Childrens Robitussin Cough and Chest Congestion DM

Product NDC: 0031-8702
11-digit product format: 000318702
Labeler code: 0031
Product ID: 0031-8702_6755f338-34be-43e4-9cdf-bf2c2348cbbd
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hydrobromide and guaifenesin
Dosage form: LIQUID
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-05-12
Substance: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength: 20; 200 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

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: Childrens Robitussin Cough and Chest Congestion DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL
GUAIFENESIN	200 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
1790650	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
15950273-14c9-4a0b-bbb4-683048add722	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
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
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8702-13	Childrens Robitussin Cough and Chest Congestion DM	118 mL in 1 BOTTLE	LIQUID	118		4
0031-8702-13	Childrens Robitussin Cough and Chest Congestion DM	1 in 1 CARTON	LIQUID	1		4
0031-8702-13	RobitussinDay and Night Cough Relief Value Pack	118 mL in 1 BOTTLE	LIQUID	118 mL	200 mg in 20mL	1
0031-8702-13	RobitussinDay and Night Cough Relief Value Pack	1 in 1 CARTON	LIQUID		20 mg in 20mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8702	CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) LIQUID [HALEON US HOLDINGS LLC]	4	Current NDC, Legacy NDC, 2 package rows	20240209_15950273-14c9-4a0b-bbb4-683048add722.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 142 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cough Drops Honey Lemon with Sugar	MENTHOL	Lidl US LLC	4ad9398f-7488-6eaf-e054-00144ff8d46c	2024-11-05	Warnings	Exact identifier application number: M012
rexall dm cough and congestion relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	Dolgencorp, LLC	906838b1-a742-4728-944d-42b687b8cd59	2024-11-05	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HBR, GUAIFENESIN	H E B	7c24c59c-7549-4c64-95f8-4bf755cd6f61	2024-11-05	Warnings	Exact identifier application number: M012
equate adult tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Wal-Mart Stores Inc	3592e000-a6c6-47fe-8bb0-9341c65c2959	2024-11-05	Warnings	Exact identifier application number: M012
tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Walgreen Company	756794b0-8d3b-4732-947c-a407caf400e2	2024-11-05	Warnings	Exact identifier application number: M012
basic care tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Amazon.com Services LLC	c6863e31-e1b9-40ff-ae2e-4aec86b4acc0	2024-11-05	Warnings	Exact identifier application number: M012
topcare tussin dm max	DEXTROMETHORPHAN HBR, GUAIFENESIN	Topco Associates LLC	94c35025-7bb4-4cb0-8bf3-4b44bb7fa59a	2024-11-05	Warnings	Exact identifier application number: M012
Childrens Sudafed PE NASAL DECONGESTANT	PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	2024-11-04	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Safeway, Inc.	164b2559-2d3f-431e-a03c-07e86731af5c	2024-11-04	Warnings	Exact identifier application number: M012
tussin severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	H E B	7cc2c136-d1b7-4658-99bb-73bb1d140261	2024-11-04	Warnings	Exact identifier application number: M012
dg health tussin	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	a5d0ee70-d528-4a53-bf01-7bb13b364ed0	2024-11-04	Warnings	Exact identifier application number: M012
basic care tussin cf severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	bba9a17d-eb87-46f3-acee-c9dd34e5bfd4	2024-11-04	Warnings	Exact identifier application number: M012
topcare tussin cf max	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	b553b7e6-933b-49e3-97d3-22a4643a04b9	2024-11-04	Warnings	Exact identifier application number: M012
dg health nasal original	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	fb209752-705a-4bb0-9298-8b70357f3911	2024-11-02	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	H E B	3c301993-642a-487c-96a2-ebc4ef90dc88	2024-11-02	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	1341744c-43c3-462b-b93c-1e46476fd935	2024-11-01	Warnings	Exact identifier application number: M012
Nighttime Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	43784616-1afd-4ff7-8fee-6ac389f616a2	2024-11-01	Warnings	Exact identifier application number: M012
topcare nite time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Topco Associates LLC	28ef87e8-29e5-444d-b1f7-5c38a7f758d3	2024-11-01	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	0e3c36c9-d45b-41b9-891d-a42d854295f9	2024-11-01	Warnings	Exact identifier application number: M012
severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	7dc3941a-e5f8-4caa-bae5-6a0d075295cb	2024-11-01	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
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	15950273-14c9-4a0b-bbb4-683048add722	4
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	15950273-14c9-4a0b-bbb4-683048add722	4
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	15950273-14c9-4a0b-bbb4-683048add722	4
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	15950273-14c9-4a0b-bbb4-683048add722	4
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	15950273-14c9-4a0b-bbb4-683048add722	4
2362250	{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) } Pack	GPCK	4029eccd-5443-4ae2-9232-2a1d922798f8	1
2362250	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 20 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) Pack	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	4029eccd-5443-4ae2-9232-2a1d922798f8	1
2362250	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) Pack	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8702-13	00031870213	1 BOTTLE in 1 CARTON (0031-8702-13) / 118 mL in 1 BOTTLE	1 bottle	2020-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2025-10-15	HUMAN OTC DRUG LABEL	1
Drug Facts	Haleon US Holdings LLC \| Pf Soins De Santé Sri	2024-02-08	HUMAN OTC DRUG LABEL	4