FDA.reportPublic FDA data

NDC 83059-0107-01 - Severe Sinus Congestion and Pain

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
83059-0107
Requested NDC
83059-0107-01
Package NDCs from labels
83059-0107-1, 83059-0107-01
Manufacturer
Shield Pharmaceuticals Corp
Effective date
2025-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Severe Sinus Congestion and Pain - Shield Pharmaceuticals CorpShield Pharmaceuticals Corp2025-11-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83059-0107-1Severe Sinus Congestion and Pain1 in 1 CARTONTABLET, COATED12
83059-0107-1Severe Sinus Congestion and Pain12 in 1 BLISTER PACKTABLET, COATED122

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 78 of 447 · 8,929 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINENavajo Manufacturing Company Inc.f7e572e9-82a7-2127-e053-6394a90ab01a2026-04-08WarningsExact identifier
unii: 362O9ITL9D
MidolACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATENavajo Manufacturing Company Inc.cabd10f2-a91e-4406-9249-915e306c867b2026-04-08WarningsExact identifier
unii: 362O9ITL9D
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
unii: 362O9ITL9D
Nasal Decongestant PE Maximum StrengthPHENYLEPHRINE HCLStrategic Sourcing Services LLC8460d4f9-8d7b-4ae4-8047-c2010d9c80132026-04-08WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCardinal Health 110, LLC. DBA Leaderd2dab450-cf82-4be2-a4e2-630295fb59ab2026-04-08WarningsExact identifier
application number: M012
Nighttime CoughDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEWalgreens4657c02b-887b-4746-8a78-83a72465e07b2026-04-08WarningsExact identifier
application number: M012
Menstrual Pain Relief Maximum Strength / Multi SymptomACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEDOLGENCORP, LLCd441088b-fb1d-4fdc-954f-032f3122212f2026-04-08WarningsExact identifier
unii: 362O9ITL9D
Leader Mucus ReliefGUAIFENESINCardinal Health 110, LLC. dba Leaderca735722-0baa-4c85-8311-17dbce915fc52026-04-08WarningsExact identifier
unii: 495W7451VQ
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack092f4694-98df-41bd-b37c-afbcda087e562026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
unii: 362O9ITL9D
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Mucus Relief Sinus Pressure Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED33646fab-79a5-4f10-8ac0-48423eac9b562026-04-07WarningsExact identifier
application number: M012
unii: 04JA59TNSJ
unii: 362O9ITL9D
unii: 495W7451VQ
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC1b164780-ec84-4187-8afa-6f8a0da550fc2026-04-07WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
unii: 362O9ITL9D
Thera Plus HemorrhoidalGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMFourstar Group USA, Inc.5d63bf97-29d2-4c71-97c3-85f425e862072026-04-07WarningsExact identifier
unii: 04JA59TNSJ
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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