Severe Cold and Flu

Product NDC: 42507-597
11-digit product format: 425070597
Labeler code: 42507
Product ID: 42507-597_7172be88-9cab-4bf7-9882-e41ac912ea4c
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl
Dosage form: KIT
Labeler: HyVee Inc
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-05-19
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 24 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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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	42507-597-02	`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: Severe Cold and Flu
Brand name suffix: Nighttime Daytime
Listing expiration: 2027-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1369842	Internal RxNorm lookup
1431245	Internal RxNorm lookup
2637731	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
d4bcfabb-a054-4f53-8dc9-d361a03558b8	Available on FDA.report

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
DOXYLAMINE SUCCINATE	ACTIVE INGREDIENT	V9BI9B5YI2	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
DOXYLAMINE	ACTIVE MOIETY	95QB77JKPL	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
BUTYLATED HYDROXYANISOLE	INACTIVE INGREDIENT	REK4960K2U	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [HYVEE INC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SEVERE COLD AND FLU NIGHTTIME DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [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 110 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	BETTER LIVING BRANDS LLC.	f29da4ca-443d-7035-e053-2a95a90acab8	2025-07-14	Warnings	Exact identifier application number: M012
CVS PHARMACY MS Adult Severe Multi Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS PHARMACY	cdc9af7c-3766-4573-9d95-bf217907b932	2025-07-11	Warnings	Exact identifier application number: M012
Health Smart Vaporizing Chest Rub	MENTHOL AND CAMPHOR AND EUCALYPTUS OIL	International Wholesale Inc	398fee3d-7d93-9dbc-e063-6294a90abdcc	2025-07-10	Warnings	Exact identifier application number: M012
HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Kroger Company	bbed29a1-3c52-3531-e053-2995a90a686c	2025-07-10	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	b765c82e-5021-4772-8647-c5ebc596bc0a	2025-07-10	Warnings	Exact identifier application number: M012
Sinus Pressure and Pain	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreen Company	c378acaf-389a-4afb-a4f0-e367a907a468	2025-07-10	Warnings	Exact identifier application number: M012
Nasal Decongestant Non-Drowsy	PSEUDOEPHEDRINE HCL	CVS Pharmacy	3330b077-dab7-45c6-acbb-0f91f2271232	2025-07-09	Warnings	Exact identifier application number: M012
ACTIDOGESIC DF	ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE	ACTIPHARMA, LLC	ff8e2565-bce3-4c06-a416-6e8f369f057f	2025-07-09	Warnings	Exact identifier application number: M012
ACTINEL	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	db0cb6ae-0a4d-4232-805a-f3f3a058261f	2025-07-08	Warnings	Exact identifier application number: M012
HALLS Extra Strong	MENTHOL	Mondelez Global LLC	396f93a9-8d2c-2f27-e063-6294a90ab344	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	aea0335d-75e6-4a90-86a5-f197cf024a11	2025-07-08	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	P & L Development, LLC	0bb006f6-c360-4cd5-81e9-0776d99d79e8	2025-07-08	Warnings	Exact identifier application number: M012
childrens cold cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE	Meijer, Inc.	026e530f-e133-4f20-bac5-354fbb647c9e	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	CVS PHARMACY, INC	f59016f3-a8f8-4c95-9414-01440f0574d9	2025-07-08	Warnings	Exact identifier application number: M012
ACTINEL PEDIATRIC	DEXTROMETHORPHAN HBR,GUAIFENESIN,PSEUDOEPHEDRINE HCL	ACTIPHARMA, LLC	6bb92d74-4893-40b8-af58-eb307155e876	2025-07-08	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Maximum Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	776b7c67-56c7-420c-82b2-9a176d998396	2025-07-08	Warnings	Exact identifier application number: M012
ACTICON	DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIPHARMA, LLC	847014ab-86ae-40c5-8e7f-f1ddea14f1b3	2025-07-08	Warnings	Exact identifier application number: M012
Mucus Relief	GUAIFENESIN 400 MG	Cabinet Health, Inc.	26a51b0e-039c-663c-e063-6394a90ad384	2025-07-07	Warnings	Exact identifier application number: M012
EZ Nite Sleep	DIPHENHYDRAMINE HCL	Safeway, Inc.	21a68c60-3005-43bb-8ec5-7982239c93f8	2025-07-07	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	Pioneer Life Sciences, LLC	8188b66a-5405-4e62-bde6-63ebc1f22b16	2025-07-04	Warnings	Exact identifier application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42507-597-02	42507059702	1 KIT in 1 CARTON (42507-597-02) * 355 mL in 1 BOTTLE * 355 mL in 1 BOTTLE	1 kit	2014-05-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hy-Vee, Inc. Daytime/Nighttime Severe Cold & Flu Drug Facts	HyVee Inc	2026-05-14	HUMAN OTC DRUG LABEL	5