Childrens Robitussin Honey Nighttime Cough DM

Product NDC: 0031-8762
11-digit product format: 000318762
Labeler code: 0031
Product ID: 0031-8762_350764de-7804-b24e-e063-6394a90ab3c3
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hbr, doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-27
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 15; 6.25 mg/10mL; mg/10mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Honey Nighttime Cough DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/10mL
DOXYLAMINE SUCCINATE	6.25 mg/10mL

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
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115329	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
6afaf85b-bf0c-4c99-acf3-a34f06be20f1	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
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
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
0031-8762-12	Childrens Robitussin Honey Nighttime Cough DM	118 mL in 1 BOTTLE	SOLUTION	118		11
0031-8762-12	Childrens Robitussin Honey Nighttime Cough DM	1 in 1 CARTON	SOLUTION	1		11
0031-8762-12	RobitussinChildrens Honey Day Night DM Value Pack	118 mL in 1 BOTTLE	SOLUTION	1 mL	15 mg in 10mL	2
0031-8762-12	RobitussinChildrens Honey Day Night DM Value Pack	1 in 1 CARTON	SOLUTION		6.25 mg in 10mL	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8762-12	ML - Milliliter	0031-8762	6760d42d-7a3c-47dd-9c2a-f30d8cec6e43	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8762	CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20250515_6afaf85b-bf0c-4c99-acf3-a34f06be20f1.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 140 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
McKesson Phenylephrine HCl	PHENYLEPHRINE HCL	McKesson Medical-Surgical	e09060f7-ca0b-5f7c-e053-2995a90ab344	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	e0e216ef-300c-4f57-87e6-62a5327e09b4	2024-11-08	Warnings	Exact identifier application number: M012
basic care daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	969c0718-ba6e-4edb-9f55-43bc9500450f	2024-11-08	Warnings	Exact identifier application number: M012
daytime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreen Company	62a70d9a-4e78-497c-8f75-012ab94e92f6	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Publix Super Markets Inc	25b2ad8a-5835-4496-815f-73a7fb40dcfd	2024-11-08	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Rite Aid Corporation	296f20c0-8b5f-4a08-9329-f93c92e63867	2024-11-08	Warnings	Exact identifier application number: M012
topcare tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Topco Associates LLC	d3cae69e-41a5-4099-a3f4-ce25fd94df73	2024-11-08	Warnings	Exact identifier application number: M012
foster and thrive daytime severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	9d147d1e-8ea5-4e0f-8ae8-1da16f119496	2024-11-08	Warnings	Exact identifier application number: M012
equate adult cough and chest congestion dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	WALMART INC.	e770bdb2-3662-4538-8199-fe4a4059c720	2024-11-08	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	23dcb627-c867-435f-9d1a-a9f49e58b58f	2024-11-08	Warnings	Exact identifier application number: M012
good neighbor pharmacy adult tussin DM	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	ced71993-f535-4e28-bc1d-3fcb7d86e9b7	2024-11-08	Warnings	Exact identifier application number: M012
adult tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	CVS Pharmacy	2f1dc8f8-79c5-4724-99aa-a55330ed9d5f	2024-11-08	Warnings	Exact identifier application number: M012
good sense day time cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	L. Perrigo Company	4ac6b64a-8214-4b03-8aa5-0d3199cf0b72	2024-11-08	Warnings	Exact identifier application number: M012
tussin	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	H E B	1dd9afb6-9b58-4274-a557-900a0cb23524	2024-11-08	Warnings	Exact identifier application number: M012
DG health sinus severe	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	7abaa912-be8b-463c-8818-104e79b33539	2024-11-07	Warnings	Exact identifier application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day	ACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	7d3266dc-879a-4d28-b8ea-74d238c3020a	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHT	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	2ddb86a8-e34c-4a03-a60a-d3fedaf90608	2024-11-07	Warnings	Exact identifier application number: M012
Tylenol Cold Plus Head Congestion Severe	ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	ce43e5c2-fe96-4462-882c-d7479318b33d	2024-11-07	Warnings	Exact identifier application number: M012
TYLENOL SINUS PLUS HEADACHE DAY	ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	e608d214-cc46-4a24-ac85-1040e36e7403	2024-11-07	Warnings	Exact identifier application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT	ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE	Kenvue Brands LLC	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	2024-11-07	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
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
2722413	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	f9999875-3433-4052-a628-39539d373216	2
2722413	1 daytime (dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG in 10 mL Oral Solution) Pack	PSN	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	f9999875-3433-4052-a628-39539d373216	2
2722413	1 daytime (dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG per 10 ML Oral Solution) Pack	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8762-12	00031876212	1 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLE	1 bottle	2019-05-27	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	2
Drug Facts	Haleon US Holdings LLC	2025-05-13	HUMAN OTC DRUG LABEL	11