FDA.reportPublic FDA data

Robitussin Honey Maximum Strength Nighttime Cough DM

Product NDC
0031-8758
11-digit product format
000318758
Labeler code
0031
Product ID
0031-8758_176b9197-54b8-217e-e063-6394a90add78
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-25
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Maximum Strength Nighttime Cough DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0b41da13-18a1-4987-ae43-1319bfa27484Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-8758-12Robitussin Honey Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8758-12Robitussin Honey Maximum Strength Nighttime Cough DM118 mL in 1 BOTTLESOLUTION11810
0031-8758-18Robitussin Honey Maximum Strength Nighttime Cough DM1 in 1 CARTONSOLUTION110
0031-8758-18Robitussin Honey Maximum Strength Nighttime Cough DM237 mL in 1 BOTTLESOLUTION23710
0031-8758-12RobitussinHoney Cough DM Day Night Value Pack118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 20mL1
0031-8758-12RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONSOLUTION30 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8758-12ML - Milliliter0031-8758f347b7e8-eefe-40b3-a382-be63c1019bcd12019-08-06
0031-8758-18ML - Milliliter0031-87583a65a26a-eed3-49ee-9ae9-5ccf8887a83712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8758ROBITUSSIN HONEY MAXIMUM STRENGTH NIGHTTIME COUGH DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 4 package rows20240502_0b41da13-18a1-4987-ae43-1319bfa27484.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 71 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Honey Lemon cough dropsMENTHOLWalmart Stores Inc.317bbd33-6087-3af1-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Good Sense Nasal DecongestantPSEUDOEPHEDRINE HCLL. Perrigo Company455b35b4-3969-411b-8036-887615d71e112025-12-21WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLSafeway Inc.4a4f7f82-1b6c-7082-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLSafeway Inc.4a52c0c2-8659-2819-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Signature Care Cherry Cough DropsMENTHOLSafewaya733e905-af15-d3ea-e053-2a95a90aa7c32025-12-20WarningsExact identifier
application number: M012
Signature Care Honey Lemon Cough DropsMENTHOLSafewaya742449f-c76b-2b91-e053-2a95a90ae4d22025-12-20WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINETopCo60b876e7-c642-5ce8-e053-2a91aa0abd6e2025-12-20WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLTopco Associates366cc6b1-beff-29d2-e054-00144ff88e882025-12-20WarningsExact identifier
application number: M012
cherry cough dropsMENTHOLTopCo Associates3fef2117-7311-1e66-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
honey lemon cough dropsMENTHOLTopco Associates3ff1bf05-e407-3b67-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLTopco Associates36727f0c-d6d2-28a3-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLTopco Associates36824bee-607e-7095-e054-00144ff8d46c2025-12-20WarningsExact identifier
application number: M012
Mixed Berry Sore Throat LozengesBENZOCAINETopco Associates7a00c771-9231-e877-e053-2a91aa0ac96e2025-12-20WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGNUVICARE LLCe25b440e-f389-443f-b333-c66ad17471582025-12-19WarningsExact identifier
application number: M012
Cold and Flu severeACETAMINOPHEN,DEXTROMETHORPHAN HBR,GUAIFENESIN,PHENYLEPHRINE HCLWal-Mart Stores Inc9fca25dc-f63e-487a-8b7c-84d65ea51cb52025-12-19WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGeiss, Destin & Dunn Inc.a7d2eaee-484e-43aa-8ae3-0e050219383f2025-12-19WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLPublix66d8e5f7-9766-57f3-e053-2991aa0a7e172025-12-19WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLPublix66e89fa3-ee09-1d16-e053-2a91aa0ae17c2025-12-19WarningsExact identifier
application number: M012
Poly-Vent DMDEXTROMETHORPHAN HBR, GUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.739329ae-0b62-4eab-a07d-867b5d3d61e02025-12-19WarningsExact identifier
application number: M012
Chest Congestion and Cough Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINARMY AND AIR FORCE EXCHANGE SERVICE89494a7c-cdbf-48f1-aaa9-2e57d4388a682025-12-19WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN0b41da13-18a1-4987-ae43-1319bfa2748410
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD0b41da13-18a1-4987-ae43-1319bfa2748410
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY0b41da13-18a1-4987-ae43-1319bfa2748410
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY0b41da13-18a1-4987-ae43-1319bfa2748410
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) } PackGPCK1bbd0157-06e6-4a3b-bac9-91ac879ba0891
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) PackPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD1bbd0157-06e6-4a3b-bac9-91ac879ba0891
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) PackSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY1bbd0157-06e6-4a3b-bac9-91ac879ba0891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0031-8758-12000318758121 BOTTLE in 1 CARTON (0031-8758-12) / 118 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent
0031-8758-18000318758181 BOTTLE in 1 CARTON (0031-8758-18) / 237 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent