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#

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 86 of 228 · 4,557 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Menthol Cough DropsMENTHOL COUGH DROPSChain Drug Marketing Association, Inc.3364470e-d9bb-42a6-9bd5-80c0bed8bc9e2025-12-22WarningsExact identifier
application number: M012
Quality Choice Honey Lemon Sugar Free Cough DropsHONEY LEMON SUGAR FREE COUGH DROPSChain Drug Marketing Association, Inc.1fd0a790-c67c-216f-e063-6294a90ae9712025-12-22WarningsExact identifier
application number: M012
CAREALL DiphenhydramineDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incf3b177ef-55d5-4525-bf33-99205c414a5b2025-12-22WarningsExact identifier
application number: M012
CAREALL Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDENew World Imports, Incaf2f8389-d696-4060-8abd-6eda04e730092025-12-22WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINGRANULES USA, INC.a62d427e-f339-f225-e053-2a95a90ab3872025-12-22WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINGRANULES USA, INC.a62e2045-8ec2-1771-e053-2995a90a03b42025-12-22WarningsExact identifier
unii: 495W7451VQ
BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC82e68c65-9898-4106-a2f8-e39d124c703e2025-12-22WarningsExact identifier
application number: M012
Mucus ReliefGUAIFENESINPioneer Life Sciences, LLCbe8ec612-41a8-479e-a889-7e09f2d27c102025-12-22WarningsExact identifier
unii: 495W7451VQ
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHarris Teeter, LLC89fd57d2-fe49-41cb-b02e-9643e526cf472025-12-22WarningsExact identifier
application number: M012
Menthol Cough DropMENTHOLWalgreens464f6645-ca33-1722-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropsMENTHOLWalgreen Co.47f38e79-c730-21b9-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Cherry Cough DropMENTHOLWalgreen Co.47522852-005a-2a66-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreens Co,47653657-80b5-482f-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Honey Lemon Cough DropMENTHOLWalgreen Co.47f89d33-6e0a-4bb4-e054-00144ff88e882025-12-21WarningsExact identifier
application number: M012
Strawberry Cough DropMENTHOL 2.7 MGWalgreen Co.4766afa8-fdaf-05e5-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Menthol Cough DropMENTHOLWalgreen Co.477b9fc3-c3c5-647e-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
SF Honey Lemon Cough DropMENTHOLWalgreen Co.477cedee-6bd3-2a34-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Cherry Sore Throat LozengeBENZOCAINEWalgreens Co.47e0f809-0b30-2b23-e054-00144ff8d46c2025-12-21WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLWalgreen835e276a-493e-1038-e053-2a91aa0a7ea22025-12-21WarningsExact identifier
application number: M012
Walgreens Mixed Berry Benz-Dex LozengesBENZOCAINEWalgreene108731f-6b77-225a-e053-2a95a90ac25c2025-12-21WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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