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 172 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	bcc1a001-4176-485d-aaf0-2037ca65c6b8	2023-12-14	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	Major Pharmaceuticals	edb49b17-06a7-4c25-bc7c-d62c1deac7f1	2023-12-13	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline No Drip	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	0c006b1c-8ab2-4b9c-8738-e7001c1bb47d	2023-12-11	Warnings	Exact identifier application number: M012
Daytime Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN,/ ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORP	0b1e230d-4354-bf61-e063-6394a90a2b2f	2023-12-09	Warnings	Exact identifier application number: M012
Phenylephrine HCl Maximum Strength	PHENYLEPHRINE HCL	A-S Medication Solutions	fcb769d0-aa45-48eb-acd0-2247b392f9fe	2023-12-09	Warnings	Exact identifier application number: M012
Daytime and Nighttime Severe Honey Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf915af-a016-0a46-e063-6394a90aacf5	2023-12-08	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and Flu	DAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCI	TARGET Corporation	0bf9c0df-7676-3060-e063-6394a90a16c7	2023-12-08	Warnings	Exact identifier application number: M012
Nazal	NAPHAZOLINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	4d4043f8-5ed3-4027-beb6-687db1308202	2023-12-06	Warnings	Exact identifier application number: M012
Family Wellness Oxymetazoline	OXYMETAZOLINE	FAMILY DOLLAR (Family Wellness)	8b4557d4-74a0-400f-ad7a-6d31473b3c67	2023-12-06	Warnings	Exact identifier application number: M012
Childrens Plus Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCI	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	1598e6f8-08ee-4216-a5ab-76cad37b09a7	2023-12-06	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Fragile Skin Protectant	PETROLATUM	Welmedix LLC	6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf	2023-12-05	Warnings	Exact identifier application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash Relief	PETROLATUM, ZINC OXIDE	Welmedix LLC	551e6cce-7adc-4e98-baff-2703b83d7526	2023-12-05	Warnings	Exact identifier application number: M012
Stona-S	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc1	2023-12-04	Warnings	Exact identifier application number: M012
Stona Cough	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Sato Pharmaceutical Co., Ltd.	afc95c82-18da-487b-b4bb-51e0be0378da	2023-12-04	Warnings	Exact identifier application number: M012
No Drip Nasal Mist	OXYMETAZOLINE SPRAY	Walgreens Company	a14643a1-3d91-491a-88d6-22dccde97938	2023-12-04	Warnings	Exact identifier application number: M012
TopCare Day Time SEVERE Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Topco Associates LLC	14d53907-a4a2-4a0f-b2d6-33474945f9e1	2023-12-04	Warnings	Exact identifier application number: M012
Banophen	DIPHENHYDRAMINE HCL	Proficient Rx LP	62934d0f-b23d-4c03-9d60-a7bad41f9b42	2023-12-01	Warnings	Exact identifier application number: M012
Benadryl	DIPHENHYDRAMINE HYDROCHLORIDE	Proficient Rx LP	b1c849e5-8003-4fd3-811d-6a927523e353	2023-12-01	Warnings	Exact identifier application number: M012
Akin Expectorant Formula Strawberry Banana	GUAIFENESIN	Southern Sales & Service, Inc.	b63b0133-d2da-432b-a154-9e77535bbef9	2023-11-29	Warnings	Exact identifier application number: M012
Akin Cough Formula DM Strawberry Banana	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Southern Sales & Service, Inc.	7a81efd8-775d-455e-860f-f3e3b369a0a7	2023-11-29	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