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 49 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLMajor Pharmaceuticals7f2b72cc-d4f7-431f-be61-c103cf8c489e2026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
application number: M012
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALMART STORES INC18436026-b0e4-4481-a647-d735a27d0b002026-02-19WarningsExact identifier
application number: M012
VaporizingCAMPHORMeijer, Inc.7afc98d7-f64f-42d5-9022-28ad6b01db8a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEKroger Company8196b482-070e-4d7d-8943-129141f926ee2026-02-19WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy Chews BubblegumDIPHENHYDRAMINE HCLWALMART STORES INC9f83d2f0-9718-4f2b-bc7f-e29ba29174122026-02-19WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
application number: M012
Allergy Relief Dye-FreeDIPHENHYDRAMINE HCLCVS Pharmacy08459cf4-feb3-4283-88e1-d61e030c57f92026-02-19WarningsExact identifier
application number: M012
allergy reliefCHLORPHENIRAMINE MALEATERite Aid Corporationb0d70488-ea1d-4c1d-bd07-53dfb0e4d03c2026-02-18WarningsExact identifier
application number: M012
Walgreens Wild Cherry Pectin Throat DropsPECTINWalgreens424fda2d-c1e5-0ed9-e063-6394a90a06ea2026-02-18WarningsExact identifier
application number: M012
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEAmerisource Bergeneeda80ff-212d-428e-a0c6-782f271357b42026-02-18WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact 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