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 28 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Mucus Cough and Congestion ReliefDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company8b5d391b-6c23-44c3-81d0-c08822bf6d012026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Night Time Multi-Symptom ColdACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCe048cd53-a3cd-484f-a972-4cb49791dba32026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens CoughDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCb8132c81-5291-431a-ad3a-ec8a3eb21c192026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC7354f57c-0ecf-481f-9482-0040c90c43502026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC5bda415d-739f-4ca5-b5b2-07c14a81863b2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom Cold and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC8f3eb5c5-832e-4806-b3da-ef112cf55dcf2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Night Time Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AND DIPHENHYDRAMINE HYDROCHLORIDEReckitt Benckiser LLCe3aea6df-37a4-43c5-a192-a902cbff3f922026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLCd9e5a8d7-814c-4ab1-bb05-e4cb9155978e2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Day Time Multi-Symptom Cold and Mucinex Childrens Night Time Multi-Symptom Cold Triple PackACETAMINOPHEN, DIPHENYLHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESINReckitt Benckiser LLCc7ab5201-8550-4bf4-957c-c8f049aeaa4a2026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC84e7be8f-2785-45ef-9c44-de05394fcd992026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC771d7fd8-184f-48a3-90ed-e8f00159d97e2026-05-18WarningsExact identifier
application number: M012
MUCINEX Childrens Stuffy NoseOXYMETAZOLINE HYDROCHLORIDEReckitt Benckiser LLCde1c0abd-1644-4351-8106-e9df6ca5c1422026-05-18WarningsExact identifier
application number: M012
Mucinex Childrens Fever Sore Throat and CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC1538a75d-582a-9501-e063-6394a90a6c552026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC19105007-0193-0764-e063-6294a90a01a42026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Kickstart Severe Congestion and Cough and Mucinex Fast-Max Nighttime Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, ACETAMINOPHEN,TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC34fd2458-9acd-cdf7-e063-6394a90a3d0a2026-05-18WarningsExact identifier
application number: M012
MUCINEX FAST-MAX NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC3a24b06c-00a6-c2ef-e063-6294a90a4d722026-05-18WarningsExact identifier
application number: M012
Mucinex Fast-Max Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINReckitt Benckiser LLC14be3ab0-d6ae-e342-e063-6294a90ab8512026-05-18WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLBryant Ranch Prepack20f00537-2c8a-45d1-8e5f-ec276d0a47b62026-05-18WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLL.N.K. International, Inc.38df2308-f6f9-4476-ad34-4b5bc5f9fdf22026-05-18WarningsExact identifier
application number: M012
Allergy Plus Headache ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.88e3b969-79d0-4e64-95c0-c5cfd41e365f2026-05-18WarningsExact 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