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

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 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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1919076Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77be57fb-0ae5-4fad-97f3-b6a4b57383a9Available on FDA.report

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

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 124 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SDA Laboratories TussinGUAIFENESINSDA Laboratories, Inc.2a444cc8-96be-9432-e063-6394a90a1b632024-12-27WarningsExact identifier
application number: M012
SDA Laboratories Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINSDA Laboratories, Inc.2a445f31-818d-11b1-e063-6294a90a8cb12024-12-27WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.2792032a-ff0f-4d5f-a8e3-b8b8c54f4e992024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.c7b1f980-9b0d-4f63-a70d-fd366658f8632024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.2ee2b332-9b85-45a6-b242-3f0ebfbd08a62024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012

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