FDA.reportPublic FDA data

Robitussin

Product NDC
0031-2103
11-digit product format
000312103
Labeler code
0031
Product ID
0031-2103_430487ce-fbd6-66fc-e063-6294a90a32bf
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin, doxylamine succinate
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-01
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
Day and Night Maximum Strength Cough DM
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
1020138Internal RxNorm lookup
1115329Internal RxNorm lookup
2056073Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b43d8fbd-1977-4465-aa64-79e7b7f54e09Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2103-01RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONKIT11
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONSOLUTION12.5 mg in 20mL1
0031-8718-13RobitussinDay and Night Maximum Strength Cough DM118 mL in 1 BOTTLESOLUTION118 mL30 mg in 20mL1
0031-8739-12RobitussinDay and Night Maximum Strength Cough DM118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL1
0031-8739-12RobitussinDay and Night Maximum Strength Cough DM1 in 1 CARTONSOLUTION400 mg in 20mL1

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 170 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERAFLU NIGHTTIME SEVERE COLD AND COUGHACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC5f7f6f70-0f36-4541-89f2-d953259cdb1e2024-01-28WarningsExact identifier
application number: M012
RESFRIOL DACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLOPMX LLC0e9c96b9-41ac-0faf-e063-6294a90a8ab52024-01-26WarningsExact identifier
application number: M012
Allergy ReliefALLERGY RELIEFGood Sensebb709377-7bb3-4931-a2b6-2443aee07c122024-01-26WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLC721bfee2-0d3d-4d8b-beee-1ea83064d1c82024-01-23WarningsExact identifier
application number: M012
Sugar Free Cough Drops Honey LemonMENTHOLCardinal Health 110, Inc.fe90dc33-2815-8296-e053-6294a90ac1df2024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLCardinal Health 110, Inc.fe91543e-a798-6399-e053-6394a90af5e52024-01-19WarningsExact identifier
application number: M012
Sugar Free Cough Drops Black CherryMENTHOLCardinal Health 110, Inc.fe90cf63-d286-fa5e-e053-6394a90a77592024-01-19WarningsExact identifier
application number: M012
Cough Drops Menthol Honey LemonCOUGH DROPS MENTHOLCardinal Health 110, Inc.fe5b3f6d-2a2d-f322-e053-6394a90aba042024-01-19WarningsExact identifier
application number: M012
Cough Drops MentholMENTHOL COUGH DROPSCardinal Health 110, Inc.fe5b557e-a689-a32c-e053-6294a90aadbd2024-01-19WarningsExact identifier
application number: M012
Cough Drops CherryCHERRY FLAVOR COUGH DROPSCardinal Health 110, Inc.fe5b5e57-1368-c62b-e053-6294a90ae82c2024-01-19WarningsExact identifier
application number: M012
Leader Zinc OxideZINC OXIDECardinal Health 110,Inc.4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d12024-01-18WarningsExact identifier
application number: M012
Cough and Congestion DM Sugar FreeDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBest Choice (Valu Merchandisers Company)4656e60e-4733-45c1-bf55-d156e45085c62024-01-17WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLRugby Laboratories775f97c0-6f82-49a8-82ac-f1a73920c3ec2024-01-11WarningsExact identifier
application number: M012
SinuFrin NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Incf9ec6ac3-1e00-4e97-97c8-b2cd66a752ae2024-01-11WarningsExact identifier
application number: M012
SinuFrin Plus NeilMedOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals, Inc.99afe6a6-1350-49c6-9347-b7e531e359252024-01-11WarningsExact identifier
application number: M012
Childrens Tukol Multi-Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.85fe6f0f-41c8-44d3-a34a-355938da5f722024-01-11WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HClDIPHENHYDRAMINE HYDROCHLORIDECardinal Health 110, LLC. DBA Leaderad437177-08eb-4811-883f-ac543d5bc58c2024-01-11WarningsExact identifier
application number: M012
Allergy AntihistamineDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYaf5053d8-ba02-4cdf-877f-8c1e368dafe02024-01-10WarningsExact identifier
application number: M012
HISTEXTRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLCcc466d33-cf3e-4f1c-a794-6d3d79903adf2024-01-08WarningsExact identifier
application number: M012
HISTEX-DMDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDEAllegis Pharmaceuticals, LLC836d062c-29f0-4fd7-b65c-771a3bbd52c42024-01-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056073{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCKb43d8fbd-1977-4465-aa64-79e7b7f54e091
20560731 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) PackPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDb43d8fbd-1977-4465-aa64-79e7b7f54e091
20560731 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) PackSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYb43d8fbd-1977-4465-aa64-79e7b7f54e091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0031-2103-01000312103011 KIT in 1 CARTON (0031-2103-01) * 1 BOTTLE in 1 CARTON (0031-8739-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8718-13) / 118 mL in 1 BOTTLE1 kit2021-03-01NoNoCurrent
0031-8718-13000318718131 in 1 CARTONHistorical
0031-8739-1200031873912118 mL in 1 BOTTLE118 mlHistorical