FDA.reportPublic FDA data

Robitussin Honey Maximum Strength Cough and Chest Congestion DM

Product NDC
0031-8756
11-digit product format
000318756
Labeler code
0031
Product ID
0031-8756_178d098c-514f-d1fe-e063-6294a90af6ca
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin
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; GUAIFENESIN
Active strength
20; 400 mg/20mL; mg/20mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Maximum Strength Cough and Chest Congestion DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 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
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaa10aed-5b1e-48bf-bc05-7a5638851dafAvailable 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
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM118 mL in 1 BOTTLESOLUTION1188
0031-8756-12Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM1 in 1 CARTONSOLUTION18
0031-8756-18Robitussin Honey Maximum Strength Cough and Chest Congestion DM237 mL in 1 BOTTLESOLUTION2378
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack1 in 1 CARTONSOLUTION400 mg in 20mL1
0031-8756-12RobitussinHoney Cough DM Day Night Value Pack118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0031-8756-12ML - Milliliter0031-87568416ba12-afa1-4752-97ab-31d20f644e5f12019-07-02
0031-8756-18ML - Milliliter0031-8756913071af-382f-4fe6-ad2d-df68bbb113a912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0031-8756ROBITUSSIN HONEY MAXIMUM STRENGTH COUGH AND CHEST CONGESTION DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20240504_eaa10aed-5b1e-48bf-bc05-7a5638851daf.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 1 of 194 · 3,880 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLFamily Dollar Services Incce590997-3cae-4f22-ac39-2b14d39494bc2026-07-30WarningsExact identifier
application number: M012
Robitussin Direct CoughDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC70c9556b-063a-4fb3-96f6-1d4ffa495ed42026-07-30WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.a302e341-1c00-4c3d-b71f-c4c0b307aa672026-07-29WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreens4c737cd6-fe56-4cef-887c-cd6cf83b254c2026-07-29WarningsExact identifier
application number: M012
ROBITUSSIN LONG-ACTING COUGHGELSDEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC472c5c1f-eb5a-444b-a17e-f0d71007fb152026-07-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLU NITETIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEMeijer Distribution Inc3a33c6ce-aada-4099-8c61-49c86c0fc1a82026-07-29WarningsExact identifier
application number: M012
Tussin DM Max NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWal-Mart Stores Inc668c92ce-6c1f-4ab3-b0dd-822b0768cb5e2026-07-29WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC702f9786-7ce9-43e4-921d-e1db096121272026-07-28WarningsExact identifier
application number: M012
LoHist-DCHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCLLarken Laboratories, Inc.efaa354e-c25c-405b-9d30-001c2796978c2026-07-28WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd1115a55-35cd-4f20-8872-f42983a5ebcd2026-07-28WarningsExact identifier
application number: M012
TUSSINDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSafewaya5e2bda4-2da6-4c20-855d-2888dadf0c3a2026-07-28WarningsExact identifier
application number: M012
DM MaximumDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf6029b04-e681-40fc-be4f-14091b76dd4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLCVS PHARMACYe958eef1-8aae-4365-ac64-95a9e8e7e0f22026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP INC38400854-27fa-e291-e063-6294a90a5c4e2026-07-27WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBetter Living Brands, LLC65802aa7-64e7-4435-ad6b-65895fba17ce2026-07-27WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLWalgreen Company0a48f650-ad2a-4105-9ff4-2bc4d94b46d32026-07-27WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreen Company84202ebe-97b6-4be2-bb09-7f2729303f962026-07-27WarningsExact identifier
application number: M012
Daytime Severe Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation8d41defe-8120-4cbb-b42e-c805cc5a794b2026-07-24WarningsExact identifier
application number: M012
Childrens Benadryl ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCfc9181b9-c92d-493e-8d7c-4a4239c6c0922026-07-24WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.3afc88c7-388a-dbd9-e063-6294a90a4faf2026-07-24WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYeaa10aed-5b1e-48bf-bc05-7a5638851daf8
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYeaa10aed-5b1e-48bf-bc05-7a5638851daf8
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
0031-8756-12000318756121 BOTTLE in 1 CARTON (0031-8756-12) / 118 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent
0031-8756-18000318756181 BOTTLE in 1 CARTON (0031-8756-18) / 237 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent