FDA.reportPublic FDA data

NDC 77333-031-25 - Aspirin 81mg Enteric Coated

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
77333-031
Requested NDC
77333-031-25
Package NDCs from labels
77333-031-25, 77333-031-20
Manufacturer
Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED
Effective date
2026-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aspirin - Gendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITEDGendose Pharmaceuticals, LLC | ELYSIUM PHARMACEUTICALS LIMITED2026-10-06HUMAN OTC DRUG LABEL
Aspirin 81mg Enteric Coated - Cardinal Health 107, LLCCardinal Health 107, LLC2026-07-28HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77333-031-20Aspirin 81mg Enteric Coated150 in 1 CARTONTABLET, DELAYED RELEASE1501
77333-031-25Aspirin 81mg Enteric Coated1 in 1 BLISTER PACKTABLET, DELAYED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77333-031ASPIRIN 81MG ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [GENDOSE PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20250501_7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
77333-031-20EA - Each77333-03185eb169d-e2f9-45af-8243-e5450ed3cde812025-05-14
77333-031-25EA - Each77333-031f4575ebe-fdd0-4355-b91e-7fd0193f093a12025-05-14

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 30 of 219 · 4,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin MigraineACETAMINOPHEN, ASPIRIN, AND CAFFEINENavajo Manufacturing Company Inc.4efbd21b-92fe-96a7-e063-6294a90ac4ad2026-04-08WarningsExact identifier
unii: R16CO5Y76E
AspirinASPIRINHyVee Inc3730ee46-b241-44eb-94fa-52b9d12a9c352026-04-08WarningsExact identifier
application number: M013
unii: R16CO5Y76E
AspirinASPIRINWalgreen Company82cc404b-fcf5-4e48-ab1a-09d8c47f9e042026-04-08WarningsExact identifier
application number: M013
rxcui: 308416
unii: R16CO5Y76E
MIGRAINE FORMULAACETAMINOPHEN, ASPIRIN, CAFFEINEMeijer, Inc.529b6ee6-043c-430a-b2e1-b63c81f102912026-04-08WarningsExact identifier
unii: R16CO5Y76E
AcetaminophenACETAMINOPHENCardinal Health 107, LLC9efcce86-dd57-4ea2-ad31-d2038eb61bf12026-04-07WarningsExact identifier
application number: M013
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
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
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC201b860d-dc3c-4380-affa-e757bf2103cf2026-04-07WarningsExact identifier
application number: M013
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
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Pain RelieverACETAMINOPHENWalgreens6e7475e2-81a9-43b5-9b81-b58ab761a6f42026-04-07WarningsExact identifier
application number: M013
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
Pain Relief Aspirin Low DoseASPIRINRite Aid Corporation503408ed-e799-48a0-8d38-3034f4a0ead52026-04-02WarningsExact identifier
application number: M013
rxcui: 308416
unii: R16CO5Y76E
Aspirin 81 mgASPIRINLidl US LLC468f4a2f-60f7-4808-95d7-a00be1bb112f2026-04-02WarningsExact identifier
application number: M013
rxcui: 308416
unii: R16CO5Y76E
Childrens AcetaminophenACETAMINOPHENGrocery Outlet, Inc.44de6f5a-0b5c-6c28-e063-6394a90a7e0b2026-04-02WarningsExact identifier
application number: M013
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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