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 63 of 231 · 4,612 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPharmacy Value Alliance, LLCd836c3e2-3b69-41f3-b166-21270550e8ab2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLPublix Super Markets, Inc.81b1d5bb-f813-4f79-9559-2494db33ad3c2026-02-05Warnings, Adverse reactionsExact identifier
application number: M012
NasalOXYMETAZOLINE HYDROCHLORIDEKroger Company6499f854-2995-48cb-9c80-be6524b3db432026-02-05WarningsExact identifier
application number: M012
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Cold and Flu plus Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.52a398eb-e593-458b-9c42-6f653ca391be2026-02-04WarningsExact identifier
application number: M012
unii: 495W7451VQ
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLHy-Vee, Inc.446de381-6685-748d-e063-6394a90a1b732026-02-04Warnings, Adverse reactionsExact identifier
application number: M012
Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED85aadc86-d979-41a1-849a-e2ccc90144292026-02-04WarningsExact identifier
application number: M012
unii: 495W7451VQ
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Incfa8c154c-56c6-47de-8e43-9e012b4be95f2026-02-04WarningsExact identifier
application number: M012
Foster and Thrive Cherry Cough DropsMENTHOLMcKesson49eefa70-cef9-d7ec-e063-6294a90ac3212026-02-03WarningsExact identifier
application number: M012
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Foster and Thrive Honey Lemon Cough DropsMENTHOLMcKesson49f13ee3-6bb3-e500-e063-6394a90a152d2026-02-03WarningsExact identifier
application number: M012
Daytime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp63cb19d4-2306-4723-a95e-9d2d8b9eccd02026-02-03WarningsExact identifier
application number: M012
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
Foster and Thrive SF Honey Lemon Cough DropsMENTHOLMcKesson49f41c30-f806-44ba-e063-6394a90a5a672026-02-03WarningsExact identifier
application number: M012
Nighttime Cold and Flu Mini SoftgelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLShield Pharmaceuticals Corpb9af8ab4-a7cb-4adf-9f6f-398c6bb7f8532026-02-03WarningsExact identifier
application number: M012
allergy reliefDIPHENHYDRAMINE HCLMeijer Distribution Inc7c2fc244-bfc5-4e3c-aa90-8bc3d067b64f2026-02-03WarningsExact identifier
application number: M012
Cold and Allergy DPSEUDOEPHEDRINE HCL, TRIPROLIDINE HCLWalgreen Company832ac849-7f4a-489a-a704-9d4388a75a712026-02-03WarningsExact identifier
application number: M012
severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc987f908b-7af7-4705-bfb4-c48d771c380d2026-02-03WarningsExact identifier
application number: M012
unii: 495W7451VQ
tussin dm nighttime maxDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Inc1f3fb451-84c9-432e-ac67-2694dd66c8152026-02-03WarningsExact identifier
application number: M012
Robafen DM CoughDEXTROMETHORPHAN HBR, GUAIFENESINMajor Pharmaceuticals7c9660b7-cb00-449b-b65f-aa42d8ce19422026-02-03WarningsExact identifier
application number: M012
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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