FDA.reportPublic FDA data

Robitussin

Product NDC
0031-2099
11-digit product format
000312099
Labeler code
0031
Product ID
0031-2099_413911db-b452-6adf-e063-6394a90ac22b
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin, chlorpheniramine maleate
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-12
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
Brand name suffix
Day and Night Cough Relief Value Pack
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1111440Internal RxNorm lookup
1790650Internal RxNorm lookup
2362250Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4029eccd-5443-4ae2-9232-2a1d922798f8Available 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
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
0031-2099-01RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONKIT11
0031-8692-13RobitussinDay and Night Cough Relief Value Pack118 mL in 1 BOTTLESOLUTION118 mL15 mg in 10mL1
0031-8692-13RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONSOLUTION2 mg in 10mL1
0031-8702-13RobitussinDay and Night Cough Relief Value Pack118 mL in 1 BOTTLELIQUID118 mL200 mg in 20mL1
0031-8702-13RobitussinDay and Night Cough Relief Value Pack1 in 1 CARTONLIQUID20 mg in 20mL1

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 47 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLC51e34704-5e6b-4e80-836c-ddbc24a451b22026-03-06WarningsExact identifier
application number: M012
Medi-First Plus Sinus DecongestantPHENYLEPHRINE HYDROCHLORIDESportpharm LLC20f58b0b-c123-477f-a62c-fa5423e23f932026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLSportpharm LLC7f4e8d37-8c6b-4849-b86c-4335a0bcac1c2026-03-06WarningsExact identifier
application number: M012
Daytime and Nighttime Cold and Flu KitDAYTIME AND NIGHTTIME COLD AND FLU KITAllegiant Health0533db78-7809-46ea-9998-deb5f6f1d0d92026-03-06WarningsExact identifier
application number: M012
Nasal Decongestant PEPHENYLEPHRINE HCLBetter Living Brands, LLC0153294d-7f52-4d92-8db8-daeca3e29a3b2026-03-06WarningsExact identifier
application number: M012
Mucus DMDEXTROMETHORPHAN HBR, GUAIFENESINMeijer Distribution, Inc.87cf4f25-b0e9-4f8b-bde3-0d0f26e2120e2026-03-06WarningsExact identifier
application number: M012
RYNEX PEBROMPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLEDWARDS PHARMACEUTICALS, INC.77ae1cf6-b8e5-4f3c-b7bc-e2609a8991ef2026-03-05WarningsExact identifier
application number: M012
Childrens Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLBest Choice (Valu Merchandisers Company)042f9449-4af0-4b15-bb3e-236afeb1e11f2026-03-05WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINAmerisource Bergen087a3a0b-8d3f-45ed-8807-0af47b446cac2026-03-05WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR 20MG GUAIFENESIN 400MGNUVICARE LLC6c4bc7d1-09d9-4311-8457-a1d47ab02a5a2026-03-05WarningsExact identifier
application number: M012
Allergy Relief childrensDIPHENHYDRAMINE HCLWALMART INC.dceb99a9-4aa3-4acc-b632-9a4ba8c879192026-03-04WarningsExact identifier
application number: M012
AMAZON Childrens Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEAMAZON.COM SERVICES LLC26101105-a6cf-4b51-a639-9d078542fea32026-03-04WarningsExact identifier
application number: M012
Allergy Relief ChildrensDIPHENHYDRAMINE HCLMajor Pharmaceuticals3a976e90-c6af-4414-984e-9987158c9e982026-03-04WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLBest Choice (Valu Merchandisers Company)714e93ec-0aa9-4be2-9311-399e82f148e02026-03-04WarningsExact identifier
application number: M012
Cold and Flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBest Choice (Valu Merchandisers Company)d1131759-dd2e-4c06-bb73-92dd975f55112026-03-04WarningsExact identifier
application number: M012
AMAZON Maximim Strength Adult Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAMAZON.COM SERVICES LLC6bbe8cc9-7a60-4476-b5cf-b13c5bebff262026-03-04WarningsExact identifier
application number: M012
Severe Cold and Flu Daytime, NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED5a1dfaf3-370d-4ac7-a72d-a48863a357412026-03-04WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWalgreen Companyc5cb09d4-c049-461c-8898-2c5bb6a8a1382026-03-04WarningsExact identifier
application number: M012
Tussin CFDEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCLWinCo Foods, LLC3d96d6d0-8c04-43bb-aed0-4cd00cdf34562026-03-04WarningsExact identifier
application number: M012
DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E Be2994c0f-add8-4f75-a6d2-24cd2af271e42026-03-03WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2362250{1 (chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) } PackGPCK4029eccd-5443-4ae2-9232-2a1d922798f81
23622501 daytime (dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 20 mL Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan HBr 15 MG in 10 mL Oral Solution) PackPSN4029eccd-5443-4ae2-9232-2a1d922798f81
1111440chlorpheniramine maleate 1 MG / dextromethorphan HBr 7.5 MG in 5 mL Oral SolutionPSN4029eccd-5443-4ae2-9232-2a1d922798f81
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN4029eccd-5443-4ae2-9232-2a1d922798f81
1111440chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML Oral SolutionSCD4029eccd-5443-4ae2-9232-2a1d922798f81
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD4029eccd-5443-4ae2-9232-2a1d922798f81
23622501 daytime (dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution) / 1 nighttime (chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral Solution) PackSY4029eccd-5443-4ae2-9232-2a1d922798f81
1111440chlorpheniramine maleate 1 MG / dextromethorphan hydrobromide 7.5 MG per 5 ML Oral SolutionSY4029eccd-5443-4ae2-9232-2a1d922798f81
1111440chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 10 ML Oral SolutionSY4029eccd-5443-4ae2-9232-2a1d922798f81
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY4029eccd-5443-4ae2-9232-2a1d922798f81
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY4029eccd-5443-4ae2-9232-2a1d922798f81
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY4029eccd-5443-4ae2-9232-2a1d922798f81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0031-2099-01000312099011 KIT in 1 CARTON (0031-2099-01) * 1 BOTTLE in 1 CARTON (0031-8702-13) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8692-13) / 118 mL in 1 BOTTLE1 kit2020-05-12NoNoCurrent
0031-8692-1300031869213118 mL in 1 BOTTLE118 mlHistorical
0031-8702-1300031870213118 mL in 1 BOTTLE118 mlHistorical