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 77 of 438 · 8,744 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5431c1bf-469b-4944-a558-52d098c9b0f02026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacke5d6de20-c195-4b97-963a-2f3832e50b492026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack6fae7c90-1d80-4eb8-bbb8-8f945884f5c62026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
basic care nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmazon.com Services LLC76e19b9a-3bdb-479a-9503-9e8250109c842026-04-07WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
unii: 362O9ITL9D
BanophenDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.0f52270a-b11a-4fa1-aac2-9fe5ff6254192026-04-06WarningsExact identifier
unii: TC2D6JAD40
Diphenhydramine HClDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.d3f769d7-3cbb-4469-bff8-2015619ee1152026-04-06WarningsExact identifier
unii: TC2D6JAD40
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLPreferred Pharmaceuticals Inc.7fc05877-6ce8-4b2e-afba-9e043150e1c52026-04-06WarningsExact identifier
unii: TC2D6JAD40
equate daytime nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDEWALMART INC.7959ea00-2a41-4c3c-8c58-85795ebd2afc2026-04-06WarningsExact identifier
application number: M012
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: TC2D6JAD40
Cold and AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDOLGENCORP, LLCb55452e1-25d0-4db5-9621-83f21ec6c2982026-04-06WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Diphenhydramine HCLDIPHENHYDRAMINE HCLPreferred Pharmaceuticals, Inc.3ac0beba-303d-404e-bfec-0cf8c0e8624d2026-04-06WarningsExact identifier
unii: TC2D6JAD40
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack3bd8e7b1-e31c-4298-ba1e-eaf2a09542082026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepacka2e33ea3-941f-4810-b008-abbb109730a92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack79c3af61-19e7-40e5-bd20-2cea52f0bd3a2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Night Time Sleep AidDIPHENHYDRAMINE HCLHyVee Inccf94fa56-01a5-4d6c-ad08-38b0ea3633992026-04-03WarningsExact identifier
unii: TC2D6JAD40

Reported adverse events (FAERS/openFDA)#

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