FDA.reportPublic FDA data

rugby cough syrup

Product NDC
0536-1348
11-digit product format
005361348
Labeler code
0536
Product ID
0536-1348_d9370b6a-e781-444d-87c9-f9acb5bcfee5
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Rugby Laboratories
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-07
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 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
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
rugby cough syrup
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 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
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89752c69-25c8-45e3-9021-f81b35b52d36Available 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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1348-97rugby cough syrup1 in 1 CARTONSOLUTION12
0536-1348-97rugby cough syrup118 mL in 1 BOTTLESOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1348-97ML - Milliliter0536-13488e88d1cc-c1e0-41da-a3f9-c8a51f3257e112022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1348RUGBY COUGH SYRUP (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [RUGBY LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20241109_89752c69-25c8-45e3-9021-f81b35b52d36.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 56 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu Daytime, Nighttime, Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreens9862f84d-1c18-4ef7-86dc-98572599d4172026-01-19WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreens37853689-c9ca-4bc7-9c5b-4a68b8d778be2026-01-19WarningsExact identifier
application number: M012
VAPORXCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLAKRON PHARMA INC51b32162-0c5a-4b5b-999a-34337d8166032026-01-19WarningsExact identifier
application number: M012
EquateOXYMETAZOLINE HCLWalmart Inc2f762c24-2442-506a-e063-6394a90a3b962026-01-19WarningsExact identifier
application number: M012
DimetaneDIPHENHYDRAMINE HYDROCHLORIDERising Pharma Holdings, Inc.484d6a37-b84e-4ead-bb89-9c3d8c3bcd2f2026-01-19WarningsExact identifier
application number: M012
nitetimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPublix Super Markets Incf681d986-9838-42d8-8ed9-732a39fbf8702026-01-19WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLH E B22d241c5-a3fd-4619-8147-91d7a4c8cf982026-01-19WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLBetter Living Brands, LLC9fe63ca6-3863-4175-9aec-ecd6ebbdb2492026-01-19WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerisource Bergen5749ce9d-e182-478f-ab88-b520a35a99a72026-01-19WarningsExact identifier
application number: M012
Foster and Thrive Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC1d9150b1-2f6c-4c33-8c93-3ed1d88585e22026-01-18WarningsExact identifier
application number: M012
HealthWise Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLVeridian Healthcarece3ceffd-3ff5-3795-e053-2995a90a827f2026-01-18WarningsExact identifier
application number: M012
topcare nite time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETopco Associates LLC31210a95-f9dc-49db-aab5-25c4dca492662026-01-17WarningsExact identifier
application number: M012
Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf77226c0-b6d5-9fd0-e053-6294a90a4b572026-01-16WarningsExact identifier
application number: M012
Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf691734b-5cf4-6eb8-e053-2a95a90aee802026-01-16WarningsExact identifier
application number: M012
Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus CongestionACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLProcter & Gamble Manufactura S de RL de CVf771aa19-295a-9f4e-e053-6294a90a16742026-01-16WarningsExact identifier
application number: M012
CVS Cherry Cough DropsMENTHOLCVS Pharmacyde5c4b94-0420-5d43-e053-2995a90aa5a52026-01-16WarningsExact identifier
application number: M012
CVS Honey Lemon Cough DropsMENTHOLCVS Pharmacyde963dc3-8108-440f-e053-2995a90a906f2026-01-16WarningsExact identifier
application number: M012
CVS SF Menthol Cough DropsMENTHOLCVS Pharmacye08f8ca3-b683-4964-e053-2a95a90afabb2026-01-16WarningsExact identifier
application number: M012
CVS SF Honey Lemon Cough DropsMENTHOLCVS Pharmacye0cdeccf-c32f-318a-e053-2a95a90ac4012026-01-16WarningsExact identifier
application number: M012
Mixed Berry Throat and Cough LozengesBENZOCAINECVS Pharmacy737b1c88-1a44-68cf-e053-2991aa0a35b62026-01-16WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYc0f389ec-a683-4555-8892-896b3165952a5
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSN89752c69-25c8-45e3-9021-f81b35b52d362
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD89752c69-25c8-45e3-9021-f81b35b52d362
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY89752c69-25c8-45e3-9021-f81b35b52d362
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY89752c69-25c8-45e3-9021-f81b35b52d362
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY89752c69-25c8-45e3-9021-f81b35b52d362
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNebf2a96b-0e5f-3f9b-e053-2995a90a13601
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDebf2a96b-0e5f-3f9b-e053-2995a90a13601
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYebf2a96b-0e5f-3f9b-e053-2995a90a13601
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYebf2a96b-0e5f-3f9b-e053-2995a90a13601
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYebf2a96b-0e5f-3f9b-e053-2995a90a13601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1348-97005361348971 BOTTLE in 1 CARTON (0536-1348-97) / 118 mL in 1 BOTTLE1 bottle2022-01-070000-00-00NoNoCurrent