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		2026-10-23

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 139 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Poly-Vent IR	GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	ce0d8c45-446a-4df4-a36b-5000ba69d30d	2024-11-09	Warnings	Exact identifier application number: M012
basic care tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amazon.com Services LLC	306d5914-03ed-410a-9345-c54ba604e991	2024-11-09	Warnings	Exact identifier application number: M012
care one nasal original	OXYMETAZOLINE HYDROCHLORIDE	American Sales Company	a0c35e06-c9e9-438e-8224-d4760b6e2aff	2024-11-09	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	34174507-cf2e-4ed4-85ec-f915d4b910df	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Chewables	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	b08f71d8-a06c-41ba-8ed1-fbc41dbc1919	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE SINUS CONGESTION	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	a38fdfb8-db89-487f-9b68-aa9152b91f5f	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED Sinus Congestion	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	c05d7e27-6821-468f-b27d-9c0b02a07b0f	2024-11-08	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	2884d2dc-2d4a-4ca6-ab73-688a80b428eb	2024-11-08	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATE	Kenvue Brands LLC	712ba011-79aa-469b-9f0f-04a0b4b705bd	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	8538c291-9ce9-4866-b268-f4cbdb52f5bd	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Sudafed Nasal Decongestant	PSEUDOEPHEDRINE HYDROCHLORIDE	Kenvue Brands LLC	52e9307b-ad38-4f65-bb2f-4fa262e82010	2024-11-08	Warnings	Exact identifier application number: M012
Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	685b51d3-cc25-47b2-ac8a-368924f43137	2024-11-08	Warnings	Exact identifier application number: M012
Sudafed PE Sinus Pressure Plus Pain	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	60183922-bfd3-4377-884a-51b2f0a4c93a	2024-11-08	Warnings	Exact identifier application number: M012
Sudafed PE Sinus Congestion	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ca08917-1a75-4365-8520-c083e6a4225a	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Head Congestion Plus Mucus	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	f0739186-41b9-4761-adf7-08101b30a18e	2024-11-08	Warnings	Exact identifier application number: M012
SUDAFED PE Head Congestion Plus Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	1e528f78-0ced-4a06-935a-84056c921727	2024-11-08	Warnings	Exact identifier application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	657a1e59-104c-4152-b2c9-00a8b82dc78e	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold Max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	47c61858-72ce-409b-a3af-a63620cf7d13	2024-11-08	Warnings	Exact identifier application number: M012
Childrens Benadryl Allergy Plus Congestion	DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	b8b75904-3806-4258-89c1-d6ff486ed41c	2024-11-08	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	464de5de-0e7a-41d6-875f-dd0e5fe7893c	2024-11-08	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	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