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 97 of 215 · 4,283 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.6a86e5fd-6736-45e0-aa7d-d268fdaed4f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp61e50135-a7c2-4a86-8a1a-d47b41d3f9d12025-11-07WarningsExact identifier
application number: M013
e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.42a3625f-5c58-4ec5-895f-b14f744282712025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8e14fe81-cf7f-4a81-afec-e6c8466179c92025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.7dd9f4cb-78d8-4edc-a63c-d4a02930a0f82025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.8acb660f-94bd-4c4f-b0c1-3682cf8ed5432025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Fair 150 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.fad2bec7-c5f4-45f4-aff4-a5022033cb6a2025-11-07WarningsExact identifier
unii: 15FIX9V2JP
e.l.f Camo Semi-Matte CC SPF 30 Medium 355 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.39856c69-84fb-4b12-a713-8912263e42b12025-11-07WarningsExact identifier
unii: 15FIX9V2JP
Childrens ChewablesACETAMINOPHENStrategic Sourcing Services LLCaf2cbbaf-9b73-440a-bc88-a790cafccc6b2025-11-07WarningsExact identifier
application number: M013
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
unii: 15FIX9V2JP
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Aspirin Low DoseASPIRINL.N.K. International, Inc.39e142a7-8590-4e1e-8319-6904fb57cc8a2025-11-06WarningsExact identifier
application number: M013
unii: R16CO5Y76E
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC42321456-d7dd-3b51-e063-6394a90ac2922025-11-05WarningsExact identifier
application number: M013
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
unii: 15FIX9V2JP
Childrens Pain ReliefACETAMINOPHENFamily Dollar Services Inc76058eb3-2d3f-4414-87df-7167cd27d26b2025-11-05WarningsExact identifier
application number: M013
Children Pain and Fever ReliverACETAMINOPHENTarget Corporation1116f808-f61e-47ec-b0d0-d4be5aa905be2025-11-04WarningsExact identifier
application number: M013

Reported adverse events (FAERS/openFDA)#

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