FDA.reportPublic FDA data

NDC 70677-1258-01 - Guaifenesin 600 mg

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
70677-1258
Requested NDC
70677-1258-01
Package NDCs from labels
70677-1258-1, 70677-1258-01
Manufacturer
Strategic Sourcing Services, LLC
Effective date
2024-11-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guaifenesin 600 mg - Strategic Sourcing Services, LLCStrategic Sourcing Services, LLC2024-11-09HUMAN OTC DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1258GUAIFENESIN 600 MG (GUAIFENESIN ) TABLET, EXTENDED RELEASE GUAIFENESIN 1200 MG (GUAIFENESIN) TABLET, EXTENDED RELEASE [STRATEGIC SOURCING SERVICES, LLC ]1Current NDC20241112_469c5f00-1b6c-6fc7-a352-65764ff25d45.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1258-1EA - Each70677-12583206e628-118b-4567-ab77-8258a681b56d12025-05-14

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 9 of 98 · 1,945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Guaicon InsydoseGUAIFENESINUnifirst First Aid Corporation5b230d04-3cf2-51e0-e063-6294a90a24982026-07-01WarningsExact identifier
unii: 495W7451VQ
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
unii: 495W7451VQ
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
MucinexGUAIFENESINBryant Ranch Prepacka898b584-e17e-45c4-8a28-9f686b95dca02026-06-29WarningsExact identifier
rxcui: 636522
unii: 495W7451VQ
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
unii: 495W7451VQ
MucinexGUAIFENESINBryant Ranch Prepacka8c67e0a-1f2c-4e96-91fe-0d90546d8b1b2026-06-29WarningsExact identifier
rxcui: 636522
unii: 495W7451VQ
MUCUS RELIEF DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdb57f6b3-30ca-4a65-9043-f61be24d9b502026-06-25WarningsExact identifier
unii: 495W7451VQ
GuaifenesinGUAIFENESINYYBA CORP4cb11551-31e3-5c01-e063-6394a90ab0d42026-06-25WarningsExact identifier
rxcui: 636522
unii: 495W7451VQ
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
unii: 495W7451VQ
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
MUCUS RELIEF - DM MAXIMUM STRENGTHGUAIFENESIN, DEXTROMETHORPHAN HBRYYBA CORP4f6da14e-f2ca-cb33-e063-6394a90a9ff82026-06-24WarningsExact identifier
unii: 495W7451VQ
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
unii: 495W7451VQ
MUCUS RELIEFGUAIFENESINYYBA Corp5074b172-311b-43e2-e063-6394a90aa70f2026-06-22WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
Topcare Mucus ERGUAIFENESINTopco Associates LLC916de841-b1eb-4f00-9e25-1d2e4ab0c6e92026-06-18WarningsExact identifier
rxcui: 310621
unii: 495W7451VQ
GUAIFENESINGUAIFENESINCardinal Health 107, LLC888b6a2e-6631-4585-a7fe-eb122eb51b232026-06-18WarningsExact identifier
unii: 495W7451VQ
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC1a21cbb2-1ba5-414f-a31f-42b7a7bddae52026-06-16WarningsExact identifier
unii: 495W7451VQ
Tussin DM RegularDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.5460c809-71c8-3ad6-e063-6294a90a4e4f2026-06-16WarningsExact identifier
unii: 495W7451VQ
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
severe sinus congestion relief Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation51175d3e-e1c3-4e4d-ad32-61600e87568c2026-06-16WarningsExact identifier
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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