FDA.reportPublic FDA data

NDC 83059-0044-01 - Allergy plus Sinus Headache

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
83059-0044
Requested NDC
83059-0044-01
Package NDCs from labels
83059-0044-1, 83059-0044-01
Manufacturer
Shield Pharmaceuticals Corp
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Allergy plus Sinus Headache - Shield Pharmaceuticals CorpShield Pharmaceuticals Corp2026-07-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0044-1Allergy plus Sinus Headache15 in 1 BOTTLETABLET, FILM COATED154
83059-0044-1Allergy plus Sinus Headache1 in 1 PACKAGETABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83059-0044ALLERGY PLUS SINUS HEADACHE (ACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MG) TABLET, FILM COATED [SHIELD PHARMACEUTICALS CORP]3Current NDC, 2 package rows20241228_772d0184-8c41-40f1-bbef-7e68692eec66.zip

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 82 of 438 · 8,744 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3e73a5f7-5976-4839-9705-c1730ff6bf302026-03-25WarningsExact identifier
application number: M012
unii: TC2D6JAD40
GOOD SENSE TUSSINACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINL. Perrigo Company5fb96638-a9bc-4be6-a624-da303a9e98a32026-03-25WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Cold and Flu Relief Multi symptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWinCo Foods, LLC9beeeb3b-6b26-4b9a-843b-ce3658d1debe2026-03-25WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack1d63d261-bdd4-4951-b8aa-09561e5b19fc2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Nighttime Cold and Flu ReliefNIGHTTIME COLD AND FLU RELIEFGrocery Outleta58459e3-6ada-4d99-9e22-1a01076761512026-03-25WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Sleep AidDIPHENHYDRAMINE HCLThe Kroger Co.0db543bb-c6c3-4370-a70c-e1652781fd7d2026-03-25WarningsExact identifier
unii: TC2D6JAD40
Good Neighbor Pharmacy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.01c04bad-3905-4776-b936-7b48ee6699df2026-03-25WarningsExact identifier
unii: TC2D6JAD40
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack09db348f-8396-41b2-b639-608dcfdbccf42026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)804d4b63-1bbe-47c0-ad49-39ddbeade6a32026-03-25WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and FluACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MGGrocery Outlet2f90dfb6-4257-44a8-a685-1873645d1c962026-03-25WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
good sense childrens pain and feverACETAMINOPHENPreferred Pharmaceuticals Inc.b5971407-2d95-4edb-88fe-0bd82d9116832026-03-25WarningsExact identifier
unii: 362O9ITL9D
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.397fe51d-b548-4fbb-8246-5f7c3ae80e972026-03-25WarningsExact identifier
unii: 04JA59TNSJ
childrens pain and feverACETAMINOPHENHyVee Inc9d9c2bf6-8660-4987-8794-936d3102da8d2026-03-24WarningsExact identifier
unii: 362O9ITL9D
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEGrocery Outlet, Inc.4d887ed0-4532-5125-e063-6394a90ac44d2026-03-24WarningsExact identifier
application number: M012
unii: 362O9ITL9D
DAYTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS HEALTH CORP2ba90b91-2e35-4701-e063-6294a90a75542026-03-24WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Mucus ReliefGUAIFENESIN 400 MGTWIN MED LLCe31bd69f-97ab-9d99-e053-2995a90a580e2026-03-24WarningsExact identifier
application number: M012
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd05620-30a3-9cea-e063-6294a90af18b2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen SPF 50SUNSCREEN SPF 50Guangzhou Ariel Biotech Co., Ltd.4dd1b722-4448-9675-e063-6294a90a5f4f2026-03-24WarningsExact identifier
unii: 15FIX9V2JP
Severe Sinus Congestion and Pain Maximum StrengthACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLBetter Living Brands, LLCb7b1c3cc-fdf3-4e75-8c3f-2e832f09a8872026-03-24WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
Nuvicare Long-Acting Cough ReliefDEXTROMETHORPHAN HYDROBROMIDENUVICARE LLCec1d3dd6-2a8b-4487-81a2-be6313e976102026-03-24WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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