Childrens Robitussin Nighttime Cough Long-Acting DM

Product NDC: 0031-8692
11-digit product format: 000318692
Labeler code: 0031
Product ID: 0031-8692_13dfb324-3f9f-0869-e063-6294a90a0770
Type: HUMAN OTC DRUG
Nonproprietary name: chlorpheniramine maleate, dextromethorphan hydrobromide
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-07-01
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 Nighttime Cough Long-Acting DM
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
8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	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
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0031-8692-13	2024-01-30	C162847	48780-1	1030e365-466d-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8692-13	Childrens Robitussin Nighttime Cough Long-Acting DM	118 mL in 1 BOTTLE	SOLUTION	118		10
0031-8692-13	Childrens Robitussin Nighttime Cough Long-Acting DM	1 in 1 CARTON	SOLUTION	1		10
0031-8692-13	RobitussinDay and Night Cough Relief Value Pack	118 mL in 1 BOTTLE	SOLUTION	118 mL	15 mg in 10mL	1
0031-8692-13	RobitussinDay and Night Cough Relief Value Pack	1 in 1 CARTON	SOLUTION		2 mg in 10mL	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8692-13	ML - Milliliter	0031-8692	1a8ba2cf-a8a1-4906-8aeb-9c0d982f096b	1	2019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
DEXTROMETHORPHAN HYDROBROMIDE	ACTIVE INGREDIENT	9D2RTI9KYH	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
DEXTROMETHORPHAN	ACTIVE MOIETY	7355X3ROTS	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RICHMOND DIVISION OF WYETH]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8692	CHILDRENS ROBITUSSIN NIGHTTIME COUGH LONG-ACTING DM (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [HALEON US HOLDINGS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240318_8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c.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 29 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	db264d2f-bf81-4da2-8595-2bfa1e4ba2f1	2026-05-18	Warnings	Exact identifier application number: M012
equate nighttime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	b8fc9b0e-8ab7-46e6-9fd9-18f8d4a14b5c	2026-05-15	Warnings	Exact identifier application number: M012
good neighbor pharmacy cold and cough	BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amerisource Bergen	da91e6b6-32ff-44fd-afce-33ea9549554b	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	847cdee8-410f-4ff3-9245-976ed6f4c776	2026-05-15	Warnings	Exact identifier application number: M012
Antihistamine	DIPHENHYDRAMINE HCL	Gendose Pharmaceuticals, LLC	d3b2f300-d919-44cd-ab71-b74b5bdfd977	2026-05-15	Warnings	Exact identifier application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER	ACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDS	MEDWISE LIFESCIENCES INC.	51d52ce4-98c4-2b9b-e063-6294a90ade44	2026-05-15	Warnings	Exact identifier application number: M012
Curewell Tussin DM	DEXTROMETHORPHAN, GUAIFENESIN	RMT HEALTH LLC	4fe9ad93-cdc4-b4df-e063-6294a90a90ae	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Orchard Cherry	MENTHOL	Melaleuca, Inc.	6049842c-d763-4a91-a225-976ed74e1693	2026-05-15	Warnings	Exact identifier application number: M012
CounterAct Cough Drops Honey Lemon	MENTHOL	Melaleuca, Inc.	84ac3489-9d64-401f-ab78-715af4de5440	2026-05-15	Warnings	Exact identifier application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast Gels	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE	Bayer HealthCare LLC.	51e03b5b-b05a-07c1-e063-6394a90ab201	2026-05-15	Warnings	Exact identifier application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/Daytime	ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL	Rite Aid Corporation	38d73a1e-ac78-4f67-9291-bb48ab80306e	2026-05-15	Warnings	Exact identifier application number: M012
Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR	WALMART INC.	071615ba-f50a-4d2a-a358-43140bccce72	2026-05-14	Warnings	Exact identifier application number: M012
Severe Cold and Flu Nighttime Daytime	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	HyVee Inc	d4bcfabb-a054-4f53-8dc9-d361a03558b8	2026-05-14	Warnings	Exact identifier application number: M012
Cough and Chest Congestion DM Adult	DEXTROMETHORPHAN HBR, GUAIFENESIN	CVS Pharmacy	4444c05a-eba6-4633-b86f-34f455699fa9	2026-05-14	Warnings	Exact identifier application number: M012
Topcare Day Time Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Topco Associates LLC	a88e5b8e-e6dd-4a1c-9628-5861d3205bdb	2026-05-14	Warnings	Exact identifier application number: M012
equate daytime cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Wal-Mart Stores Inc	69b24c67-cf4b-46d7-a44b-d1917cc876b1	2026-05-14	Warnings	Exact identifier application number: M012
GILTUSS DIABETIC EX	GILTUSS DIABETIC EX	Gil Pharmaceutical Corp	ab7915e7-323a-4fe1-887a-a3bd3f0aac98	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Maximum Strength Expectorant	GILTUSS EX MAXIMUM STRENGTH EXPECTORANT	Gil Pharmaceutical Corp	950db1ca-6936-47f8-a112-e3594d4c922c	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GILTUSS EX EXPECTORANT	Gil Pharmaceutical Corp	3b363fb9-c4d3-446f-927c-f705ffc715b5	2026-05-13	Warnings	Exact identifier application number: M012
Giltuss HBP EX Expectorant	GILTUSS HBP EX EXPECTORANT	Gil Pharmaceutical Corp	31bd6356-27cf-4188-8fd5-9cd9392021ca	2026-05-13	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	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	10
1111440	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	10
1111440	chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution	SY	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	10
1111440	chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	8a8380f4-fa8a-4cca-8b8f-f8d7c5a33f9c	10
2362250	{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) } Pack	GPCK	4029eccd-5443-4ae2-9232-2a1d922798f8	1
2362250	1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 20 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) Pack	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral Solution	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution	SCD	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	4029eccd-5443-4ae2-9232-2a1d922798f8	1
2362250	1 daytime (dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) Pack	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1111440	chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	4029eccd-5443-4ae2-9232-2a1d922798f8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8692-13	00031869213	1 BOTTLE in 1 CARTON (0031-8692-13) / 118 mL in 1 BOTTLE	1 bottle	2014-07-01	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	1
Drug Facts	Haleon US Holdings LLC	2024-03-17	HUMAN OTC DRUG LABEL	10