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 58 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mixed Berry Throat and Cough Lozenges	BENZOCAINE	CVS Pharmacy	737b1c88-1a44-68cf-e053-2991aa0a35b6	2026-01-16	Warnings	Exact identifier application number: M012
Walgreens Wild Cherry Throat Drops	PECTIN	Walgreens	4885eca3-c1e9-8350-e063-6394a90ac290	2026-01-16	Warnings	Exact identifier application number: M012
HBP Chest Congestion and Cough Relief	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Walgreens	ff7a1462-9994-4421-85aa-c03488bb04cf	2026-01-16	Warnings	Exact identifier application number: M012
Cough Relief	DEXTROMETHORPHAN HBR	WALGREEN COMPANY	a793acbc-107c-4638-a2d7-65f4e96cafda	2026-01-16	Warnings	Exact identifier application number: M012
MUCUS RELIEF DM	GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE	Walgreens	ca53ec26-d167-1780-e053-2a95a90a5b88	2026-01-16	Warnings	Exact identifier application number: M012
Maximum Strength Congestion and Headache	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	88da92d2-92c2-445a-9b70-58996e086014	2026-01-16	Warnings	Exact identifier application number: M012
Maximum Strength Cold and Flu	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	5f638bca-55c2-4ead-8c47-3f15713495da	2026-01-16	Warnings	Exact identifier application number: M012
COLD, Flu and Sore Throat	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Walgreens	190175bb-c08a-4050-aacf-29a130cbe05c	2026-01-16	Warnings	Exact identifier application number: M012
Night Time Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	FSA Store Inc. (Caring Mills)	a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff	2026-01-16	Warnings	Exact identifier application number: M012
Allergy Multi-Symptom	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	L.N.K. International, Inc.	99147338-f459-4423-ae54-f96fffc1728d	2026-01-15	Warnings	Exact identifier application number: M012
SanaTos Severe Cold Relief Nighttime	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	144aafcc-6ec2-a322-e063-6294a90afc27	2026-01-15	Warnings	Exact identifier application number: M012
SanaTos Severe Cold and Cough Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE	Pharmadel LLC	14484bf5-ff45-b859-e063-6394a90a9a0f	2026-01-15	Warnings	Exact identifier application number: M012
Foster and Thrive Chest Congestion Relief PE PE	GUAIFENESIN/PHENYLEPHRINE	Strategic Sourcing Services LLC	3429aedc-e83d-498a-bfca-03aaf5847b3b	2026-01-15	Warnings	Exact identifier application number: M012
Quality Choice Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	4b86101c-00f8-4ede-807f-db4273b37b8d	2026-01-15	Warnings	Exact identifier application number: M012
Quality Choice Mucus Relief DM DM	DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN	Chain Drug Marketing Association	d1ba7267-6844-4a14-b518-65277a32e855	2026-01-15	Warnings	Exact identifier application number: M012
ACTINEL DM Pediatric	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	f85d8586-423f-48a3-9bb2-bbc5984c7cd3	2026-01-15	Warnings	Exact identifier application number: M012
ACTINEL Diabetic	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	ACTIPHARMA, LLC	35c21623-84dd-4151-b35b-e7d30b69c9c0	2026-01-15	Warnings	Exact identifier application number: M012
Pocket Farmacy	MENTHOL	Saje Natural Business Inc.	bdc15c6f-73b4-488e-9134-e70565df71bb	2026-01-14	Warnings	Exact identifier application number: M012
Allergy Relief Diphenhydramine HCL 50 MG	DIPHENHYDRAMINE HCL	YYBA Corporation	4b012549-3958-43c1-9de7-897c5d8b20d3	2026-01-14	Warnings	Exact identifier application number: M012
Rite Aid Pharmacy congestion relief vaporizing steam	VAPORIZING STEAM	Rite Aid Pharmacy	0fb86b23-0313-8fd8-e063-6394a90a0f5f	2026-01-14	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