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 125 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC.2ee2b332-9b85-45a6-b242-3f0ebfbd08a62024-12-26WarningsExact identifier
application number: M012
OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INCaebc7cf8-aaf7-4746-89f5-a64d0be1641e2024-12-26WarningsExact identifier
application number: M012
Foster and Thrive Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa1661a66-5e8c-4144-9c82-cbbcc75fb2222024-12-23WarningsExact identifier
application number: M012
Geri DrylDIPHENHYDRAMINE HCLGERI-CARE PHARMACEUTICALS, CORP34d36146-6827-4800-8483-c0edb8f4cc282024-12-23WarningsExact identifier
application number: M012
Guaiasorb DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp6299e352-116e-43f2-b40f-c704a7bd5d612024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion ReliefGUAIFENESINUnited Natural Foods, Inc. dba UNFIad9fde8b-10cd-4778-917d-1ed6b67e5ab12024-12-23WarningsExact identifier
application number: M012
Equaline Chest Congestion Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINUnited Natural Foods, Inc. dba UNFIa40f5893-eb96-4e0e-b965-d78293c48dc92024-12-23WarningsExact identifier
application number: M012
Tukol X-Pecto Miel Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.b9d32964-5bd7-44b0-be98-827d5310ed4f2024-12-20WarningsExact identifier
application number: M012
Halls Honey VanillaMENTHOLMondelez Global LLC8e94a1b8-8915-4595-b097-8a0a319d54aa2024-12-20WarningsExact identifier
application number: M012
Halls Sugar Free Mentho-LyptusMENTHOLMondelez Global LLC96046858-c57b-426e-8279-91b35e05bcdb2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, Best ChoiceLEVMETAMFETAMINEValu Merchandisers Company3f1c086c-bc22-4abb-9921-565a13f30c202024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTWalgreens77924474-ccc7-497b-9168-91490bcfadfc2024-12-20WarningsExact identifier
application number: M012
LevmetamfetamineLEVMETAMFETAMINEMeijer, Inc.d11e916f-90a6-4099-bf83-75f2dfbd62662024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, DG healthLEVMETAMFETAMINEDolgencorp Inc.5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd32024-12-20WarningsExact identifier
application number: M012
Tukol Multi Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGenomma Lab USA, Inc.aef2ad43-145d-4abc-bccc-2c5fdd6882f92024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, TopCare healthLEVMETAMFETAMINETopco Associates LLC8f995561-759a-4837-a82a-640417a6f8892024-12-20WarningsExact identifier
application number: M012
Childrens CoughDEXTROMETHORPHAN HBR, GUAIFENESINWal-Mart Stores, Inc.50a0eaa5-fa73-4d84-86fc-3546c85cf3532024-12-20WarningsExact identifier
application number: M012
Equate Childrens Multi symptom Cold NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWal-Mart Stores, Inc.bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee2024-12-20WarningsExact identifier
application number: M012
Vapor InhalerLEVMETAMFETAMINE NASAL DECONGESTANTC.D.M.A., Inc.904b7e21-cce5-4b96-afc1-b36f532f98ac2024-12-20WarningsExact identifier
application number: M012
Vapor Inhaler levmetamfetamine nasal decongestant, EqualineLEVMETAMFETAMINESupervalu Inc.44f72f34-d0b8-421f-b240-86286de874cf2024-12-20WarningsExact 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