FDA.reportPublic FDA data

Vicks Jarabe

Product NDC
37000-959
11-digit product format
370000959
Labeler code
37000
Product ID
37000-959_5ce12d4a-b5c4-f8cf-e063-6294a90a3bcc
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr and Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-23
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5; 100 mg/7.5mL; mg/7.5mL
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
2027-12-31
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
Vicks Jarabe
Brand name suffix
Cough Congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/7.5mL
GUAIFENESIN100 mg/7.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-959-08Vicks JarabeCough Congestion236 mL in 1 BOTTLE, PLASTICLIQUID23612

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-959VICKS JARABE COUGH CONGESTION (DEXTROMETHORPHAN HBR AND GUAIFENESIN) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 1 package rows20241012_a0fa86d4-e53b-cbf4-e053-2995a90a1396.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 58 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mixed Berry Throat and Cough LozengesBENZOCAINECVS Pharmacy737b1c88-1a44-68cf-e053-2991aa0a35b62026-01-16WarningsExact identifier
application number: M012
Walgreens Wild Cherry Throat DropsPECTINWalgreens4885eca3-c1e9-8350-e063-6394a90ac2902026-01-16WarningsExact identifier
application number: M012
HBP Chest Congestion and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensff7a1462-9994-4421-85aa-c03488bb04cf2026-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRWALGREEN COMPANYa793acbc-107c-4638-a2d7-65f4e96cafda2026-01-16WarningsExact identifier
application number: M012
MUCUS RELIEF DMGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEWalgreensca53ec26-d167-1780-e053-2a95a90a5b882026-01-16WarningsExact identifier
application number: M012
Maximum Strength Congestion and HeadacheACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens88da92d2-92c2-445a-9b70-58996e0860142026-01-16WarningsExact identifier
application number: M012
Maximum Strength Cold and FluACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens5f638bca-55c2-4ead-8c47-3f15713495da2026-01-16WarningsExact identifier
application number: M012
COLD, Flu and Sore ThroatACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEWalgreens190175bb-c08a-4050-aacf-29a130cbe05c2026-01-16WarningsExact identifier
application number: M012
Night Time Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEFSA Store Inc. (Caring Mills)a9bd1efc-51c7-40d0-a4f8-f130ce5b45ff2026-01-16WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLL.N.K. International, Inc.99147338-f459-4423-ae54-f96fffc1728d2026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC144aafcc-6ec2-a322-e063-6294a90afc272026-01-15WarningsExact identifier
application number: M012
SanaTos Severe Cold and Cough DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC14484bf5-ff45-b859-e063-6394a90a9a0f2026-01-15WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLC3429aedc-e83d-498a-bfca-03aaf5847b3b2026-01-15WarningsExact identifier
application number: M012
Quality Choice Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEChain Drug Marketing Association4b86101c-00f8-4ede-807f-db4273b37b8d2026-01-15WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Associationd1ba7267-6844-4a14-b518-65277a32e8552026-01-15WarningsExact identifier
application number: M012
ACTINEL DM PediatricDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEACTIPHARMA, LLCf85d8586-423f-48a3-9bb2-bbc5984c7cd32026-01-15WarningsExact identifier
application number: M012
ACTINEL DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINACTIPHARMA, LLC35c21623-84dd-4151-b35b-e7d30b69c9c02026-01-15WarningsExact identifier
application number: M012
Pocket FarmacyMENTHOLSaje Natural Business Inc.bdc15c6f-73b4-488e-9134-e70565df71bb2026-01-14WarningsExact identifier
application number: M012
Allergy Relief Diphenhydramine HCL 50 MGDIPHENHYDRAMINE HCLYYBA Corporation4b012549-3958-43c1-9de7-897c5d8b20d32026-01-14WarningsExact identifier
application number: M012
Rite Aid Pharmacy congestion relief vaporizing steamVAPORIZING STEAMRite Aid Pharmacy0fb86b23-0313-8fd8-e063-6394a90a0f5f2026-01-14WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014005dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral SolutionPSNa0fa86d4-e53b-cbf4-e053-2995a90a139612
1014005dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral SolutionSCDa0fa86d4-e53b-cbf4-e053-2995a90a139612
1014005dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG per 15 ML Oral SolutionSYa0fa86d4-e53b-cbf4-e053-2995a90a139612
1014005dextromethorphan hydrobromide 5 MG / guaifenesin 100 MG per 7.5 ML Oral SolutionSYa0fa86d4-e53b-cbf4-e053-2995a90a139612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-959-0837000095908236 mL in 1 BOTTLE, PLASTIC (37000-959-08) 236 ml2020-03-230000-00-00NoNoCurrent