FDA.reportPublic FDA data

NDC 70677-1005-01 - Sinus Severe

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
70677-1005
Requested NDC
70677-1005-01
Package NDCs from labels
70677-1005-1, 70677-1005-01
Manufacturer
STRATEGIC SOURCING SERVICES LLC
Effective date
2025-12-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sinus Severe - STRATEGIC SOURCING SERVICES LLCSTRATEGIC SOURCING SERVICES LLC2025-12-09HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1005-1Sinus Severe12 in 1 BLISTER PACKTABLET, COATED124
70677-1005-1Sinus Severe2 in 1 CARTONTABLET, COATED24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1005SINUS SEVERE (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20241019_30d41dc3-e2ef-4cad-b63c-d634bc749aa1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1005-1EA - Each70677-1005e3e267bd-b92d-4089-b52c-0aa5dbf8eaed12023-08-08

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 48 of 436 · 8,703 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
mucus relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRite Aid Corporation84b5d83d-aea5-42ed-b20c-96d3b389c8c02026-05-27WarningsExact identifier
unii: 495W7451VQ
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group LLC52c5fda0-c358-72e8-e063-6394a90a3f682026-05-27WarningsExact identifier
application number: M012
rxcui: 1243679
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
unii: 362O9ITL9D
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
unii: 04JA59TNSJ
Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo PackDEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC16637d54-8049-d3ce-e063-6394a90aafc92026-05-27WarningsExact identifier
application number: M012
Mucinex Maximum StrengthGUAIFENESINReckitt Benckiser LLC47f5323c-ee3a-400d-b133-31d9c286fafd2026-05-27WarningsExact identifier
unii: 495W7451VQ
Childrens Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC00689aa5-ed39-4c9a-92b8-105d2c0e2e152026-05-27WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night TimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEReckitt Benckiser LLC9aca1a68-893c-4770-8a48-d5d6780582532026-05-27WarningsExact identifier
application number: M012
Childrens Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLCd26b5143-aa07-4114-a6ba-4f503aadd46f2026-05-27WarningsExact identifier
application number: M012
unii: 495W7451VQ
MucinexGUAIFENESINReckitt Benckiser LLCdd379cdd-90ab-42e0-ad89-f50d3220f6112026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEReckitt Benckiser LLCd5f046c0-66b9-4cdc-9a1e-8e2cb5ece84f2026-05-27WarningsExact identifier
unii: 495W7451VQ
Mucinex DM Maximum StrengthGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLC588eddc1-fa30-41cc-8ed9-c01319ea21c62026-05-27WarningsExact identifier
unii: 495W7451VQ
Goodmeds Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health P.B.C.37533188-8c91-428b-a796-c5afd9e4959f2026-05-27WarningsExact identifier
application number: M012
Delsym Cough Plus Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINReckitt Benckiser LLC8252cdec-b668-4450-b045-e093479ab5422026-05-27WarningsExact identifier
application number: M012
unii: 495W7451VQ
Delsym Nighttime CoughACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDEReckitt Benckiser LLC27f9d2db-38ce-41d2-8f1a-0eb1716002742026-05-27WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Delsym Cough Plus Sore ThroatACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCb37b786e-0cce-419d-94ed-3b64a1eb12012026-05-27WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Delsym CoughDEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCa43d59f9-3a6c-4a7c-b98d-b86d6035f7162026-05-27WarningsExact identifier
application number: M012
Cold and Flu Relief Severe DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation5700ef26-ffa6-480a-bf36-bd5111799e9b2026-05-27WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
unii: 362O9ITL9D
Air PowerGUAIFENESINSchwabe North America, Inc5cdefc7a-6242-4681-88a3-04422a1d48d32026-05-27WarningsExact identifier
application number: M012
unii: 495W7451VQ

Reported adverse events (FAERS/openFDA)#

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