FDA.reportPublic FDA data

Giltuss Diabetic

Product NDC
58552-134
11-digit product format
585520134
Labeler code
58552
Product ID
58552-134_40b857bd-5180-046f-e063-6294a90a7252
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-17
Substance
GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
200; 20 mg/10mL; mg/10mL
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

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
Giltuss Diabetic
Brand name suffix
Cough and Cold
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN200 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
85183b38-ce2a-0e0e-e053-2991aa0a336fAvailable 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-01-31Giltuss Diabetic Cough and Cold
2022-01-31Giltuss Diabetic Cough and Cold
2022-01-28Giltuss Diabetic Cough and Cold
2022-01-28Giltuss Diabetic Cough and Cold

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58552-134-04Giltuss DiabeticCough and Cold1 in 1 CARTONSOLUTION16
58552-134-04Giltuss DiabeticCough and Cold118 mL in 1 BOTTLESOLUTION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58552-134-04ML - Milliliter58552-13493286ab8-f22b-4481-9462-009f5cd85e6812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58552-134GILTUSS DIABETIC COUGH AND COLD (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [GIL PHARMACEUTICAL CORP]5Current NDC, Legacy NDC, 2 package rows20241027_85183b38-ce2a-0e0e-e053-2991aa0a336f.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 48 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NIGHTTIME CHERRY COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.36924420-f514-4225-e063-6294a90a330c2026-03-03WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS HEALTH CORP4584d701-5a4e-e54e-e063-6394a90a38d62026-03-03WarningsExact identifier
application number: M012
foster and thrive nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATESportpharm LLC7bdfd2ef-bb99-41f5-97ae-3a02c994bddd2026-03-03WarningsExact identifier
application number: M012
Medique at Home Decorel ForteACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESportpharm LLCd27b5976-8cc0-4d99-96f6-9069b786affd2026-03-03WarningsExact identifier
application number: M012
Tusnel EXGUAIFENESINA-S Medication Solutions7f703c9c-2256-4524-9d31-c51919399d262026-03-03WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)f49f1e9a-07ac-443e-9df8-3281d5f35e782026-03-03WarningsExact identifier
application number: M012
berkley and jensen nasalOXYMETAZOLINE HYDROCHLORIDEBJWC77cbe75d-4ed9-4a8b-91dc-1cc28af255082026-03-02WarningsExact identifier
application number: M012
childrens cold and cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEWalgreen Company6c7c950d-ed48-4428-9e9e-73684cabc6992026-02-28WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Kroger Co.116146db-719f-4c48-8a8a-1120ea62b0d52026-02-27Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.1f737b76-14b5-618a-e063-6294a90a19c22026-02-27WarningsExact identifier
application number: M012
WALGREENS NIGHTTIME ALLERGY RELIEFDOXYLAMINE SUCCINATEWALGREENS CO.a3c7df98-4611-4b61-9c03-5e687364bf742026-02-27WarningsExact identifier
application number: M012
MEIJER Childrens Allergy Relief ChewsDIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC3368e081-a3b2-4c03-8bd1-05cc6af0391d2026-02-27WarningsExact identifier
application number: M012
CVS PHARMACY Nighttime MS Flu ReliefACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBRCVS PHARMACY23cafaa1-34fe-4cef-960b-5f664ea32cb42026-02-27WarningsExact identifier
application number: M012
Tussin DM Cough and ChestDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC402969c9-945c-44b7-b018-b62f427ce5712026-02-26WarningsExact identifier
application number: M012
nasal originalOXYMETAZOLINE HYDROCHLORIDEHyVee Incd997f264-1b4a-4cca-a282-bd9645d55bfd2026-02-26WarningsExact identifier
application number: M012
Multi-Symptom Cold and Fever ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS PHARMACY2a569e47-3f17-4fc7-83d6-a3dddfd4987e2026-02-25WarningsExact identifier
application number: M012
Cough and Chest Congestion DN, Cough DM Daytime, NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED184059b7-9238-480e-be4a-ed105f13c19d2026-02-25WarningsExact identifier
application number: M012
Kids Daytime Cough and Nighttime Cough combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEGenexa Inc.4bad39f1-86d4-b8a1-e063-6394a90a7a952026-02-25WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLMajor Pharmaceuticals67072a38-1ae7-4e59-bfed-71db0d93215d2026-02-25WarningsExact identifier
application number: M012
leader tussin cfACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderb3e3699b-b36c-453c-8f3b-0001388c8e822026-02-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSN85183b38-ce2a-0e0e-e053-2991aa0a336f6
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD85183b38-ce2a-0e0e-e053-2991aa0a336f6
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY85183b38-ce2a-0e0e-e053-2991aa0a336f6
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY85183b38-ce2a-0e0e-e053-2991aa0a336f6
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY85183b38-ce2a-0e0e-e053-2991aa0a336f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58552-134-04585520134041 BOTTLE in 1 CARTON (58552-134-04) / 118 mL in 1 BOTTLE1 bottle2018-10-170000-00-00NoNoCurrent