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 137 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	Topco Associates LLC	a2929bcb-fa81-4f15-b087-a9996b5e7d1f	2024-11-13	Warnings	Exact identifier application number: M012
Equate Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Walmart	6271bb48-74b2-eb57-e053-2991aa0afd1b	2024-11-13	Warnings	Exact identifier application number: M012
Equaline Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	United Natural Foods, Inc. dba UNFI	6bf341e0-94b1-08ff-e053-2991aa0af634	2024-11-13	Warnings	Exact identifier application number: M012
Good Sense Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Good Sense	cd25e250-bb8b-7e83-e053-2a95a90a2639	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd	440a00b1-7960-0cc4-e054-00144ff8d46c	2024-11-13	Warnings	Exact identifier application number: M012
Top Value Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Tower Laboratories Ltd.	c6f207e8-bc0d-853a-e053-2a95a90ac623	2024-11-13	Warnings	Exact identifier application number: M012
Effervescent Orange Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7fad8e65-34fe-5313-e053-2a91aa0a56f4	2024-11-13	Warnings	Exact identifier application number: M012
Dollar General Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE	DOLGENCORP, LLC	7face5c7-f5c7-7eee-e053-2991aa0ab064	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief Plus	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	90622927-9682-4eb0-8c7f-894230b3dda4	2024-11-13	Warnings	Exact identifier application number: M012
Quality Choice Effervescent Cold Relief - Orange	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE	Chain Drug Marketing Association	9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca	2024-11-13	Warnings	Exact identifier application number: M012
WinCo Foods Effervescent Cold Relief	ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE	WinCo Foods, LLC	d443a030-d3d6-40e0-8fe0-329de6bc494f	2024-11-13	Warnings	Exact identifier application number: M012
careone tussin dm	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	American Sales Company	954fe703-9a10-4354-8b71-4d98a22a0b9f	2024-11-13	Warnings	Exact identifier application number: M012
NASAL DECONGESTANT PE	PHENYLEPHRINE HCL	A-S Medication Solutions	9d030767-dfd6-48b4-9b17-4e20c23915f3	2024-11-13	Warnings	Exact identifier application number: M012
Childrens SUDAFED PE Cold plus Cough	DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE	Kenvue Brands LLC	20e45243-3989-413a-bcf1-49d754ff2e44	2024-11-12	Warnings	Exact identifier application number: M012
Tukol Cough And Cold Honey Flavor	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Genomma Lab USA	a4b333dc-58da-45db-87b6-6fcb8fb542b8	2024-11-12	Warnings	Exact identifier application number: M012
daytime nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	4b49137c-8fc9-43b7-b1a1-82e318237eb6	2024-11-12	Warnings	Exact identifier application number: M012
CVS Original Nasal Mist	OXYMETAZOLINE HCL	CVS PHARMACY, INC	e9c551a0-cd78-4272-b42f-36c096d26736	2024-11-12	Warnings	Exact identifier application number: M012
up and up cough plus chest congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Target Corporation	ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c	2024-11-12	Warnings	Exact identifier application number: M012
DG Health Cold and Flu Severe	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Dolgencorp Inc	b33d104b-0b4d-40c6-8345-c2c740327331	2024-11-11	Warnings	Exact identifier application number: M012
Zephrex D	PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	5468a7e2-361b-494f-9ca3-1b62f3819f65	2024-11-11	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