application number: M012
Maximum Strength Nighttime Cold and Flu	ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL	THE KROGER CO	058b2021-8a61-40b0-8a2e-a784d2b847fb	2026-09-02	Warnings	Exact identifier application number: M012
KROGER Dye Free Childrens Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2bea22e9-34b6-4961-94bb-5600dd90e891	2026-09-02	Warnings	Exact identifier application number: M012
KROGER No Drip Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	KROGER COMPANY	7256e048-ad69-4322-844d-872f05e6fc8a	2026-09-02	Warnings	Exact identifier application number: M012
Daytime Cold and Flu Relief	ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL	The Kroger Co.	494e69ef-dc9f-4e14-b856-5eaf0f541a03	2026-09-02	Warnings	Exact identifier application number: M012
MAX Tussin Cough and Chest Congestion DM Sugar Free	DEXTROMETHORPHAN HBR, GUAIFENESIN	Akron Pharma Inc.	5c4c8115-cec9-4f2c-9ea9-328535e97b07	2026-09-01	Warnings	Exact identifier application number: M012
MAX ALLERGY KIDS	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	96c4ade8-67b1-41e5-8624-fb49090208af	2026-09-01	Warnings	Exact identifier application number: M012
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE	HEXYLRESORCINOL AND MENTHOL	Reckitt Benckiser LLC	4a938e15-a996-8538-e063-6294a90ad4ee	2026-09-01	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	WALMART INC.	5e6623c3-6210-4c50-94d6-5554f36876d1	2026-08-31	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	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	5
1043400	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SCD	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	5
1043400	acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution	SY	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	5
1043400	acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution	SY	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	5
1043400	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution	SY	a16a85c2-e1fd-4d1a-a650-271ae430eb4f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-401-34	42507040134	237 mL in 1 BOTTLE	237 ml				Historical
42507-401-40	42507040140	355 mL in 1 BOTTLE (42507-401-40)	355 ml	2014-01-15	No	No	Current