FDA.reportPublic FDA data

Childrens Robitussin Cough and Cold CF

Product NDC
0031-8716
11-digit product format
000318716
Labeler code
0031
Product ID
0031-8716_13de3a9e-573f-846a-e063-6294a90a53c9
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-09-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 50; 2.5 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 CF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
GUAIFENESIN50 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1370205Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcd0a8e0-ac2a-039a-be3c-534195d6bcfdAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0031-8716-122024-01-30C16284748780-11030e365-322c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8716-12Childrens Robitussin Cough and Cold CF118 mL in 1 BOTTLELIQUID11811
0031-8716-12Childrens Robitussin Cough and Cold CF1 in 1 CARTONLIQUID111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8716-12ML - Milliliter0031-87169013f2a7-98f7-4ea4-8376-e274dde56d2612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
GUAIFENESINACTIVE INGREDIENT495W7451VQCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
GUAIFENESINACTIVE MOIETY495W7451VQCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SORBITOLINACTIVE INGREDIENT506T60A25RCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [RICHMOND DIVISION OF WYETH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8716CHILDRENS ROBITUSSIN COUGH AND COLD CF (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 2 package rows20240318_fcd0a8e0-ac2a-039a-be3c-534195d6bcfd.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 9 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rolaids Ultra Strength MintCALCIUM CARBONATE AND MAGNESIUM HYDROXIDEChattem, Inc.8806c912-ab83-4f45-ac78-e826bb3143d42026-01-14WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Wild BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.07649a83-0123-4bb5-b130-3067c7d052c52026-01-14WarningsExact identifier
application number: M001
CVS Health Extra Strength Sugar Free AntacidANTACIDCVS Pharmacy,Inc.f722e7ce-6cca-4850-a230-7510c7ca77542026-01-12WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e1a46c-5665-ac4c-e063-6294a90a9b812026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted FruitsCALCIUM CARBONATEMedical Group Care LLC47e19b30-3784-ad98-e063-6294a90aa5662026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Tropical FruitCALCIUM CARBONATEMedical Group Care LLC47e1bc32-baf5-ad9a-e063-6294a90ad5b42026-01-08WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEMedical Group Care LLC47e1c7c7-4f3b-c04b-e063-6394a90a775f2026-01-08WarningsExact identifier
application number: M001
Sanar Baking Soda 8oz 100% pureSODIUM BICARBONATEEvi Labs47e7f801-3176-288c-e063-6394a90abef42026-01-08WarningsExact identifier
application number: M001
Xpect AntacidCALCIUM CARBONATECintas Corporation3ef4eac7-cc9d-4ee2-b93a-59b85dbc6e7c2026-01-08WarningsExact identifier
application number: M001
DR. SANA BICARBONATO DE SODIO 4 Fl oz and 6 FlozSODIUM BICARBONATEEvi Labs47330d09-7db1-254d-e063-6294a90ae7de2026-01-07WarningsExact identifier
application number: M001
DE LA CRUZ SODIUM BICARBONATE ANTACIDSODIUM BICARBONATEDLC Laboratories, Inc.fc469943-9749-45ee-93f7-90fdbcdc72152026-01-07WarningsExact identifier
application number: M001
De La Cruz DesempachoSODIUM BICARBONATEDLC LABORATORIES, INC.741e105a-3ed2-4fc7-ab06-273e515a2d162026-01-07WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472eafe8-aa7a-f435-e063-6294a90acf6b2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472f5bfc-c676-56da-e063-6294a90a74af2025-12-30WarningsExact identifier
application number: M001
ANTACID AND ANTIGASCALCIUM CARBONATE, MAGNESIUM HYDROXIDE, SIMETHICONEGeri-Care Pharmaceuticals, Corp472ffa66-938f-14e7-e063-6394a90ad0ca2025-12-30WarningsExact identifier
application number: M001
QC Ultra Strength Antacid Soft Chews, CherryQC ANTACID SOFT CHEWS, CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.26a97517-d3e7-d896-e063-6394a90acc952025-12-29WarningsExact identifier
application number: M001
Tums Chewy BitesCALCIUM CARBONATESelect Consumer Group3caa037e-3424-f9ce-e063-6294a90ac1e82025-12-27WarningsExact identifier
application number: M001
AntacidANTACIDXiamen Kang Zhongyuan Biotechnology Co., Ltd.17adb983-bb28-bf8b-e063-6394a90a7daa2025-12-26WarningsExact identifier
application number: M001
Sodium Bicarbonate 10 grSODIUM BICARBONATEGRAXCELL PHARMACEUTICAL, LLC897dbb09-fb47-4e03-8cae-bf76d48a7a032025-12-25WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEH-E-B3f9f6560-312f-44b7-e063-6394a90a1c562025-12-24WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370205dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSNfcd0a8e0-ac2a-039a-be3c-534195d6bcfd11
1370205dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCDfcd0a8e0-ac2a-039a-be3c-534195d6bcfd11
1370205dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral SolutionSYfcd0a8e0-ac2a-039a-be3c-534195d6bcfd11
1370205dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSYfcd0a8e0-ac2a-039a-be3c-534195d6bcfd11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8716-12000318716121 BOTTLE in 1 CARTON (0031-8716-12) / 118 mL in 1 BOTTLE1 bottle2009-09-010000-00-00NoNoCurrent