FDA.reportPublic FDA data

Childrens Robitussin Honey Nighttime Cough DM

Product NDC
0031-8762
11-digit product format
000318762
Labeler code
0031
Product ID
0031-8762_350764de-7804-b24e-e063-6394a90ab3c3
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hbr, doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-27
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
15; 6.25 mg/10mL; mg/10mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Honey Nighttime Cough DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/10mL
DOXYLAMINE SUCCINATE6.25 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6afaf85b-bf0c-4c99-acf3-a34f06be20f1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8762-12Childrens Robitussin Honey Nighttime Cough DM118 mL in 1 BOTTLESOLUTION11811
0031-8762-12Childrens Robitussin Honey Nighttime Cough DM1 in 1 CARTONSOLUTION111
0031-8762-12RobitussinChildrens Honey Day Night DM Value Pack118 mL in 1 BOTTLESOLUTION1 mL15 mg in 10mL2
0031-8762-12RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONSOLUTION6.25 mg in 10mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8762-12ML - Milliliter0031-87626760d42d-7a3c-47dd-9c2a-f30d8cec6e4312025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8762CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]11Current NDC, Legacy NDC, 2 package rows20250515_6afaf85b-bf0c-4c99-acf3-a34f06be20f1.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 106 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Exchange Select Cough Drops Original HerbMENTHOLArmy & Air Force Exchange Service3d7109a5-4fe1-039b-e063-6394a90a13922025-08-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3d710deb-e42d-13eb-e063-6394a90a56e12025-08-28WarningsExact identifier
application number: M012
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
application number: M012
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
application number: M012
Adult Bisolvine AdultGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.8cde5e39-a338-45af-b847-3823627f29c52025-08-25WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
application number: M012
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLVerityRx9ca6c0f8-71d1-4953-8e98-3311c46640112025-08-22WarningsExact identifier
application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum StrengthPHENYLEPHRINE HCLSalado Sales, Inc.9056fa58-d6aa-4df5-97e0-9be3f2332f862025-08-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
application number: M012
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact identifier
application number: M012
MedPride Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLShield Line LLC85cd2fb8-d688-c3a3-e053-2991aa0ac18c2025-08-20WarningsExact identifier
application number: M012
Adult Cough and Chest Congestion Relief DM Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINSafeway, Inc.5bd508a0-2f75-413e-a690-bed970131bef2025-08-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEBJWC (Berkley & Jensen / BJ's)2f32d32e-e92c-ea57-e063-6394a90a4c392025-08-19WarningsExact identifier
application number: M012
Daytime Nighttime Cold Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLRite Aid Corporation0eff2050-2d15-40cf-b96d-666d1dd831202025-08-19WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRite Aid Corporation09bd88ec-ff84-4640-b561-243fda7270432025-08-19WarningsExact identifier
application number: M012
Daytime Nighttime Sinus Relief Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESINCVS Pharmacy1de2a7fd-129e-4b7b-a9bf-7a5811367bbf2025-08-18WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERite Aid Corporation28785677-2e80-4d6e-8997-bf5ac2ffb5a22025-08-18WarningsExact identifier
application number: M012
Daytime Mucus Relief Severe Cold and Nighttime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL,GUAIFENESINCVS Pharmacy2b7c5b5a-ebe3-4381-bb71-2359bc553df52025-08-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN6afaf85b-bf0c-4c99-acf3-a34f06be20f111
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD6afaf85b-bf0c-4c99-acf3-a34f06be20f111
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY6afaf85b-bf0c-4c99-acf3-a34f06be20f111
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY6afaf85b-bf0c-4c99-acf3-a34f06be20f111
2722413{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCKf9999875-3433-4052-a628-39539d3732162
27224131 daytime (dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG in 10 mL Oral Solution) PackPSNf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDf9999875-3433-4052-a628-39539d3732162
27224131 daytime (dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG per 10 ML Oral Solution) PackSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8762-12000318762121 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLE1 bottle2019-05-270000-00-00NoNoCurrent