FDA.reportPublic FDA data

Giltuss EX Maximum Strength Expectorant

Product NDC
58552-341
11-digit product format
585520341
Labeler code
58552
Product ID
58552-341_51b2b733-3d3b-762d-e063-6294a90a41a5
Type
HUMAN OTC DRUG
Nonproprietary name
Giltuss EX Maximum Strength Expectorant
Dosage form
TABLET
Route
ORAL
Labeler
Gil Pharmaceutical Corp
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-07
Substance
GUAIFENESIN
Active strength
1200 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
Giltuss EX Maximum Strength Expectorant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN1200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310621Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
950db1ca-6936-47f8-a112-e3594d4c922cAvailable on FDA.report

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
58552-341-07Giltuss EX Maximum Strength Expectorant1 in 1 CARTONTABLET12
58552-341-07Giltuss EX Maximum Strength Expectorant7 in 1 BLISTER PACKTABLET72
58552-341-14Giltuss EX Maximum Strength Expectorant1 in 1 CARTONTABLET12
58552-341-14Giltuss EX Maximum Strength Expectorant14 in 1 BOTTLETABLET142

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 119 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestantOXYMETAZOLINE HYDROCHLORIDESafewayf1d0edd5-fe58-4de0-98f4-07fb24bd0ac22025-02-19WarningsExact identifier
application number: M012
Coricidin HBP Cold and FluACETAMINOPHEN AND CHLORPHENIRAMINE MALEATEBayer HealthCare LLC.763a5334-a741-4678-9947-6037766224502025-02-18WarningsExact identifier
application number: M012
Sof Skin Vaporizing Chest Rub and Cough SuppressantMENTHOL AND CAMPHOR AND EUCALYPTUS OILViny Health and Beauty Inc46ae16a4-b8a7-44de-ae1a-9bb503c15ea02025-02-18WarningsExact identifier
application number: M012
Pain Reliever PMACETAMINOPHEN DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)4897d1df-4fb3-46e2-bbf0-847e964dca0a2025-02-18WarningsExact identifier
application number: M012
meijer EXTRA STRENGTH Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bee7e4f-1813-1bdf-e063-6294a90a6a322025-02-17WarningsExact identifier
application number: M012
ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAILFENESIN,PHENLYEPHRINE HCLACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAILFENESIN,PHENLYEPHRINE HCLKroger Companya24f09d9-60f1-853a-e053-2a95a90ae1fa2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN,DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLFAMILY DOLLAR SERVICESa7343bea-53cc-4621-e053-2a95a90a2a5f2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAY-NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8f6dd0-d19f-0c10-e053-2a95a90a1e8a2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENGHT DAY COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE HCLFAMILY DOLLARaa8ebccf-6813-2dca-e053-2a95a90a032b2025-02-15WarningsExact identifier
application number: M012
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULAACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLFAMILY DOLLARaa8f0465-1595-0b0f-e053-2a95a90a00812025-02-15WarningsExact identifier
application number: M012
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINKROGER COMPANY9bb7aaf0-6698-9a5c-e053-2a95a90a097c2025-02-14WarningsExact identifier
application number: M012
DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH-E-Bdb432947-fe02-79b2-e053-2a95a90af4a92025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free CherryMENTHOLMondelez Global LLCea8dfe96-f6a4-4172-bf9e-ae3cf606ff502025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
application number: M012
Tukol Max ActionOXYMETAZOLINE HYDROCHLORIDEGenomma Lab USA73358103-43dc-4b11-9c89-9a6ba45bf1af2025-02-14WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.6c4e867b-24b9-4525-9fab-10f1e7910b132025-02-13WarningsExact identifier
application number: M012
DAYTIME- NIGHTTIME COLD AND FLUDAYTIME NIGHTTIME COLD AND FLUTARGET CORP9def204a-ee1e-6868-e053-2995a90a76b82025-02-13WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nigttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c11b63-278f-64de-e053-2995a90a5aae2025-02-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBETTER LIVING BRANDS LLC.f29c604a-271d-a702-e053-2a95a90a34272025-02-12WarningsExact identifier
application number: M012
Nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c01090-645c-1efe-e053-2995a90a7df52025-02-12WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310621guaiFENesin 1200 MG 12HR Extended Release Oral TabletPSN950db1ca-6936-47f8-a112-e3594d4c922c2
31062112 HR guaifenesin 1200 MG Extended Release Oral TabletSCD950db1ca-6936-47f8-a112-e3594d4c922c2
310621guaifenesin 1200 MG 12 HR Extended Release Oral TabletSY950db1ca-6936-47f8-a112-e3594d4c922c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58552-341-07585520341071 BLISTER PACK in 1 CARTON (58552-341-07) / 7 TABLET in 1 BLISTER PACK1 blister pack2025-10-07YesNoCurrent
58552-341-14585520341141 BOTTLE in 1 CARTON (58552-341-14) / 14 TABLET in 1 BOTTLE1 bottle2025-10-07NoNoCurrent