FDA.reportPublic FDA data

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
IngredientStrength
CHLORPHENIRAMINE MALEATE2 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE15 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V1Q0O9OJ9ZInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
becb4025-b63e-f2ea-9d11-d51fdf4e5c13Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0031-8693-122024-01-30C16284748780-11030e365-4686-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8693-12CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING1 in 1 CARTONLIQUID16
0031-8693-12CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING118 mL in 1 BOTTLELIQUID1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8693-12ML - Milliliter0031-86933302060a-7976-4ecc-a629-d69e9fa62c1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
chlorpheniramine maleateACTIVE INGREDIENTV1Q0O9OJ9ZCHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHCHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
chlorpheniramineACTIVE MOIETY3U6IO1965UCHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [RICHMOND DIVISION OF WYETH]1
dextromethorphanACTIVE MOIETY7355X3ROTSCHILDRENS 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
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8693CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTING (CHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBR) LIQUID [HALEON US HOLDINGS LLC]5Current NDC, Legacy NDC, 2 package rows20240316_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 100 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho CFBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDextrum Laboratories, Inc401a97af-36ae-4e54-e063-6294a90ab3ee2025-10-01WarningsExact identifier
application number: M012
NyQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Company724d0889-5ba5-3125-e053-2a91aa0a92c12025-10-01WarningsExact identifier
application number: M012
DayQuil Severe plus Vicks VapoCool Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company724f2833-34bd-6a9e-e053-2991aa0a073d2025-10-01WarningsExact identifier
application number: M012
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEInvaTech Pharma Solutions LLCb8d360fa-0d80-f6a8-e053-2a95a90a8bd42025-10-01Exact identifier
application number: M012
LEADER TUSSIN CFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCardinal Health 110, LLC. dba Leaderf4ffe87b-0a62-44ac-b84a-08cf77cda7f52025-10-01WarningsExact identifier
application number: M012
Nasal Spray, 1oz, 24/7 Life by 7-ElevenOXYMETAZOLINE HCL NASAL SOLUTION 0.05%Lil' Drug Store Products, Inc.3e781417-9ffc-f2c9-e063-6294a90a72052025-09-30WarningsExact identifier
application number: M012
Original Extra Strong All Natural Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.d8f4a65b-cf2c-4424-b27f-e3e0ffadd9cf2025-09-30WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3ff240ba-90b2-4c17-e063-6394a90ac56f2025-09-29WarningsExact identifier
application number: M012
DometussCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc3fcace53-a81f-e774-e063-6294a90a32fa2025-09-27WarningsExact identifier
application number: M012
nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf6a3680a-3ac6-4fd4-be52-ce29064c4aa12025-09-26WarningsExact identifier
application number: M012
No Drip Severe Nasal MistOXYMETAZOLINE SPRAYCVS Health9d9f6c03-0ae1-4f3b-80cd-b23b7c4bdae52025-09-26WarningsExact identifier
application number: M012
Giltuss Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa0b3be-2124-ed1d-e063-6294a90aaf482025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3fa17255-514f-db47-e063-6294a90ae4542025-09-25WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa17272-fd7f-9ab4-e063-6394a90a585f2025-09-25WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINXiamen Kang Zhongyuan Biotechnology Co., Ltd.3fa2e438-2ff3-a2df-e063-6394a90ac7b52025-09-25WarningsExact identifier
application number: M012
QUALITY CHOICE ADULT TUSSIN EXPECTORANTGUAIFENESINQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)63dad603-fe2f-42a6-a626-5c8048a42c102025-09-25WarningsExact identifier
application number: M012
Giltuss Childrens Allergy PlusCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEDextrum Laboratories Inc.3fa5220f-38bb-9ef6-e063-6294a90aeff82025-09-25WarningsExact identifier
application number: M012
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME)ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHealth Pharma USA LLCa03befb4-d86d-43e4-8097-eda5c8bb25be2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss EX ExpectorantGUAIFENESINDextrum Laboratories Inc.3f8d7d47-f14c-888c-e063-6394a90a5cdd2025-09-24WarningsExact identifier
application number: M012
Childrens Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINDextrum Laboratories, Inc3f909bc2-eb84-a19d-e063-6294a90ae04e2025-09-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSNbecb4025-b63e-f2ea-9d11-d51fdf4e5c136
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCDbecb4025-b63e-f2ea-9d11-d51fdf4e5c136
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSYbecb4025-b63e-f2ea-9d11-d51fdf4e5c136
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSYbecb4025-b63e-f2ea-9d11-d51fdf4e5c136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8693-12000318693121 BOTTLE in 1 CARTON (0031-8693-12) / 118 mL in 1 BOTTLE1 bottle2004-01-010000-00-00NoNoCurrent