CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING

Product NDC: 0031-8693
11-digit product format: 000318693
Labeler code: 0031
Product ID: 0031-8693_1511b29b-fd49-44fd-aff1-89809fb6c971
Type: HUMAN OTC DRUG
Nonproprietary name: chlorpheniramine maleate, dextrometrorphan HBr
Dosage form: LIQUID
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2004-01-01
Substance: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 2; 15 mg/10mL; mg/10mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 COLD LONG-ACTING
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORPHENIRAMINE MALEATE	2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V1Q0O9OJ9Z	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1111440	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
becb4025-b63e-f2ea-9d11-d51fdf4e5c13	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0031-8693-12	2024-01-30	C162847	48780-1	1030e365-4686-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8693-12	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	1 in 1 CARTON	LIQUID	1		6
0031-8693-12	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	118 mL in 1 BOTTLE	LIQUID	118		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8693-12	ML - Milliliter	0031-8693	3302060a-7976-4ecc-a629-d69e9fa62c1c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
chlorpheniramine maleate	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]	1
dextromethorphan hydrobromide	ACTIVE INGREDIENT	9D2RTI9KYH	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]	1
chlorpheniramine	ACTIVE MOIETY	3U6IO1965U	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]	1
dextromethorphan	ACTIVE MOIETY	7355X3ROTS	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8693	CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [HALEON US HOLDINGS LLC]	5	Current NDC, Legacy NDC, 2 package rows	20240316_becb4025-b63e-f2ea-9d11-d51fdf4e5c13.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 155 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Nasal	OXYMETAZOLINE HYDROCHLORIDE	Topco Associates LLC	f1dd78e0-f700-4469-85d6-18cc299e8746	2024-08-28	Warnings	Exact identifier application number: M012
equaline nasal	OXYMETAZOLINE HCL	United Natural Foods, Inc. dba UNFI	69308693-a094-42a9-a041-e73647a25cc1	2024-08-27	Warnings	Exact identifier application number: M012
signature care nasal decongestant	OXYMETAZOLINE HYDROCHLORIDE	Safeway	f9ac80d1-3753-412b-a407-18a6b50e5d1c	2024-08-27	Warnings	Exact identifier application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	20ac6010-84f4-eeff-e063-6294a90a50a7	2024-08-27	Warnings	Exact identifier application number: M012
Exchange Select Nasal	OXYMETAZOLINE HCL	Army & Air Force Exchange Service	40d2090d-c332-4dcb-9f43-5ee467e7b3d1	2024-08-27	Warnings	Exact identifier application number: M012
Signature Care Nasal Decongestant	OXYMETAZOLINE HCL	Safeway	23f0a5b3-59ae-4eb3-9b7d-e6a492060337	2024-08-27	Warnings	Exact identifier application number: M012
DG Health Nasal	OXYMETAZOLINE HYDROCHLORIDE	Dolgencorp, LLC	debcda99-c605-4941-b873-9e4dbae27483	2024-08-27	Warnings	Exact identifier application number: M012
Good Neighbor Pharmacy Nasal	OXYMETAZOLINE HCL	Amerisource Bergen	d374d697-2b57-4558-a20b-d3d89aea82d7	2024-08-27	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HCL	Meijer Distribution Inc	3984cbc3-b60c-40a7-bc3a-7d1f600503ac	2024-08-27	Warnings	Exact identifier application number: M012
foster and thrive nasal	OXYMETAZOLINE HYDROCHLORIDE	Strategic Sourcing Services LLC	e6e51821-03ae-4ec3-82a9-b4a8feacd996	2024-08-27	Warnings	Exact identifier application number: M012
Pyrilamine Maleate and Dextromethorphan Hydrobromide	PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE	Westminster Pharmaceuticals, LLC	dd068449-9d24-41e6-8a6e-f69c9fe263f2	2024-08-26	Warnings	Exact identifier application number: M012
basic care nasal	OXYMETAZOLINE HYDROCHLORIDE	Amazon.com Services LLC	a154e500-2b45-4242-a26c-9530849f99df	2024-08-23	Warnings	Exact identifier application number: M012
Daytime Nighttime Ultra Concentrated Cold and Flu	DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE	TARGET CORPORATION	0c0cf76f-2dd3-45ef-e063-6394a90a9fef	2024-08-22	Warnings	Exact identifier application number: M012
Day Cold and Flu and Night Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL	TARGET CORPORATION	08ee56d1-b11d-3e36-e063-6294a90acd5f	2024-08-22	Warnings	Exact identifier application number: M012
Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE	TARGET CORPORATION	0fc523ce-55a7-6384-e063-6394a90aad3f	2024-08-22	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Walgreens	8045aef9-22bc-4146-b494-dbb1ffef06df	2024-08-19	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION, INC.	5a2053d4-9c0d-4613-9cf5-0067173f3730	2024-08-16	Warnings	Exact identifier application number: M012
QUALITY CHOICE Long Acting Cough Softgel	DEXTROMETHORPHAN HYDROBROMIDE	Chain Drug Marketing Association, Inc.	f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c	2024-08-16	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Padagis Israel Pharmaceuticals Ltd	458594e1-8d99-4de3-8923-2fd8ce2fc406	2024-08-16	Warnings	Exact identifier application number: M012
Halls Sugar Free Mountain Menthol	MENTHOL	Mondelez Global LLC	54e0d57e-1f48-45e2-86b3-0e50775996f4	2024-08-15	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V1Q0O9OJ9Z	CHLORPHENIRAMINE MALEATE	113-92-8	CHLORPHENIRAMINE MALEATE
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1111440	chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution	PSN	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	6
1111440	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	6
1111440	chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution	SY	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	6
1111440	chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8693-12	00031869312	1 BOTTLE in 1 CARTON (0031-8693-12) / 118 mL in 1 BOTTLE	1 bottle	2004-01-01	0000-00-00	No	No	Current