FDA.reportPublic FDA data

Robitussin

Product NDC
0031-2102
11-digit product format
000312102
Labeler code
0031
Product ID
0031-2102_4136d867-c2d6-01c2-e063-6394a90a428d
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin, doxylamine succinate
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-27
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
Robitussin
Brand name suffix
Childrens Honey Day Night DM Value Pack
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115329Internal RxNorm lookup
1790650Internal RxNorm lookup
2722413Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9999875-3433-4052-a628-39539d373216Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2102-01RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONKIT12
0031-8760-12RobitussinChildrens Honey Day Night DM Value Pack118 mL in 1 BOTTLESOLUTION1 mL100 mg in 10mL2
0031-8760-12RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONSOLUTION100 mg in 10mL2
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

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 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company97554f40-f9aa-4dbf-a6f2-de6197236ab42026-02-25WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLFamily Dollar Stores, Inc1b50b865-3dfc-4b3f-86d5-5e91ca7724452026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
VaproizingCAMPHORH E B577fda09-588a-4c2e-ada5-eeda32d1aabe2026-02-24Warnings, Adverse reactionsExact identifier
application number: M012
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
application number: M012
Family Wellness SF Honey Lemon Cough DropsMENTHOLFamily Dollar4437853d-1f42-a41d-e063-6294a90aa81e2026-02-24WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)64a93715-e7b1-4de1-8099-8ad6c585d5172026-02-24WarningsExact identifier
application number: M012
Cough and Chest Congestion DM DaytimeDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED86af74c2-9183-4ee9-ad1e-d88dfc8bf47d2026-02-24WarningsExact identifier
application number: M012
Cough DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED39adf23e-76f3-42e1-a9f4-55feb38078e52026-02-24WarningsExact identifier
application number: M012
Revasol Tussin DM Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINRnv LLC4b7fd320-2f39-fa1a-e063-6294a90ada9e2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and AllergyBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands47317865-4310-4f07-8815-f3130963307d2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Dimetapp Nighttime Cold and CongestionBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND DIPHENHYDRAMINE HYRDOCHLORIDEFoundation Consumer Brands42720fa0-fcdd-4614-80b2-16d0ada345b12026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brandscc09a8c5-d173-4261-b838-96e6a16e2ff92026-02-23WarningsExact identifier
application number: M012
Dimetapp Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEFoundation Consumer Brands96a1055f-e831-4f4b-8af3-7a41838c194c2026-02-23WarningsExact identifier
application number: M012
Dimetapp Cold and Cough and Nighttime Cold and CongestionDIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, BROMPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEFoundation Consumer Brands1fbe1ce0-5e3e-4af5-a5f1-85ed12ced2462026-02-23WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLBetter Living Brands, LLC0948648c-1c5f-4225-a754-120ca8859f192026-02-23Warnings, Adverse reactionsExact identifier
application number: M012
Revasol TussinGUAIFENESINRnv LLCf66dc593-9023-40e8-9cc3-0380b04b43052026-02-23WarningsExact identifier
application number: M012
Equate VaporizingCAMPHOR, EUCALYPTUS OIL, MENTHOLWal-Mart Stores Inc3006971b-784c-43fd-91a6-d96876bbf1852026-02-23WarningsExact identifier
application number: M012
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
0031-2102-01000312102011 KIT in 1 CARTON (0031-2102-01) * 1 BOTTLE in 1 CARTON (0031-8760-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLE1 kit2019-05-27NoNoCurrent
0031-8760-1200031876012118 mL in 1 BOTTLE118 mlHistorical
0031-8762-1200031876212118 mL in 1 BOTTLE118 mlHistorical