Cough Control DM

Product NDC: 15127-806
11-digit product format: 151270806
Labeler code: 15127
Product ID: 15127-806_a5dce154-e0e4-4c7f-a0c6-1e09c391b5e4
Type: HUMAN OTC DRUG
Nonproprietary name: Dextromethorphan HBr, Guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Select Brand Dist.
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-09-08
Marketing end: 2019-12-31
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 10 mg/5mL; mg/5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	15127-806		D	Discontinued by firm		2026-10-12
excluded package	package	15127-806	15127-806-04	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 · 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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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	15127-806-04	`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
15127-806-04	ML - Milliliter	15127-806	c6560ff1-2ee4-451a-a893-3ebdc2545da3	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
GUAIFENESIN	ACTIVE INGREDIENT	495W7451VQ	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
GUAIFENESIN	ACTIVE MOIETY	495W7451VQ	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	COUGH CONTROL DM SUGAR FREE (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [SELECT BRAND DIST.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN

Cough Control DM

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#