FDA.reportPublic FDA data

NDC 77333-360-25 - GUAIFENESIN 400MG CAPLETS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
77333-360
Requested NDC
77333-360-25
Package NDCs from labels
77333-360-25, 77333-360-10
Manufacturer
Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2026-01-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GUAIFENESIN - Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITEDGendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED2026-01-10HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-02GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-05-02GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)
2024-01-30GENDOSE - GUAIFENESIN 400 mg CAPLETS (77333-360)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-360-10GUAIFENESIN 400MG CAPLETS100 in 1 BOXTABLET1007
77333-360-25GUAIFENESIN 400MG CAPLETS1 in 1 BLISTER PACKTABLET17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-360GUAIFENESIN 400MG CAPLETS (GUAIFENESIN) TABLET [GENDOSE PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20240504_e7b82ec7-ef23-50c1-e053-2a95a90a662f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-360-10EA - Each77333-36059e4bbd3-6be1-4beb-b0d0-7887c885579712022-10-06
77333-360-25EA - Each77333-3603f337a09-e952-4310-a7aa-c0fc1effdaf012022-10-06

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 85 of 228 · 4,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Throat Soothing Drops Creamy StrawberryTHROAT SOOTHING CREAMY STRAWBERRYCardinal Health 110, LLC. DBA Leader26cd146a-6461-604f-e063-6394a90ac36e2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CREAMY STRAWBERRYMedical Group Care LLC043a5e11-30c3-44cd-e063-6394a90a318b2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC29f3f6dd-751e-1dfe-e063-6394a90a0dbb2025-12-22WarningsExact identifier
application number: M012
MGC Cough DropsMENTHOLMedical Group Care LLC437f6b77-ecf8-2cd8-e063-6394a90ad45d2025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEYMedical Group Care LLCf4a92a69-e562-1cec-e053-2a95a90a01652025-12-22WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS VANILLA HONEYMedical Group Care LLC043999bc-3efe-5d29-e063-6294a90a95f42025-12-22WarningsExact identifier
application number: M012
MGC Health Throat Soothing Drops Creamy StrawberryPECTINMedical Group Care LLC3fa195b5-0712-aada-e063-6394a90a90692025-12-22WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryPECTIN, MENTHOLChain Drug Marketing Association, Inc.18d28b91-55a7-4d0d-8404-4f21afdef9892025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART0668492e-c47e-b7cf-e063-6394a90a309b2025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART06574e56-13b8-a3af-e063-6394a90a48672025-12-22WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS HONEY LEMONDISCOUNT DRUG MART0668ddcc-0214-8e97-e063-6294a90a4f322025-12-22WarningsExact identifier
application number: M012
StellaLife VEGA Oral Care Peppermint Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIAStellaLife, Inc.10d42c12-713a-f461-e063-6294a90a223b2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
caring mill Cough drops CHERRYMENTHOLFSA STORE INC.9d666061-f7a8-4318-8db1-b65373689e1d2025-12-22WarningsExact identifier
application number: M012
StellaLife VEGA Oral Care Pain and Swelling ReliefARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIAStellaLife, Inc.10f8dee1-d5d3-0602-e063-6294a90a6dbf2025-12-22WarningsExact identifier
unii: ETJ7Z6XBU4
Premier ValueCOUGH DROPS CHERRYPharmacy Value Alliance LLC018f4790-8785-94f4-e063-6394a90a19162025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS HONEY LEMONPharmacy Value Alliance LLC0191fcf7-abc1-e583-e063-6294a90a78542025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS MENTHOLPharmacy Value Alliance LLC019211bf-dd4b-5f4c-e063-6294a90aacfb2025-12-22WarningsExact identifier
application number: M012
Premier ValueCOUGH DROPS BLACK CHERRY SUGAR FREEPharmacy Value Alliance LLC018f20b1-06e0-eb13-e063-6394a90a5ec52025-12-22WarningsExact identifier
application number: M012
Quality Choice Cherry Cough DropsCHERRY COUGH DROPSChain Drug Marketing Association, Inc.6a407092-4b71-4156-b4ad-930782b5fb432025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Cough DropsHONEY LEMON COUGH DROPSChain Drug Marketing Association, Inc.1fd09b04-9c79-da20-e063-6394a90ae2632025-12-22WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.