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 143 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DoloMax Cold Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	BENARD INDUSTRIES INC	520aee75-8b9a-4dcc-8970-75e122640e91	2024-10-31	Warnings	Exact identifier application number: M012
Good Sense Nasal	OXYMETAZOLINE HYDROCHLORIDE	A-S Medication Solutions	b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe	2024-10-31	Warnings	Exact identifier application number: M012
CareOne Nighttime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	American Sales Company	819d5c82-0240-4013-9904-c335bd65d03e	2024-10-30	Warnings	Exact identifier application number: M012
Signature Care Nighttime Severe Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Safeway	9a0ad5d5-8fd9-468d-be2c-87c14d08b934	2024-10-30	Warnings	Exact identifier application number: M012
Good Sense Severe NightTime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	L. Perrigo Company	f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2	2024-10-30	Warnings	Exact identifier application number: M012
dg health cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Dolgencorp, LLC	81f3ac36-9bae-4f42-92a0-8a2e4bbd0984	2024-10-30	Warnings	Exact identifier application number: M012
severe cold and flu relief	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Rite Aid Corporation	9a71e8eb-4195-4694-bf3e-44f691ff2cef	2024-10-30	Warnings	Exact identifier application number: M012
nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	H E B	fe4a95d2-6fb3-43fe-baec-6f22d1965323	2024-10-30	Warnings	Exact identifier application number: M012
NightTime Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Kroger Company	2c9ef0d7-3d5b-494a-8f06-9dd42110d78a	2024-10-30	Warnings	Exact identifier application number: M012
Severe Nighttime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	CVS Pharmacy	d40d6fd1-3f84-40ae-ab7e-04569eb41617	2024-10-30	Warnings	Exact identifier application number: M012
equaline nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	United Natural Foods, Inc. dba UNFI	4e0c6ad6-81ef-4b0e-b2eb-44256faf7358	2024-10-30	Warnings	Exact identifier application number: M012
GOOD REMEDIES Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fbe2c0-7749-4c8a-e063-6394a90a7c6e	2024-10-30	Warnings	Exact identifier application number: M012
basic care nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	130e68d1-9048-49c1-beee-490eecaed2d9	2024-10-30	Warnings	Exact identifier application number: M012
Severe Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Walgreen Company	02f3e739-3153-412f-b2cd-6f01dcd5875b	2024-10-30	Warnings	Exact identifier application number: M012
HealthWise Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	25a19d3e-37b3-50d5-e063-6394a90a97d1	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23a03-6110-f595-e063-6394a90a70fe	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Cough and Cold	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Pharmadel LLC	25a23e5e-302a-7b7f-e063-6294a90a0463	2024-10-29	Warnings	Exact identifier application number: M012
Antigrip Extra Strength	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	Pharmadel LLC	25a26adf-fd90-bf57-e063-6294a90a4073	2024-10-29	Warnings	Exact identifier application number: M012
Menthol Cough Drops	MENTHOL	BOSTON NUTRACEUTICAL PRODUCTION, S.L	e82dac83-2910-44dc-e053-2995a90a38e1	2024-10-29	Warnings	Exact identifier application number: M012
TheraCare Medicated Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Veridian Healthcare	d6e789c7-a55a-dc9a-e053-2a95a90a2bdb	2024-10-29	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