FDA.reportPublic FDA data

Robitussin

Product NDC
0031-2102
11-digit product format
000312102
Labeler code
0031
Product ID
0031-2102_4136d867-c2d6-01c2-e063-6394a90a428d
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan HBr, guaifenesin, doxylamine succinate
Dosage form
KIT
Labeler
Haleon US Holdings LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-27
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
Childrens Honey Day Night DM 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
1115329Internal RxNorm lookup
1790650Internal RxNorm lookup
2722413Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9999875-3433-4052-a628-39539d373216Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0031-2102-01RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONKIT12
0031-8760-12RobitussinChildrens Honey Day Night DM Value Pack118 mL in 1 BOTTLESOLUTION1 mL100 mg in 10mL2
0031-8760-12RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONSOLUTION100 mg in 10mL2
0031-8762-12RobitussinChildrens Honey Day Night DM Value Pack118 mL in 1 BOTTLESOLUTION1 mL15 mg in 10mL2
0031-8762-12RobitussinChildrens Honey Day Night DM Value Pack1 in 1 CARTONSOLUTION6.25 mg in 10mL2

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 15 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense allergyDIPHENHYDRAMINE HCLL. Perrigo Companybf5039a0-2109-41a2-84a9-b5167d0a93da2026-07-22WarningsExact identifier
application number: M012
Congestion and HeadacheACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY432c3ec4-7595-4213-94e3-ce41af91804e2026-07-21WarningsExact identifier
application number: M012
SKAPEMED ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a208a1f-f6e8-0b4a-e063-6294a90a10c82026-07-21WarningsExact identifier
application number: M012
SERYNTH FAST RELIEF NASALNAPHAZOLINE HCL 0.05% FAST RELIEF NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4abdc0-aded-1b8a-e063-6394a90a9b562026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d0c03-7d8f-76cb-e063-6394a90a938c2026-07-21WarningsExact identifier
application number: M012
DERMFREE ORIGINAL NASALNAPHAZOLINE HCL 0.05%ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a4d3a2b-a4ed-c736-e063-6394a90a96df2026-07-21WarningsExact identifier
application number: M012
Severe Cough and CongestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY791eaac1-ddb5-40e2-9040-52dfadc30e062026-07-21WarningsExact identifier
application number: M012
DRx Choice DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDERaritan Pharmaceuticals Inc.9ab47b10-b1ed-4ae1-94e8-09d50e952bb02026-07-21WarningsExact identifier
application number: M012
Sleep Aid Maximum StrengthDIPHENHYDRAMINE HCLP & L Development, LLC17639c3b-5d36-41f5-bd0d-da29075abd092026-07-21WarningsExact identifier
application number: M012
NATUHEAL ORIGINAL NASALNAPHAZOLINE HCL 0.05% ORIGINAL NASALJiangxi Yudexi Pharmaceutical Co., LTD4a470b9e-c83f-fb20-e063-6294a90a2f132026-07-20WarningsExact identifier
application number: M012
TYLENOL Cold plus Flu Multi-Symptom Liquid Gels DayACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC1c444202-19e9-8d04-e063-6394a90a92942026-07-20WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART5565a581-e2b5-81a5-e063-6394a90af4092026-07-20WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)40e0b17a-5704-4203-8f0a-11b2fcf81f8f2026-07-17WarningsExact identifier
application number: M012
Equate Daytime Vapor Ice Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALMART INC.ee1ef41d-b8be-42f3-9918-ccf1c0a802412026-07-17WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.879a7804-f3d4-4a3d-bc92-b473499d6c952026-07-17WarningsExact identifier
application number: M012
Best ChoiceOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)95007785-ddf6-4386-af5f-84dac1066b402026-07-17WarningsExact identifier
application number: M012
BEST CHOICE No DripALLERGY SINUSBEST CHOICE (VALU MERCHANDISERS COMPANY)d5f95b56-8201-4d97-82ab-e23761bfe7202026-07-17WarningsExact identifier
application number: M012
Best Choice Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)7d19fdba-35b0-424a-ba11-315521d3256d2026-07-17WarningsExact identifier
application number: M012
Best Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDEBEST CHOICE (VALU MERCHANDISERS COMPANY)badb15ac-91e8-4962-96f5-beb2509775602026-07-17WarningsExact identifier
application number: M012
Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0839c07b-f692-4af1-85b8-da60fb281d492026-07-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2722413{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCKf9999875-3433-4052-a628-39539d3732162
27224131 daytime (dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG in 10 mL Oral Solution) PackPSNf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDf9999875-3433-4052-a628-39539d3732162
27224131 daytime (dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG per 10 ML Oral Solution) PackSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYf9999875-3433-4052-a628-39539d3732162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0031-2102-01000312102011 KIT in 1 CARTON (0031-2102-01) * 1 BOTTLE in 1 CARTON (0031-8760-12) / 118 mL in 1 BOTTLE * 1 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLE1 kit2019-05-27NoNoCurrent
0031-8760-1200031876012118 mL in 1 BOTTLE118 mlHistorical
0031-8762-1200031876212118 mL in 1 BOTTLE118 mlHistorical