FDA.reportPublic FDA data

Robitussin Honey Severe Cough, Flu Plus Sore Throat

Product NDC
0031-8771
11-digit product format
000318771
Labeler code
0031
Product ID
0031-8771_35087921-feaf-18e1-e063-6294a90a1471
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hbr
Dosage form
SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
650; 20 mg/20mL; mg/20mL
Pharmacologic classes
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

Additional Listing Data#

Finished product
Yes
Brand name base
Robitussin Honey Severe Cough, Flu Plus Sore Throat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH
Rxcui1919076

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
0031-8771-12Robitussin Honey Severe Cough, Flu Plus Sore Throat118 mL in 1 BOTTLESOLUTION1188
0031-8771-12Robitussin Honey Severe Cough, Flu Plus Sore Throat1 in 1 CARTONSOLUTION18
0031-8771-18Robitussin Honey Severe Cough, Flu Plus Sore Throat1 in 1 CARTONSOLUTION18
0031-8771-18Robitussin Honey Severe Cough, Flu Plus Sore Throat237 mL in 1 BOTTLESOLUTION2378

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8771-12ML - Milliliter0031-87716abfaab9-c6ac-46e9-a043-f57ebd1f93aa12023-05-05
0031-8771-18ML - Milliliter0031-877183b83368-9e58-4404-b451-6c0f75c1aa0612023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8771ROBITUSSIN HONEY SEVERE COUGH, FLU PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SOLUTION [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20250515_77be57fb-0ae5-4fad-97f3-b6a4b57383a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral SolutionPSN77be57fb-0ae5-4fad-97f3-b6a4b57383a98
1919076acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD77be57fb-0ae5-4fad-97f3-b6a4b57383a98
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral SolutionSY77be57fb-0ae5-4fad-97f3-b6a4b57383a98
1919076acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral SolutionSY77be57fb-0ae5-4fad-97f3-b6a4b57383a98
1919076APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY77be57fb-0ae5-4fad-97f3-b6a4b57383a98

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8771-12000318771121 BOTTLE in 1 CARTON (0031-8771-12) / 118 mL in 1 BOTTLE1 bottle2020-06-150000-00-00NoNoCurrent
0031-8771-18000318771181 BOTTLE in 1 CARTON (0031-8771-18) / 237 mL in 1 BOTTLE1 bottle2020-06-150000-00-00NoNoCurrent