ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM

Product NDC: 0031-8739
11-digit product format: 000318739
Labeler code: 0031
Product ID: 0031-8739_4265eb55-7d39-8ba5-e063-6394a90ad0e5
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hbr, guaifenesin
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-06-01
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 400 mg/20mL; mg/20mL
Pharmacologic classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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: 2026-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0031-8739		D	Discontinued by firm		2026-10-21
excluded package	package	0031-8739	0031-8739-16	D	Discontinued by firm		2026-10-21

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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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	0031-8739-16	`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: ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL
GUAIFENESIN	400 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
495W7451VQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020138	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
f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	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
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8739-12	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	118 mL in 1 BOTTLE	SOLUTION	118		11
0031-8739-12	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	1 in 1 CARTON	SOLUTION	1		11
0031-8739-18	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	237 mL in 1 BOTTLE	SOLUTION	237		11
0031-8739-18	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	1 in 1 CARTON	SOLUTION	1		11
0031-8739-42	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	1 in 1 CARTON	SOLUTION	1		11
0031-8739-42	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM	355 mL in 1 BOTTLE	SOLUTION	355		11
0031-8739-12	RobitussinDay and Night Cough Relief DM Max	118 mL in 1 BOTTLE	SOLUTION	391 mL	400 mg in 20mL	4
0031-8739-12	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	SOLUTION		400 mg in 20mL	4
0031-8739-18	RobitussinDay and Night Cough Relief DM Max	237 mL in 1 BOTTLE	SOLUTION	391 mL	20 mg in 20mL	4
0031-8739-18	RobitussinDay and Night Cough Relief DM Max	1 in 1 CARTON	SOLUTION		400 mg in 20mL	4
0031-8739-12	RobitussinDay and Night Maximum Strength Cough DM	118 mL in 1 BOTTLE	SOLUTION	118 mL	20 mg in 20mL	1
0031-8739-12	RobitussinDay and Night Maximum Strength Cough DM	1 in 1 CARTON	SOLUTION		400 mg in 20mL	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8739-12	ML - Milliliter	0031-8739	c74cd6a5-e068-49f9-9e21-9def37d91daf	1	2017-07-07
0031-8739-18	ML - Milliliter	0031-8739	bb0238dd-eb2f-4f38-b964-9e4d0d50dbdd	1	2017-05-03
0031-8739-42	ML - Milliliter	0031-8739	9a7d2b18-ffa6-4c40-ae58-5a11176deb2c	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8739	ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 6 package rows	20250316_f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7.zip
0031-8739	ROBITUSSIN DAY AND NIGHT COUGH RELIEF DM MAX (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE) KIT [HALEON US HOLDINGS LLC]	2	Current NDC, Legacy NDC	20250507_b3d02c91-8f79-4eb4-a378-1072474c572c.zip

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 71 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Honey Lemon cough drops	MENTHOL	Walmart Stores Inc.	317bbd33-6087-3af1-e054-00144ff8d46c	2025-12-21	Warnings	Exact identifier application number: M012
Good Sense Nasal Decongestant	PSEUDOEPHEDRINE HCL	L. Perrigo Company	455b35b4-3969-411b-8036-887615d71e11	2025-12-21	Warnings	Exact identifier application number: M012
Menthol Cough Drop	MENTHOL	Safeway Inc.	4a4f7f82-1b6c-7082-e054-00144ff88e88	2025-12-20	Warnings	Exact identifier application number: M012
Cherry Cough Drop	MENTHOL	Safeway Inc.	4a52c0c2-8659-2819-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
Signature Care Cherry Cough Drops	MENTHOL	Safeway	a733e905-af15-d3ea-e053-2a95a90aa7c3	2025-12-20	Warnings	Exact identifier application number: M012
Signature Care Honey Lemon Cough Drops	MENTHOL	Safeway	a742449f-c76b-2b91-e053-2a95a90ae4d2	2025-12-20	Warnings	Exact identifier application number: M012
Cherry Sore Throat Lozenge	BENZOCAINE	TopCo	60b876e7-c642-5ce8-e053-2a91aa0abd6e	2025-12-20	Warnings	Exact identifier application number: M012
menthol cough drops	MENTHOL	Topco Associates	366cc6b1-beff-29d2-e054-00144ff88e88	2025-12-20	Warnings	Exact identifier application number: M012
cherry cough drops	MENTHOL	TopCo Associates	3fef2117-7311-1e66-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
honey lemon cough drops	MENTHOL	Topco Associates	3ff1bf05-e407-3b67-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
sugar free menthol cough drops	MENTHOL	Topco Associates	36727f0c-d6d2-28a3-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
sugar free honey lemon cough drops	MENTHOL	Topco Associates	36824bee-607e-7095-e054-00144ff8d46c	2025-12-20	Warnings	Exact identifier application number: M012
Mixed Berry Sore Throat Lozenges	BENZOCAINE	Topco Associates	7a00c771-9231-e877-e053-2a91aa0ac96e	2025-12-20	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN 400 MG	NUVICARE LLC	e25b440e-f389-443f-b333-c66ad1747158	2025-12-19	Warnings	Exact identifier application number: M012
Cold and Flu severe	ACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCL	Wal-Mart Stores Inc	9fca25dc-f63e-487a-8b7c-84d65ea51cb5	2025-12-19	Warnings	Exact identifier application number: M012
Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Geiss, Destin & Dunn Inc.	a7d2eaee-484e-43aa-8ae3-0e050219383f	2025-12-19	Warnings	Exact identifier application number: M012
Cherry Cough Drops	MENTHOL	Publix	66d8e5f7-9766-57f3-e053-2991aa0a7e17	2025-12-19	Warnings	Exact identifier application number: M012
Honey Lemon Cough Drops	MENTHOL	Publix	66e89fa3-ee09-1d16-e053-2a91aa0ae17c	2025-12-19	Warnings	Exact identifier application number: M012
Poly-Vent DM	DEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCL	Poly Pharmaceuticals, Inc.	739329ae-0b62-4eab-a07d-867b5d3d61e0	2025-12-19	Warnings	Exact identifier application number: M012
Chest Congestion and Cough Relief DM	DEXTROMETHORPHAN HBR, GUAIFENESIN	ARMY AND AIR FORCE EXCHANGE SERVICE	89494a7c-cdbf-48f1-aaa9-2e57d4388a68	2025-12-19	Warnings	Exact identifier application number: M012

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	11
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	11
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	11
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	f1d022dd-c2ca-497f-87d5-9ef3e20e8ea7	11
2056073	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	b3d02c91-8f79-4eb4-a378-1072474c572c	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	b3d02c91-8f79-4eb4-a378-1072474c572c	4
2056073	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	b3d02c91-8f79-4eb4-a378-1072474c572c	4
2056073	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
2056073	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) Pack	PSN	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution	PSN	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution	SCD	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
2056073	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) Pack	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1020138	dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	b43d8fbd-1977-4465-aa64-79e7b7f54e09	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8739-12	00031873912	1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current
0031-8739-18	00031873918	1 BOTTLE in 1 CARTON (0031-8739-18) / 237 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current
0031-8739-42	00031873942	1 BOTTLE in 1 CARTON (0031-8739-42) / 355 mL in 1 BOTTLE	1 bottle	2016-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2025-11-07	HUMAN OTC DRUG LABEL	1
Drug Facts	Haleon US Holdings LLC	2025-10-30	HUMAN OTC DRUG LABEL	11
Drug Facts	Haleon US Holdings LLC	2025-10-30	HUMAN OTC DRUG LABEL	4