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 159 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	4c6b6379-3a7f-4507-a792-7b69a7f3ba82	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	04defcf6-e20e-402b-b725-d9394a0146b1	2024-07-16	Warnings	Exact identifier application number: M012
basic care allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	7d237d37-21c7-476d-a8b7-d91ea1b472ee	2024-07-16	Warnings	Exact identifier application number: M012
Berkley and Jensen Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC	b52fc311-8853-4116-941b-8be35456abba	2024-07-16	Warnings	Exact identifier application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	0b9a4438-7d13-484c-a614-2dedc24974dc	2024-07-16	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Publix Super Markets Inc	23a98385-28cc-4fac-8c87-b3ced8106532	2024-07-16	Warnings	Exact identifier application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe	0.05% OXYMETAZOLINE	Walgreens Company	aad01028-cbe0-4c10-adbc-d157bfa5af09	2024-07-16	Warnings	Exact identifier application number: M012
Basic Care severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	924bf427-b054-46af-b341-ff162946cd58	2024-07-15	Warnings	Exact identifier application number: M012
Maximum Strength Cold Tabs	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	JHK DBA American Safety & First Aid	e7d4fe9a-eb09-4266-90c9-290f61ce6ad0	2024-07-15	Warnings	Exact identifier application number: M012
ACTIDOM DA	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2024-07-15	Warnings	Exact identifier application number: M012
Nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1cf3064d-4ddd-63b9-e063-6294a90aa547	2024-07-11	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	TARGET CORPORATION	1ccbdb53-3f70-28da-e063-6394a90a9ae0	2024-07-09	Warnings	Exact identifier application number: M012
AXIV Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1cd2a6f1-31ad-e507-e063-6394a90aba58	2024-07-09	Warnings	Exact identifier application number: M012
Poly Hist Forte	DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aa0015b-8fc1-7951-e053-2a95a90a8e72	2024-07-09	Warnings	Exact identifier application number: M012
DECONEX DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aab8e5c-1633-2e5a-e053-2a95a90adcc5	2024-07-09	Warnings	Exact identifier application number: M012
Deconex IR	GUAIFENESIN AND PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	4710095e-3dae-4a39-8a98-873012e1f003	2024-07-09	Warnings	Exact identifier application number: M012
Diabetic Tussin Sore Throat and Cough Cherry	BENZOCAINE AND DEXTROMETHORPHAN HBR	MEDTECH PRODUCTS INC	e9327079-e0fc-4c95-b1d5-bc1b74870c9b	2024-07-09	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	fac859a4-e23a-4879-af6c-26368455506d	2024-07-05	Warnings	Exact identifier application number: M012
Severe Throat Drops	MENTHOL ICE	Target Corporation Inc.	1876b221-fa60-5269-e063-6394a90a6963	2024-07-04	Warnings	Exact identifier application number: M012
Daytime and Nighttime Cherry Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0bf911bf-eafe-fe46-e063-6294a90a3903	2024-07-03	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