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 76 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB SF Honey Lemon Cough DropsMENTHOLHEBd09ed4bb-7595-5e54-e053-2a95a90aa1092025-12-13WarningsExact identifier
application number: M012
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382025-12-13WarningsExact identifier
application number: M012
HEB Honey Lemon Cough DropsMENTHOLHEBc19a79bc-9872-2e87-e053-2a95a90a94272025-12-13WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.26f55169-4b37-4a36-88ee-064d6e9620652025-12-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalgreen Company39ce76a3-b7a8-43be-9b61-5c1446cd9e902025-12-12WarningsExact identifier
application number: M012
Cold and Flu maximum strengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporationac01206f-a717-4c0b-8a03-fab0a4fd154b2025-12-12WarningsExact identifier
application number: M012
Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLStrategic Sourcing Services LLCdcb80dd5-465d-4792-947a-3044e25a52842025-12-12WarningsExact identifier
application number: M012
Vapor RubCOUGH SUPPRESSANTNeilmed Pharmaceuticals Inc.39190f9f-8a5a-e4d8-e063-6294a90a57dd2025-12-12WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLCardinal Health, 110 dba LEADERb7393668-1450-4e85-9793-d400daf39b432025-12-12WarningsExact identifier
application number: M012
Allergy Relief, 24-7 Life by 7-ElevenDIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c4cd6c-327d-5950-e063-6394a90a3a212025-12-12WarningsExact identifier
application number: M012
Menthol cough dropsMENTHOLFamily Dollar44bb3b95-b2ba-470e-e054-00144ff88e882025-12-12WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLFamily Dollar44bb9c7b-994b-4ab8-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44be9837-f15a-09f2-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLFamily Dollar44bcae39-2389-09ee-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar46635813-66c4-504c-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLFamily Dollar455b0f4b-0526-2361-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M012
Family Wellness Strawberry Cough DropsMENTHOLFamily Dollarf92466ac-dd93-9ac5-e053-6294a90a92912025-12-12WarningsExact identifier
application number: M012
GoodSense Menthol Cough DropsMENTHOLGeiss, Destin, Dunnc6b25d69-8930-6867-e053-2a95a90ad2082025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Cough DropsMENTHOLGeiss, Destin, Dunnc72db7f0-9324-8ed2-e053-2995a90a98682025-12-12WarningsExact identifier
application number: M012
Good Sense Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunnc72e557f-0211-81b9-e053-2995a90a14372025-12-12WarningsExact 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