FDA.reportPublic FDA data

Childrens Robitussin Cough and Chest Congestion DM

Product NDC
0031-8715
11-digit product format
000318715
Labeler code
0031
Product ID
0031-8715_13dd51f2-2aca-082e-e063-6294a90a2f4f
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 100 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Chest Congestion DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9772292-9eb6-47cf-abb8-007c25478090Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8715-10Childrens Robitussin Cough and Chest Congestion DM118 mL in 1 BOTTLELIQUID11810
0031-8715-10Childrens Robitussin Cough and Chest Congestion DM1 in 1 CARTONLIQUID110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8715-10ML - Milliliter0031-8715cb73077e-99cb-436a-b62a-92eb36129faf12017-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [RICHMOND DIVISION OF WYETH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8715CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 2 package rows20240318_b9772292-9eb6-47cf-abb8-007c25478090.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 108 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cosedal DropsDEXTROMETHORPHAN HBR, GUAIFENESINMenper Distributors, Inc.1241d249-ea3b-4d2b-87ed-835d6a2d286a2025-07-22WarningsExact identifier
application number: M012
Berro y Cebolla DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMenper Distributors, Inc.20107bd9-6d84-4ab5-a0d9-966f1f11d9192025-07-22WarningsExact identifier
application number: M012
Defensol-itoDEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINEMenper Distributors, Inca7c7a60d-d49f-4239-92f7-714eac7eb0c52025-07-22WarningsExact identifier
application number: M012
Bisolvine ChildrenGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.896a5443-e3d2-4af7-9e27-f1c1899ce0382025-07-22WarningsExact identifier
application number: M012
Bisolvine Aloe-MielDEXTROMETHORPHAN, GUAIFENESINMENPER DISTRIBUTORS INC.34801c79-ce88-492f-808e-b639e86016072025-07-22WarningsExact identifier
application number: M012
Viva Porru Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILMenper Distributors, Inc.0dfadfe3-9e40-0eee-e063-6294a90a00c32025-07-22WarningsExact identifier
application number: M012
leader childrens allergy reliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. dba Leader40d697b7-dc59-4d24-8d46-db635e01b9d52025-07-22WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEChain Drug Consortium34005c55-3176-4f28-9a3b-7dc6fefd01fe2025-07-19WarningsExact identifier
application number: M012
Sinus Relief Daytime NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company73a77a13-983b-4e65-bb3c-2ba5e9f33a3e2025-07-19WarningsExact identifier
application number: M012
QUALITY CHOICE No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)7cb6ad04-7847-46b9-b371-0a3473001c792025-07-18WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLChain Drug Consortium270e9221-d305-4148-b523-741e02fe733f2025-07-18WarningsExact identifier
application number: M012
ACTISPEC PSEDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC5def1555-87f4-41d5-8a5c-be560aa8f1e22025-07-17WarningsExact identifier
application number: M012
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAYACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1a17b24a-8022-4e2f-e063-6294a90af2762025-07-17WarningsExact identifier
application number: M012
BULPOL Smoking PatchesMENTHOLJiashen International Trade Limited3a1cc0e1-fabf-52b9-e063-6394a90ae35e2025-07-17WarningsExact identifier
application number: M012
Ampigrin Ultra Forte NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e71c3-fe7c-77c7-e053-2995a90a34b22025-07-17WarningsExact identifier
application number: M012
NitecinACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCdfb56532-6f72-1e4d-e053-2a95a90a1c052025-07-17WarningsExact identifier
application number: M012
tabcin NIGHTACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLC0b3ed2bb-88ed-699e-e063-6394a90ac0232025-07-17WarningsExact identifier
application number: M012
Pentrexcilina Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe11e5c17-28f2-7186-e053-2995a90a51f62025-07-17WarningsExact identifier
application number: M012
Viro Flu PM ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEOPMX LLCe1553da8-3a89-e258-e053-2a95a90a47252025-07-17WarningsExact identifier
application number: M012
ACTICON PEDIATRICDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDEACTIPHARMA, LLC3052cc67-e6c0-4d3f-9ec9-ffe58d9fae232025-07-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb9772292-9eb6-47cf-abb8-007c2547809010
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb9772292-9eb6-47cf-abb8-007c2547809010
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb9772292-9eb6-47cf-abb8-007c2547809010
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb9772292-9eb6-47cf-abb8-007c2547809010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8715-10000318715101 BOTTLE in 1 CARTON (0031-8715-10) / 118 mL in 1 BOTTLE1 bottle2014-07-010000-00-00NoNoCurrent