good sense cold head congestion

Product NDC: 0113-0234
11-digit product format: 001130234
Labeler code: 0113
Product ID: 0113-0234_71b9c04a-a803-4c78-a3da-2b054d581702
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: L Perrigo Company
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2008-02-23
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 product	product	0113-0234		D	Discontinued by firm		2026-09-14
excluded package	package	0113-0234	0113-0234-62	D	Discontinued by firm		2026-09-14

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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`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	0113-0234-62	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0113-0234-62	EA - Each	0113-0234	7fa2abd1-dc18-4a12-a978-f6abbb96d3a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	GOOD SENSE COLD HEAD CONGESTION SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [L PERRIGO COMPANY]	2

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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

good sense cold head congestion

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#