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 114 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING	CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR	Haleon US Holdings LLC	becb4025-b63e-f2ea-9d11-d51fdf4e5c13	2025-06-04	Warnings	Exact identifier application number: M012 ndc (product): 0031-8693
Diphenhydramine HCL STRAWBERRY FLAVOR	DIPHENHYDRAMINE HCL	Innovida Pharmaeutique Corporation	7eb709a5-c587-4f1d-bc2d-576d07a3a3bf	2025-06-04	Warnings	Exact identifier application number: M012
Children Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	TARGET CORPORATION	69d33f77-06e1-48fa-a516-892fdf11bb1c	2025-06-03	Warnings	Exact identifier application number: M012
oxymetazoline hydrochloride	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	fd058e2b-5445-e416-e053-6394a90a611b	2025-06-03	Warnings	Exact identifier application number: M012
Major Nasal Decongestant	OXYMETAZOLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	36b1a7e0-c8b9-0890-e063-6394a90ab13a	2025-06-03	Warnings	Exact identifier application number: M012
COLD, FLU and SORE THROAT RELIEF	ACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MG	BETTER LIVING BRANDS, LLC	202d60a8-83da-5afc-e063-6394a90ad779	2025-05-31	Warnings	Exact identifier application number: M012
Allergy Relief	DIPHENHYDRAMINE HCL	TARGET CORPORATION	f935341f-1e33-d78e-e053-6294a90a348e	2025-05-30	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	AARNA USA INC.	365bb414-8425-a900-e063-6394a90aa887	2025-05-30	Warnings	Exact identifier application number: M012
Childrens Allergy	DIPHENHYDRAMINE HYDROCHLORIDE	P & L Development, LLC	8559be55-8b00-4353-8e26-b5dff2ada806	2025-05-30	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Walmart Inc.	35da8429-1f83-9e81-e063-6294a90a3515	2025-05-23	Warnings	Exact identifier application number: M012
MAXIMUM STRENGTH COLD AND FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	TARGET CORP	9dfef3dc-dbc8-659a-e053-2995a90a8c3b	2025-05-21	Warnings	Exact identifier application number: M012
Adult Tussin	GUAIFENESIN	Camber Consumer Care	896d2540-279a-4405-b176-acbff56303e5	2025-05-20	Warnings	Exact identifier application number: M012
Nuvicare NightTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	NUVICARE LLC	37a88914-6234-4191-86f5-103c396c52af	2025-05-20	Warnings	Exact identifier application number: M012
Nuvicare DayTime Cold and Flu Softgel	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	NUVICARE LLC	1ea15426-4f3d-4a97-a590-6bd73bc6cbcd	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	3833e781-f6ee-4c6d-8756-d8ea2293a1f2	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choice Nasal Mist Severe Congestion	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	d45e99e5-ce66-4458-8d23-63a5dc7ae509	2025-05-19	Warnings	Exact identifier application number: M012
Quality Choicel Nasal Mist Extra Moisturizing	OXYMETAZOLINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	460f0cc1-6a85-4d79-af87-a94fd151769e	2025-05-19	Warnings	Exact identifier application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Combo Pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR	Haleon US Holdings LLC	812a093f-cf83-4f7a-927a-1b5695be7f90	2025-05-19	Warnings	Exact identifier application number: M012
MUCUS RELIEF	GUAIFENESIN	SDA Laboratories, Inc.	1fd16b06-0c3e-4a30-ae6a-7b1632189c20	2025-05-16	Warnings	Exact identifier application number: M012
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	Akron Pharma Inc.	79a6b8c7-0e81-4a46-a854-31f449042709	2025-05-16	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