FDA.reportPublic FDA data

Childrens Robitussin Cough Long-Acting

Product NDC
0031-8694
11-digit product format
000318694
Labeler code
0031
Product ID
0031-8694_13de389a-3701-8e4c-e063-6294a90a2587
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE
Active strength
7.5 mg/5mL
Pharmacologic classes
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 Long-Acting
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE7.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1370211Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75bc7827-4439-e6a8-a65c-7154d5592e58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8694-12Childrens Robitussin Cough Long-Acting1 in 1 CARTONLIQUID110
0031-8694-12Childrens Robitussin Cough Long-Acting118 mL in 1 BOTTLELIQUID11810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8694-12ML - Milliliter0031-8694d2d8fc96-c53c-40a2-8860-5710da27138012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
PROPYLENE GLYCOL, (R)-INACTIVE INGREDIENT602HN5L69HCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [RICHMOND DIVISION OF WYETH]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8694CHILDRENS ROBITUSSIN COUGH LONG-ACTING (DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 2 package rows20240318_75bc7827-4439-e6a8-a65c-7154d5592e58.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 12 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRRite Aid Corporation20af2586-f8ac-47a3-9f8d-de255f9193282026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRFamily Dollar Services Inc74ee96f7-75ac-4b60-a2b8-13b050e238042026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRDOLGENCORP, LLC7a662caf-9cbb-4d55-b0b2-43f1f1289ec72026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu Daytime, Nighttime, Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company4d199dc7-253f-48fd-a77d-f8b10f724dd12026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012
Mucus Relief DGUAIFENESIN, PSEUDOEPHEDRINE HCLMeijer Distribution Inc383281d7-0d25-4423-ace2-d2985f2c37d02026-08-03WarningsExact identifier
application number: M012
equaline daytime and nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI8fc2389c-9657-4dbe-a32b-df8245fc67ca2026-08-03WarningsExact identifier
application number: M012
Acetominophen, Dextromethorphan hydrobromideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDESoftgel Healthcare Private Limited5302bc6d-d947-31c3-e063-6294a90a09f32026-08-03WarningsExact identifier
application number: M012
MUCINEX INSTASOOTHE COUGHDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC0d99237c-0b52-0af6-e063-6394a90aba142026-08-03WarningsExact identifier
application number: M012
daytime nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company182a105b-bd49-42b5-b4e0-46e5ec0197e32026-08-03WarningsExact identifier
application number: M012
equaline nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEUnited Natural Foods, Inc. dba UNFI05e089e7-8772-4bf4-914f-6a26067ee7192026-08-03WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEMajor Pharmaceuticals66b918d3-5c37-4889-b981-819ced8b61472026-08-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370211dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN75bc7827-4439-e6a8-a65c-7154d5592e5810
1370211dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD75bc7827-4439-e6a8-a65c-7154d5592e5810
1370211dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY75bc7827-4439-e6a8-a65c-7154d5592e5810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8694-12000318694121 BOTTLE in 1 CARTON (0031-8694-12) / 118 mL in 1 BOTTLE1 bottle2015-07-010000-00-00NoNoCurrent