FDA.reportPublic FDA data

Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime

Product NDC
0031-0101
11-digit product format
000310101
Labeler code
0031
Product ID
0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hcl
Dosage form
LIQUID
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-15
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
650; 25 mg/20mL; mg/20mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2374554Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
721bfee2-0d3d-4d8b-beee-1ea83064d1c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-0101-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime1 in 1 CARTONLIQUID11
0031-0101-04Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime118 mL in 1 BOTTLELIQUID1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-0101ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240215_721bfee2-0d3d-4d8b-beee-1ea83064d1c8.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 24 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra Allergy 24 hourFEXOFENADINE HYDROCHLORIDESelect Consumer Group2de81a41-8488-7e39-e063-6294a90a394b2026-06-01WarningsExact identifier
application number: M012
Cough and Runny Nose Childrens PlusACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDETOP CARE (Topco Associates LLC)6f04bd51-093c-4624-aef3-0145ac3873862026-06-01WarningsExact identifier
application number: M012
NasalPHENYLEPHRINE HYDROCHLORIDECVS Pharmacy694a3116-1b75-42cd-bbcf-d19831c2d7962026-06-01WarningsExact identifier
application number: M012
night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEH E Bcf31538c-9eee-4c81-80cb-66eecabf0aff2026-06-01WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC155e07b3-0a08-3be8-e063-6394a90a76352026-05-31WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough NighttimeDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC156033ae-b16a-007b-e063-6294a90a74452026-05-31WarningsExact identifier
application number: M012
Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyebf8c82d-a653-4c02-893b-61704901acbb2026-05-29WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLAmerisource Bergen934c7b91-3cba-47f0-8efa-77216f3f15c42026-05-29WarningsExact identifier
application number: M012
Allergy MedicineDIPHENHYDRAMINE HCLCOSTCO WHOLESALE CORPORATIONd9f03e11-d11f-43ee-8ed0-9e07d1058f662026-05-29WarningsExact identifier
application number: M012
Cold Childrens, Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACYeaa07dd4-cb7e-45ca-abe4-7a3f7a9d928d2026-05-29WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC3598ac5b-29f9-f002-e063-6294a90a62cb2026-05-28WarningsExact identifier
application number: M012
NebuClear MDRACEPINEPHRINE HYDROCHLORIDEBlue Echo Care LLC51badd2f-4a43-3dbe-e063-6294a90a4bd12026-05-28WarningsExact identifier
application number: M012
Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.a7ab2140-de09-158f-e053-2a95a90a25a02026-05-28WarningsExact identifier
application number: M012
Kids Multi Symptom Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.2d918ec8-3098-1d09-e063-6294a90a9e8f2026-05-28WarningsExact identifier
application number: M012
Daytime and Nighttime Kids Multi-Symptom Cold and Flu combo packACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCLGenexa Inc.213fe898-dace-9a0f-e063-6394a90afd642026-05-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey Lemon FlavorMENTHOLMedical Group Care LLC556628ab-e233-92fe-e063-6394a90a00902026-05-28WarningsExact identifier
application number: M012
Sinus Decongestion PEPHENYLEPHRINE HCLKroger Company68eff734-177e-4999-9126-6b92bb2041072026-05-28WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRARMY AND AIR FORCE EXCHANGE SERVICEff39084f-ab2f-48ed-ac62-837f7fff2b652026-05-28WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2374554acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 20 mL Oral SolutionPSN721bfee2-0d3d-4d8b-beee-1ea83064d1c81
2374554acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSCD721bfee2-0d3d-4d8b-beee-1ea83064d1c81
2374554acetaminophen 650 MG / diphenhydramine HCl 25 MG per 20 mL Oral SolutionSY721bfee2-0d3d-4d8b-beee-1ea83064d1c81
2374554APAP 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML Oral SolutionSY721bfee2-0d3d-4d8b-beee-1ea83064d1c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0031-0101-04000310101041 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLE1 bottle2024-02-15NoNoCurrent